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.

Meghan Poon

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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In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

Federal Circuit Clarifies Requirements for Prior Art Under Pre-AIA 35 U.S.C. § 102(e)

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product approvals, and post-approval monitoring of drugs.“Overall, the draft guidance aligns with other steps FDA has undertaken, including the ongoing Complex Innovative Trial Design Pilot Meeting Program, which is intended to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs,” the authors wrote. “Such innovative trial designs offer the prospect of greater efficiency and smaller cohorts of participants by sharing control arms and studying multiple agents in the course of the same study.”They added: “The goals of this draft guidance also appear to align with the industry guidance FDA issued for sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19 in which FDA has discussed how novel study design models can help researchers “do more with less” through more judicious use of human subjects in research and greater use or re-use of existing data sources. For instance, in the COVID-19 master protocol guidance, the agency has endorsed adoption of more complex research models that either share control arms, draw more heavily on existing data, or use data iteratively to refine the study on an ongoing basis, such as via Bayesian models in which results in one stage of a study can influence what variables or interventions are examined in the next. Master protocols are research plans that govern studies designed to examine multiple therapies, multiple diseases, or both, in the context of a single research study. In its guidance on the use of master protocols, the agency has articulated the potential public health benefits that could accrue from more flexible research designs, while emphasizing that with complexity can come increased risk of confusion or error. As the FDA has indicated its receptiveness to innovative research modalities, it has also made clear that its underlying high standards for scientific rigor remain unchanged.”Read the <a href="https://www.clinicalleader.com/doc/fda-releases-draft-guidance-on-use-of-real-world-evidence-for-drug-biological-products-0001" target="_blank">full article</a>.

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FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

Is 2021 the Value-Based and Shared Savings Revolution?

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Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its lates

FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021.  The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022.  The session included presentations from Ann Oxenham (CFSAN), William Maisel (CDRH), and Donald Ashley (CDER).Below are key takeaways from some of the panels:1. CFSAN – Focus on Undeclared Allergens: Ann Oxenham highlighted the division’s 2021 accomplishments, including seizures, injunctions, and warning letters.  In particular, she emphasized warning letters issued for undeclared food allergens, which were the leading cause of class 1 food recalls in the past year.  Oxenham noted that FDA is working to improve industry compliance with regard to food allergen requirements, and is conducting inspections and sampling to check that major food allergens are properly labeled and that food facilities implement appropriate controls.In 2021, FDA issued seven <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whole-foods-market-610862-12162020">warning letters</a> to facilities that manufactured and distributed food with undeclared allergens. Oxenham noted that, “although retail establishments are generally excluded from certain requirements, they are responsible for ensuring that the labeling for food manufactured under their brand name and the labeling they perform in the store is accurate with respect to allergens.”  In 2022, CFSAN will continue its particular focus on undeclared allergens.2. CDRH – FDA Inspection Priorities: William Maisel discussed CDRH’s continued focus on fraudulent COVID-19 products and the status of FDA inspection oversight.  CDRH is currently operating at its base case scenario, with domestic surveillance inspections resuming and foreign inspections occurring if mission-critical.  Maisel noted that CDRH is prioritizing using a risk-based approach, and anticipates the use of remote regulatory assessments for medical device evaluations continuing in the future. Maisel also highlighted the increased use of the Medical Device Single Audit Program (MDSAP).  MDSAP allows a recognized third-party auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program, including the FDA.  In the past year, more than 2,000 MDSAP audit reports were used in lieu of FDA surveillance inspections, and FDA will continue to accept MDSAP audit reports as a substitute for routine agency inspections.In addition, FDA is working to harmonize and modernize the Quality System regulation, with revisions to supplant existing requirements with the specifications of ISO 13485.  Maisel noted that the proposed rule is coming soon.3. CDER – Novel cGMP Compliance Actions: Donald Ashley highlighted the novel compliance actions developed during the pandemic, including analytical testing of drugs at the border and import alerts.  Some of these measures were developed to address methanol-contaminated hand sanitizers imported into the U.S. and FDA issued the first-ever warning letters based upon analytical testing of samples collected at the border.  FDA also issued the first-ever warning letters based on 704(a)(4) records requests, as well as warning letters based on the refusal of those records requests.Ashley also noted FDA’s <a href="https://www.fda.gov/drugs/drug-safety-and-availability/notification-pharmaceutical-companies-clinical-and-bioanalytical-studies-conducted-panexcell">public notification</a> informing industry that clinical and bioanalytical studies conducted by Synchron Research Services and Panexcell Clinical Lab were not acceptable in NDAs and ANDAs because of data-integrity concerns.  Applications using studies conducted by these CROs will need to be repeated, and this has affected more than 100 drug applications.For questions on any of the topics discussed, please contact the authors or a member of <a href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html">MoFo’s FDA Regulatory + Compliance practice</a>.

