Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

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Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced by the industry. This guidance marks the final version of two previous iterations of this guidance—the first was released in 2017 titled “Clinical and Patient Decision Support Software” and was replaced by the draft issued on September 27, 2019. FDA’s substantially revised final guidance reflects the industry’s concerns and questions voiced during the comment period of the 2019 draft guidance. The final guidance does away with the risk-based framework detailed in the 2019 draft guidance, and instead provides additional details regarding FDA’s interpretation of each statutory criterion for non-device classification along with more than thirty specific demonstrative examples of device and non-device CDS functions.  Interpretation of Section 520(o)(1)(E) CriteriaIn the 2022 final guidance, FDA provides additional clarification of its interpretation of each of the four criteria in Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act. In order for a software function to be excluded from the device definition by the provision, and considered a non-device CDS function, it must meet all four criteria. 1. Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition systemSoftware functions that are intended to acquire, process, or analyze medical images, signals from in vitro diagnostic devices (IVDs), or patterns or signals from signal acquisition systems will remain devices subject to FDA oversight. The final guidance provides additional clarification regarding the definitions of “medical image,” “signal,” and “pattern.” <ul><li>Medical Image: FDA generally considers the term “medical image” to include images generated by medical imaging systems for medical purposes, such as x-ray, CT, ultrasound, and MRI images. Images that were not originally acquired for medical purposes but are now being processed or analyzed for a medical purpose are also considered medical images.</li><li>Signal: FDA interprets the term “signal” to include signals that typically require use of an IVD or a signal acquisition system that measures a parameter from within, attached to, or external to the body for a medical purpose. This often includes, but is not limited to, use of sensors, collection of samples or specimens, or use of radiological imaging systems. </li><li>Pattern: FDA interprets the term “pattern” in this context to refer to multiple, sequential, or repeated measurements of a signal or from a signal acquisition system. For example, for an electrocardiogram (ECG), an electrical signal is acquired from the body and processed to create an ECG waveform and QRS complex. For continuous glucose monitors, a photometric or electrochemical signal generated by an assay and instrument is processed to generate glucose measurements over time. These repeated measurement outputs are considered patterns.  </li></ul>FDA considers software functions that assess or interpret the clinical relevance of a signal, pattern, or medical image to fail this first criterion because they acquire, process, or analyze the data. For example, software functions that process or analyze an electrochemical or photometric response generated by an assay and instrument to generate a clinical test result do not meet the first criterion.2. Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical informationFDA interprets “medical information about a patient” to mean the type of information that is normally communicated “between HCPs in a clinical conversation or between HCPs and patients in the context of a clinical decision, meaning that the relevance of the information to the clinical decision being made is well understood and accepted.” This includes software functions that display, analyze, or print patient-specific information like demographic information, symptoms, test results, and/or other medical information such as peer-reviewed clinical studies or clinical practice guidelines. In the final guidance, FDA identified sampling frequency as an important consideration in determining if information is considered “medical information” or a “signal” or “pattern.” FDA considers a “single discrete test or measurement result that is clinically meaningful (e.g., a blood glucose lab test result)” to be medical information, while a more continuous sampling of the sample information (e.g., continuous glucose monitor readings) would be considered a pattern or signal. FDA clarified that it “recognizes there is a continuum between a single sample and a continuous sample” and included more detailed examples for reference. 