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3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session

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FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021.  The session titled Compliance Central with FDA Center Compliance 

3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session

FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of focus and continued priority for 2022.Below are three key areas of focus:<ol><li>COVID Fraud. Misconduct related to the pandemic and COVID-19 was and remains a top priority. The Consumer Protection Branch will continue its collaboration with the Federal Trade Commission (FTC) to address COVID fraud and prevent fake and unapproved treatments and cures from reaching consumers. Rao noted that the FTC is referring an increasing number of civil penalty actions to the Consumer Protection Branch, and DOJ will continue to pursue civil and criminal penalties where applicable.</li><li>Opioids. The opioid epidemic remains a key area of focus for the Consumer Protection Branch. Rao pointed to examples of recent enforcement action, including Walmart and Purdue, and noted that the Consumer Protection Branch continues to pursue injunctive and civil penalty actions against local pharmacies, pharmacists, and prescribers in addition to manufacturers. Rao reiterated that it is important for manufacturers creating a product that can be used to manufacture a controlled substance to know their customers.</li><li>Clinical Trial Fraud. Rao highlighted two recent cases in Southern Florida, Unlimited Medical Research and Tellus Clinical Research, both of which involved clinical trial fraud schemes involving fabricated data and falsifying data and medical records. The Consumer Protection Branch expects to bring further actions in the coming months.  The increase in use of remote clinical trial monitoring during the pandemic may contribute to an increase in clinical trial fraud enforcement actions going forward.</li></ol>For questions on any of the topics discussed, please contact the authors or a member of MoFo’s <a href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html" target="_blank">FDA Regulatory + Compliance practice</a>.

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Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address

Privacy Litigation 2020 Year in Review: BIPA Litigation

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FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Departme

Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address

Stacy Amin and Bethany Hills, co-chairs of our FDA Regulatory + Compliance practice, authored an article for Law360 discussing the U.S. Department of Health and Human Services (HHS) withdrawing a controversial Trump administration policy that prohibited the U.S. Food and Drug Administration (FDA) from requiring premarket review of laboratory-developed tests (LDTs), addressing the most common questions about the new policy, and making predictions for 2022 and beyond.“This enforcement approach by the FDA has widely been referred to as shifting sands, where the industry is not quite sure when the FDA might take a compliance action or when its policy of enforcement discretion might change. So the recent announcement by HHS has led to a host of questions about what going back to the past might mean for the future.”Read the full article <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blt9492576886d5c012/6273178fa1a1dd2aa9f6ca4a/211214-new-pda-policy-covid-tests.pdf" target="_blank">here</a>. Refer to our client alert and recorded discussion, <a target="_blank" href="https://lifesciences.mofo.com/topics/HHS-reverses-policy-prohibiting-FDA-review-of-lab-developed-tests.html">HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests</a>.

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What New FDA Policy Means for COVID Tests and Beyond

Virginia Becomes the First State to Adopt COVID-19 Workplace Safety Mandates

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Stacy Amin and Bethany Hills, co-chairs of our FDA Regulatory + Compliance practice, authored an article for Law360 discussing the U.S. Department of Health and

What New FDA Policy Means for COVID Tests and Beyond

On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the <a target="_blank" href="https://www.federalregister.gov/documents/2021/10/05/2021-21677/medical-device-de-novo-classification-process">final rule</a>, Medical Device De Novo Classification Process, and <a target="_blank" href="https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-request">associated guidance document updates</a>. The final rule, which will take effect on January 3, 2022, codifies the medical device De Novo classification process by adding new regulations at 21 CFR Part 860, Subpart D. Dr. Peter Yang, De Novo Program Lead at the FDA Center for Devices and Radiological Health (CDRH), led the webinar. Dr. Yang described the new De Novo regulations, explained how the regulations may or may not change the current De Novo review process, and answered questions from various interested parties.A De Novo request is a type of premarket submission, requesting the FDA to classify a novel device into class 1 or class 2 based on a determination of reasonable assurance of safety and effectiveness (RASE). If the De Novo request is granted, the FDA creates a new classification regulation and the De Novo device can serve as the first predicate device of its kind. Subsequent requests will be a 510(k). While the final rule largely reflects the current review process, the FDA highlighted a few areas that stakeholders might be interested in.<ul><li>Refuse-to-Accept (RTA) Checklist. The most significant change is the updated acceptance checklist. 21 CFR 862.220 lists the De Novo request content, and 21 CFR 862.230 provides the acceptance review process. The current RTA checklist includes two parts: a required checklist (Appendix A) and a recommended checklist (Appendix B). With this new regulation, almost all the elements from Appendix A and Appendix B are now required elements. Specifically, the new checklists add items such as prior submission, classification summary (eligibility analysis), and device labeling. The FDA will perform an acceptance review within 15 days of receipt. The file is automatically accepted if the acceptance review is not performed.</li></ul><ul><li>Classification Procedure. The FDA aims to meet three goals when reviewing a De Novo request: (1) determining if the probable benefits outweigh the probable risk, (2) identifying probable risks to health for the device/product, and (3) based on the risks to health, determining the level of regulatory controls needed to mitigate the risk. If the FDA concludes that either general controls or both general and special controls will provide a reasonable assurance of safety and effectiveness, a De Novo request will be granted. The entire review will take 150 FDA days, a performance goal set by MDUFA IV, which is different than the statutory deadline of 120 FDA days.</li></ul><ul><li>Premarket Manufacturing Inspection. The final rule gives the FDA a new authority to conduct premarket manufacturing inspection, codified in 21 CFR 860.240. The FDA clarifies that the inspection will only affect “a small percentage” of De Novo requests and is limited to (1) data integrity concerns and (2) quality system regulation when devices have critical or novel manufacturing processes that may affect the safety and effectiveness of the product. For example, if a device proposes to use a novel sterilization technique, the FDA might want to inspect the facility to understand how the sterilization process functions. The sponsors will receive notification prior to any inspections with no specific timeframe.</li></ul><ul><li>Marketing Language. It is important to remember that a De Novo request is not a premarket approval (PMA) and is not subject to the same approval requirements as in a PMA. The FDA recommended De Novo marketing language includes “granted De Novo,” “De Novo is granted,” or “granted marketing authorization.” Similar to other non-PMA devices, the FDA does not recommend “FDA approved” for De Novo devices. </li></ul>