3. Intended for the purpose of supporting or providing recommendations to an HCP about prevention, diagnosis, or treatment of a disease or conditionFDA interprets this criterion to refer to software that provides condition, disease and/or patient-specific recommendations to a health care provider (HCP) “to enhance, inform and/or influence a health care decision but is not intended to replace or direct the HCP’s judgment.” In the final guidance, FDA expands on this criterion, adding two factors for consideration in determining whether a software function is being used to support or provide recommendations to an HCP: (1) the level of software automation and (2) the time-critical nature of the HCP’s decision-making. Both factors will be considered in determining whether a software function is being used to enhance, inform, and/or influence, or rather to substitute, replace, or direct the HCP’s judgment.In the final guidance, FDA dives into a discussion about automation bias in the context of CDS functions and the errors of commission or omission that may result if software provides an HCP user with a single, specific output or solution, especially in time-critical circumstances that require urgent action. FDA highlights instances involving time-critical decision-making and cases where software provides that a specific preventive diagnostic or treatment directive is failing this criterion because it is not intended to support or provide recommendations. Examples include software that provides a specific diagnostic or treatment course, a specific follow-up directive, or time-critical alarms and alerts intended to trigger potential clinical intervention to assure patient safety. The focus of this criterion is the preservation of HCP decision-making and judgment. Software functions that meet this criterion are those that provide evidence-based tools and make recommendations based on analysis of patient-specific information that an HCP may incorporate into its holistic decision-making process.  4. Intended for the purpose of enabling an HCP to independently review the basis for the recommendations that the software presents, and not intended that the HCP should rely primarily on any of those recommendations to make a clinical diagnosis or treatment decision regarding an individual patientThere were many questions from stakeholders in the industry regarding this fourth criterion and the requirements for satisfying independent review. In response, the new final guidance recommends that software or labeling:<ul><li>Include the purpose or intended use of the product, including intended HCP users and intended patient populations</li><li>Identify the required input medical information, with plain language instructions on how the inputs should be obtained, their relevance, and data quality requirements</li><li>Provide a plain language description of the underlying algorithm development and validation that forms the basis for the CDS implementation, including:</li><ul><li>Summary of the logic or methods relied upon to provide the recommendations,</li><li>Description of the data relied upon, and</li><li>Description of the results from any clinical studies conducted to validate the algorithm/recommendations.</li></ul></ul>In addition, FDA recommends the software outputs provide the HCP users with relevant patient-specific information and other known/unknown factors for consideration by the HCP in applying its judgment. In response to industry comments and questions regarding the difficulties associated with software complexity and proprietary information, FDA clarified that regardless of the complexity or proprietary nature of the software, the outputs or labeling “should provide adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation.” Relevant sources should be identified, available, and communicated in a way that is understandable to the intended users.  Device and Non-Device CDS Function ExamplesThe final guidance provides many specific examples of types of software that may be considered non-device CDS functions assuming they meet the requirements of the fourth criterion. These include, for example:<ul><li>Software functions that match patient-specific medical information to reference information routinely used in clinical practice to facilitate assessments of specific patients, like a software function that uses patient diagnosis and other medical information to provide an HCP with current practice treatment guidelines for common conditions such as influenza, hypertension, and hypercholesterolemia; </li><li>Software functions that analyze family history, prior mammogram results, and BRCA1 status from the medical record and recommend that an HCP consider increased mammography frequency or supplemental breast ultrasound for the patient;</li><li>Software functions that analyze the type of arthritis diagnosis in a patient record and identify prioritized treatment options available for that condition; and</li><li>Software functions that interpret daily results of a basic metabolic panel for a hospitalized patient and recommend several options for IV fluids that may be beneficial to ensure proper hydration and to prevent acidosis.</li></ul>The final guidance also provides examples specifically intended to clarify FDA’s interpretation of the fourth criterion—independent HCP review—as well as 34 separate examples of device software functions on which FDA intends to focus its regulatory oversight.Patient/Caregiver Decision SupportThe final guidance eliminates software functions that support or provide recommendations to patients or caregivers from the CDS function exclusion and will regulate that software as medical devices. FDA stated its intention to be consistent with existing policies in the regulation of CDS intended for non-HCPs and “will update existing policies, as appropriate, with additional examples as CDS for non-HCPs continues to evolve.”

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA Releases Foundational Digital Health Guidance

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On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced by the industry. This guidance marks the final version of two previous iterations of this guidance—the first was released in 2017 titled “Clinical and Patient Decision Support Software” and was replaced by the draft issued on September 27, 2019. 

FDA Releases Foundational Digital Health Guidance

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is asking for notifications of intent to develop monkeypox diagnostic tests by October 13, 2022. On August 4, 2022, HHS Secretary Becerra declared a <a href="https://www.hhs.gov/about/news/2022/08/04/biden-harris-administration-bolsters-monkeypox-response-hhs-secretary-becerra-declares-public-health-emergency.html" target="_blank">Public Health Emergency</a> acknowledging the ongoing rapid transmission of monkeypox and the necessity of an urgent response. In a public health emergency, FDA requires in vitro diagnostic tests, including laboratory developed tests, to undergo premarket review to ensure the accuracy and reliability of such testing. To speed the availability of these tests, FDA has unique authorities during an emergency to issue emergency use authorizations (“EUAs”) under an expedited review process created by section 564 of the Federal Food, Drug, and Cosmetic Act. On September 7, 2022, Secretary Becerra signed a section <a href="https://www.hhs.gov/about/news/2022/09/07/hhs-secretary-becerra-issues-564-declaration-to-expand-the-availability-of-testing-for-monkeypox.html" target="_blank">564 Declaration</a> allowing FDA to use its EUA authority for in vitro diagnostics to more rapidly expand testing availability.To aid developers in preparing EUA submissions, on September 13th FDA issued a final guidance: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-monkeypox-tests-address-public-health-emergency" target="_blank">Policy for Monkeypox Tests to Address the Public Health Emergency</a>. As noted in the guidance, “FDA intends to prioritize review of EUA requests for high-throughput diagnostic tests, tests with home specimen collection, or rapid all from experienced developers with high manufacturing capacity.” Significantly, FDA requested interested parties send an intent to submit an EUA by October 13, 2022. It should be noted that FDA does not expect EUA requests for certain validated diagnostic LDTs that are developed and performed in a single lab, that uses PCR, and when the only sample type is a lesion swab sample from a potential monkeypox lesion.FDA also issued an EUA template and summary template for molecular diagnostic tests, which are available for download on <a href="https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices">Monkeypox Emergency Use Authorizations for Medical Devices</a>. For general FAQs and regular updates, FDA is maintaining a Frequently Asked Questions page available here: <a href="https://www.fda.gov/medical-devices/monkeypox-and-medical-devices/faqs-testing-monkeypox">FAQs on Testing for Monkeypox</a>.Since issuing the declaration, FDA has issued one emergency use authorization for a <a href="https://www.fda.gov/media/161454/download" target="_blank">multiple target, Real-Time PCR test</a>. This test is joined on the market by the CDC-developed, FDA-cleared non-variola Orthopoxvirus (“NVO”) assay. FDA has further clarified that there are no current shortages of monkeypox tests, test kits, nor reagents, especially the CDC NVO assay.In addition, leadership from FDA’s CDRH Diagnostics Office (OHT7) will now host a weekly virtual town hall for monkeypox test developers beginning September 21, 2022 (12:05 - 1:00 p.m. ET). The webinar, in a similar format to the virtual town hall for COVID-19 test developers, will include announcing updates, addressing previously emailed questions, and answering live questions. Now that the town hall for COVID-19 test developers occurs on a monthly basis, there will be a monthly combined town hall addressing both COVID-19 and monkeypox updates and questions beginning on September 28, 2022 (12:05 - 1:00 p.m. ET). For monkeypox virtual town hall details, please visit the Virtual Town Hall Series - Monkeypox Test Development and Validation.MoFo’s FDA + Healthcare Regulatory and Compliance practice is following these developments closely and assisting developers in the preparation of their notifications and submissions. We look forward to assisting test developers as they respond to this unfolding public health emergency.

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New Opportunities for Test Developers: Monkeypox Diagnostics

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For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. 