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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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De Novo Classification Final Rule to Take Effect Next Year

De Novo Classification Final Rule to Take Effect Next Year

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On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the final rule, Medical Device De Novo Classification Pro

On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As we reported in an earlier <a href="https://lifesciences.mofo.com/topics/CMS-proposes-to-repeal-MCIT-final-rule.html" target="_blank">blog post</a>, CMS first proposed to repeal the MCIT/R&N in September 2021. The Final Rule was issued after a 30-day public comment period.We note that CMS received over 100 comments. Not all commenters agreed with CMS’s decision – some argued that repealing the MCIT/R&N would endanger patients, while others argued that CMS can address any outstanding issues through subsequent proposed rules. However, most comments echoed CMS’s concerns that FDA safety and effectiveness standards alone are not sufficient to meet the statutory requirements for Medicare coverage, which require that a device be reasonable and necessary for the treatment of the patient. Additionally, multiple stakeholders agreed with CMS that open-ended coverage as outlined by MCIT would harm Medicare beneficiaries, who are often older and underrepresented in clinical studies. The comments also cautioned that the MCIT pathway could potentially give an unfair advantage to breakthrough devices and stifle competition by overlooking second-to-market and non-breakthrough technologies.The repeal of the MCIT/R&N in the Final Rule does not mark the end of CMS seeking to provide coverage pathways for innovative and beneficial technologies. Rather, CMS seeks to open dialogue with the FDA, medical device manufacturers, and other stakeholders to develop a holistic approach that does not undermine Medicare beneficiary safety concerns. CMS and the Agency for Healthcare Research and Quality (AHRQ) will review the current Coverage with Evidence Development (CED) study criteria and determine whether they can update the criteria to provide advanced technology to Medicare beneficiaries without overlooking safety concerns that are unique to these patient populations. CMS welcomes dialogue from all interested parties and will hold at least two stakeholder meetings during 2022 to inform its decision-making process. Lastly, CMS encouraged informal engagement with the agency to inform the agency’s development of alternative expedited coverage pathways.Meanwhile, CMS noted in the Final Rule that coverage for innovative technologies remains possible through claim-by-claim adjudication, local coverage determinations (LCDs), and national coverage determinations (NCDs), including plans to expedite the NCD process. In addition, the 21st Century Cures Act (“Cures 2.0 Act”) draft, which builds on White House infrastructure goals to improve health care, may provide CMS with new statutory authority to provide coverage for breakthrough devices. We will continue to monitor developments in this space.

Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage

On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Def

Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage

On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations for LDTs during the COVID-19 pandemic. In withdrawing this policy, HHS said that it “no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area.”Morrison & Foerster's FDA Regulatory and Compliance team has closely followed developments related to LDTs and Emergency Use Authorizations during the pandemic. To help developers and industry understand the implications of this policy change, Brigid Bondoc, Of Counsel in Washington, D.C. moderated a discussion featuring our FDA Regulatory and Compliance co-chairs Stacy Cline Amin, former FDA Chief Counsel and Partner in Washington, D.C., and Bethany Hills, Partner in New York. Both Stacy and Bethany provided their unique insight and perspective that can be viewed below.<div class="videoWrapper" style="margin-bottom: 1.25em;"><iframe allowfullscreen="1" width="560" height="315" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" frameborder="0" title="HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests - YouTube" src="https://www.youtube-nocookie.com/embed/zDdAx65AMuU?rel=0" style="width: 560%; height: 315;" title="iframe"></iframe></div>What did HHS announce this week?HHS reversed a policy issued in August 2020 prohibiting FDA from requiring premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations for LDTs during the COVID-19 pandemic. On November 15, 2021, HHS withdrew this policy and said that it “no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area.”The longstanding approach references FDA’s longstanding view that LDTs are subject to FDA’s jurisdiction as medical devices, like any other in vitro diagnostic test, though FDA has a long