New Opportunities for Test Developers: Monkeypox Diagnostics

On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a <a href="https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-16299.pdf">Notice</a> in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings before the USPTO or Patent Trial and Appeal Board (PTAB). It is an outgrowth of President Biden’s 2021 <a href="https://lifesciences.mofo.com/topics/biden-administration-executive-order-on-promoting-competition-in-the-american-economy-drug-pricing-and-healthcare-industry-initiatives">Executive Order on Promoting Competition in the American Economy</a>, in which the acting U.S. Food and Drug Administration (FDA) Commissioner <a href="https://www.uspto.gov/sites/default/files/documents/EO14036-FDALettertoPTO.pdf">wrote to</a> the acting USPTO Director highlighting numerous areas in which the USPTO and FDA could work together to reduce drug costs. In particular, the Notice emphasized the duty to disclose material information and statements from communications with the FDA. Companies that make submissions to both the USPTO and the FDA, such as pharmaceutical companies and medical device manufacturers, should pay special attention to the Notice.Disclosing Information Received from the FDAAs part of an abbreviated new drug application (ANDA), generics can provide arguments that patents covering the innovator drug are invalid in a Paragraph IV certification. The Paragraph IV certifications are then communicated to the patent owners by the FDA.The duty of “reasonable inquiry” under 37 C.F.R 11.18(b)(2) requires that each party submitting a paper to the USPTO perform an inquiry that is reasonable under the circumstances to confirm the accuracy and consistency of statements made therein, but does not detail what is involved in a reasonable inquiry.The Notice now expressly clarifies that the duty of reasonable inquiry includes reviewing paragraph IV certifications received by patent owners to determine their materiality to patentability of any pending matters before the USPTO. “If the content of the detailed statement, or other information that is part of the ANDA process, is deemed material to patentability in a pending USPTO matter, then such information must be submitted to the USPTO during the pendency of the matter, to meet the duties of candor and good faith and disclosure under 37 CFR 1.56, 1.555, 42.11(a) or (c), or 11.18(b)(2),” the Notice states.Additionally, the Notice warns that merely submitting the FDA’s listing of paragraph IV certifications to the USPTO does not satisfy the duty of disclosure, since these lists “do not include patent numbers, relevant claims, or an explanation of the basis for the certification.”Importance of Consistency in Statements Before the USPTO and FDAThe Notice underscores the importance of consistency in statements made before the USPTO and the FDA. Specifically, the Notice states that “providing material information to other Government agencies, including the FDA, while simultaneously withholding the same information from the USPTO undermines both the intent and spirit of the duty of disclosure and violates those duties.”A recent Federal Circuit decision, <a href="https://cafc.uscourts.gov/opinions-orders/20-1799.opinion.9-1-2021_1828017.pdf">Belcher Pharmaceuticals v. Hospira</a> (Fed. Cir. Sept. 1, 2021), was cited as an example in which “inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market—can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product.”In <a href="https://www.ipwatchdog.com/2021/09/02/federal-circuit-upholds-delaware-courts-inequitable-conduct-analysis/id=137298/">Belcher</a>, the Federal Circuit affirmed a district court’s ruling that a patent covering a formulation of the drug epinephrine is unenforceable due to inequitable conduct. In a new drug application (NDA) filed with the FDA, Belcher’s Chief Scientific Officer had submitted several prior art references disclosing an “old” pH range for the epinephrine formulation. During prosecution before the USPTO, however, Belcher failed to disclose the references submitted to the FDA, and argued that the claims were patentable because the same pH range was “was unexpectedly found to be critical by the Applicant to reduce the racemization of l-epinephrine.”Key TakeawaysBelcher illustrates the key tension between relying on existing information for regulatory approval and establishing novelty and non-obviousness for patentability purposes. Parties involved in proceedings before the USPTO or PTAB that are seeking FDA approval should take special care to ensure consistency and coordination of strategies. As part of the duty of reasonable inquiry, parties should ensure that information and statements received from or submitted to the FDA are reviewed by both FDA regulatory counsel and patent counsel for potential materiality to patentability and disclosure to the USPTO or PTAB. This duty cannot be avoided by deliberate schemes to prevent individuals with the duty of disclosure from obtaining knowledge of material information, which the Notice indicates is “inappropriate.”Finally, parties should err on the side of disclosure to avoid allegations of inequitable conduct. As stated in the Manual of Patent Examining Procedure and reiterated in the Notice, “[in] close cases where the materiality or consistency of the information is in question, the applicant should consider submitting this information to the USPTO.” Given the significant leadership attention this topic has received at both the FDA and the USPTO, and the political pressure on both agencies to assist in the Biden administration’s efforts to reduce drug costs, the FDA and USPTO are likely both considering enforcement tools that may be employed to ensure appropriate disclosures.

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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Patent Agent

Building on her research experience in cellular and molecular biology, Dr. Kelsey Roberts Kingman focuses her work on patent drafting and assisting prosecution, patent analysis, and patent due diligen

Kelsey J. Roberts Kingman Ph.D.

Kelsey Roberts Kingman

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Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

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On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. 

Research assistant Nicole Gebert contributed to this article.<a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html">Part 1</a> of this article discussed the background and purpose of the <a href="https://eur-lex.europa.eu/eli/reg/2017/746/oj" target="_blank">EU In Vitro Diagnostic Regulation (EU) 2017/746</a> (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system, conformity assessments, and the role of notified bodies. This was followed by <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">part 2</a>, where we discussed clinical evidence, post-market surveillance, and transition periods. We will now focus specifically on requirements for medical device software (MDSW) as an IVD (IVD-MDSW) and the delimitation between the application of the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745">EU Medical Device Regulation (EU) 2017/745</a> (MDR) and application of the IVDR to a software device.<h2>Qualification as IVD-MDSW</h2>As already mentioned in<a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank"> part 1</a> of this article, the expanded IVDR definition of “in vitro diagnostic medical devices” in Article 2 (2) now explicitly includes software.IVD-MDSW usually occurs in the following forms:<ul><li>Software itself as an IVD</li><li>Software as an accessory for an IVD</li><li>Software driving or influencing the use of an IVD</li></ul>The first stage in determining whether the software is an IVD-MDSW subject to the IVDR is to confirm that the software is a medical device (MDSW).<ul><li>The Medical Device Coordination Group (MDCG) guideline <a href="https://ec.europa.eu/docsroom/documents/37581?locale=en" target="_blank">MDCG 2019-11</a> clarifies that MDSW is software intended to be used alone, or in combination, for a purpose as specified in the definition of “medical device” in the MDR or IVDR (for more information on the intended purpose of MDSW under the MDR, see part 2 our <a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html" target="_blank">MDR blog series</a>). In general, software that processes, analyses, creates, or modifies medical information will qualify as MDSW if it is intended to have a medical purpose. Software for non-medical purposes, or for general purposes, even when used in a healthcare setting, or software intended for well-being purposes, is not covered by the MDR and IVDR. Software that merely used to store, archive, or performs simple searches on medical data does not qualify as MDSW.</li></ul>Second, the software must meet the following criteria to qualify as IVD-MDSW:<ul><li>The MDSW provides information within the scope of the definition of IVDs; </li><li>MDSW creates information based on data obtained by an IVD only; or</li><li>The intended purpose of the MDSW is substantially driven by data sources coming from IVDs.</li></ul>In accordance with the second step, an MDSW that analyses maternal parameters such as age, concentration of serum markers, and information obtained through various IVD assays, as well as fetal ultrasound examination to evaluate the risk of trisomy 21, may be considered an IVD-MDSW as the intended purpose is substantially driven by IVD data.MDSW that does not fulfill this second step is covered exclusively by the MDR. This includes, for example, MDSW that assesses the level of risk to initiate care processes that help reduce intensive care unit (ICU) transfers, readmissions, adverse events, and the duration of stay, by considering risk assessment parameters like respiratory rate, heart rate, blood pressure, and SpO2, by default, and can be configured by the user to include other parameters as well, including results from in vitro medical diagnostic devices. This MDSW would fall under the MDR as (i) the data is obtained from both IVDs and medical devices, and (ii) the data obtained from the IVD is not critical to the output, so the information derived from the medical device is more relevant to the intended purpose.<h2>Risk Classification of IVD-MDSW According to the IVDR</h2>In <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank">part 1</a> of this article, we discussed the adoption of a new classification system. We also pointed out that the IVDR does not contain software-specific classification rules, like Rule 11 of Annex VIII to the MDR. Therefore, the classification of MDSW under the IVDR requires consideration of all classification and implementation rules of Annex VIII to the IVDR.The classification system of the IVDR considers the intended purpose of the device and the inherent risks, and groups devices into four different risk classes (classes A to D) in ascending order of their risk intensity. For example, software for the interpretation of automated readings of line immunoassay for the confirmation and determination of antibodies to HIV-1, HIV-1 group O, and HIV-2 in human serum and plasma, may be a device intended to be used for determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management under rule 1 of Annex VIII to the IVDR and would thus be classified in class D. At the same time, the IVD-MDSW referred to above, which uses maternal parameters and information obtained through fetal ultrasound examination to evaluate the risk of trisomy 21, may be considered a device that is intended for screening for congenital disorders in the embryo or fetus under Rule 3 (l) of Annex VIII to the IVDR and should thus be in class C.However, given the close nature of the MDR and the IVDR, there are of course similarities in the regulation of MDSW. Very similar to the risk assessment under the software-specific rule 11 of Annex VIII to the MDR (i.e., which effectively provides for class IIa ranking as a default result and therefore requires notified body review of most MDSW), the risk assessment of MDSW under the IVDR will in most cases result in a class B ranking (or higher) and therefore also require the IVD-MDSW to undergo an conformity assessment by a notified body. This is because IVDs, including IVD-MDSW, which are not covered by any specific classification rule, fall under class B by default (Rule 6 of Annex VIII of the IVDR).<h2>Technical Documentation for IVD-MDSW</h2>Before placing IVDs on the market, most manufacturers will need to get their technical documentation assessed by a notified body (see <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank">part 1</a> of this article for IVDR conformity assessment routes). The IVDR stipulates several software-specific requirements for the technical documentation in Annex II:<ul><li>The device description and specification should include a description of any software that drives the device or influences use of the device (Annex II 1.1.k).</li><li>For IVDs that incorporate software, the design information should include a description of any software to be used with the device, as well as an overview of the entire system. If the IVD uses software for objective data interpretation, or if the software is independent of any other device, a description of the data interpretation methodology, namely the algorithm, should be included (Annex II 3.1).</li><li>The documentation should further contain evidence of software validation as used in the finished device, as well as address all hardware configurations and, where applicable, operating systems identified in the labeling (Annex II 6.4, EN ISO/IEC 62304 is considered the state of the art approach).</li></ul>Several guidelines for IVDR technical documentation submissions have been issued by notified bodies and should be taken into consideration when dealing with the respective notified body (e.g., TÜV Rheinland, BSI).<h2>Introduction of a Unique Device Identification Requirement for IVD-MDSW</h2>The IVDR, like the MDR, introduces the Unique Device Identification (UDI) system. Annex VI Part C 6.2 of the IVDR addresses the UDI assignment for software specifically. In accordance with the IVDR, software that is commercially available on its own (i.e., standalone IVD-MDSW), as well as software that constitutes an IVD device, shall be subject to UDI requirements. These requirements are identical for MDSW under the MDR and for IVD-MDSW under the IVDR. More details on how to identify software devices can be found in <a href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe--New-Regulatory-Regime-About-To-Enter-Into-Force--Part-5-of-6.html" target="_blank">part 5</a> of our blog series on the MDR.<h2>IT Security</h2>Among the many novelties introduced, the IVDR and the MDR aim to ensure that devices placed on the EU market are suitable for the new technological challenges associated with cybersecurity risks.IVDs must thus be designed and manufactured in a way that removes or reduces risks associated with the possible negative interaction between software and the IT environment in which it operates and interacts (Annex I Chapter II 13.2.d). Manufacturers must establish, implement, document, and maintain a risk management system. Particularly with the complexity of software development, software configuration, and interdependencies between software components, IVD-MDSW is afflicted with security vulnerabilities. It is therefore considered more reasonable that software as such is subject to foreseeable misuse. Manufacturers should foresee or evaluate the potential exploitation of those vulnerabilities.Manufacturers must also develop and manufacture IVD-MDSW in accordance with the state of the art, while taking into account the principles of development lifecycle and risk management, including information security, verification, and validation. Manufacturers also need to set out minimum requirements concerning IT network characteristics and IT security measures, including protection against unauthorized access (Annex I Chapter II (16) IVDR).Further information can be found in the MDCG Guidance on Cybersecurity for medical devices (<a href="https://ec.europa.eu/health/system/files/2022-01/md_cybersecurity_en.pdf" target="_blank">MDCG 2019-16</a>).<h2>Performance Evaluation of IVD-MDSW</h2>Although the IVDD already required a performance assessment, it was only implied, not explicitly stated, and primarily concerned with the analytical performance of the device. Under the IVDR, any software that qualifies as an IVD must meet all clinical evidence and performance evaluation principles explicitly outlined in Article 56 (1) and Annex XIII of the IVDR. The MDCGs Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (<a href="https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf" target="_blank">MDCG 2020-1</a>) aims to provide the framework for the determination of the appropriate level of clinical evidence required for MDSW to fulfill the requirements set out in the IVDR (and MDR).Although the definition of clinical evaluation in the MDR and performance evaluation in the IVDR are not identical, sufficient clinical evidence is expected in both cases to demonstrate compliance with the relevant general safety and performance requirements.When collecting clinical evidence for IVD-MDSW, three key elements should be taken into account:<ul><li>Scientific validity;</li><li>Analytical performance; and</li><li>Clinical performance.</li></ul>Part A of Annex XIII applies primarily to the pre-market phase and defines performance evaluation as a three-step process: (i) drafting a performance evaluation plan, (ii) collecting data to demonstrate scientific validity and analytical and clinical performance, and (iii) evaluating and documenting the data in a performance evaluation report.Part B of Annex XIII concerns the post-market phase and outlines the requirements for post-market performance follow-up. This concept was not included in the IVDD, but is in line with the practice of many manufacturers to conduct a periodic “state of the art” review.<h2>Concluding Remarks</h2>Under the IVDR, IVD-MDSW is subject to several software specific requirements. As most IVD-MDSW will likely end up in class B or higher, manufacturers will also need to undergo notified body review in order to be able to place IVD-MDSW on the market. Therefore, it can be expected that a number of manufacturers will make use of the transition periods discussed in <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">part 2</a> of this blog series. However, as discussed in more detail in <a href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe-new-regulatory-regime-to-enter-into-force-part-6.html" target="_blank">part 4 of our blog series on MDSW under the MDR</a>, in particular MDSW manufacturers should be aware of the implications that come along with the use of transition periods as the IVD-MDSW may not undergo any significant changes to its design or intended purpose in order to benefit from such transition periods.

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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Counsel

Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

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Research assistant Nicole Gebert contributed to this article.
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulati

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)

Lindy Pittman, Summer Associate in Washington, D.C., contributed to the drafting of this post.The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD) tests, not just COVID-19 tests. During the height of the pandemic and while inundated with COVID-related submissions, CDRH restricted the IVD tests it would review in order to best address the public health crisis. Starting June 1, 2022, CDRH is again accepting all IVD pre-submissions, both COVID-related and other. However, the Center did include the caveat that non-COVID pre-submissions will likely still face an extended timeline, given the ongoing pandemic and associated workload.In another return to normalcy, CDRH plans to rescind an additional COVID-era policy that extended the grace period for deficient marketing submissions. Recognizing the effect the pandemic had on business operations, CDRH did not consider an application automatically withdrawn if CDRH did not receive a response by a certain date. Moving forward, the Center will be returning to its previous guidelines that require either a complete response or an extension request within the specified time. This policy change will go into effect 30 days after the official announcement from the FDA in the Federal Register, planned for June 7, 2022.For another point to watch, the Medical Device User Fee Amendment (MDUFA) commitment letter is currently moving through Congress. CDRH has committed to increasing communication between the FDA and submission applicants in order to reduce wait times.

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests

Is 2021 the Value-Based and Shared Savings Revolution?

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Lindy Pittman, Summer Associate in Washington, D.C., contributed to the drafting of this post.
The U.S. Food and Drug Administration (FDA) released a statement 

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests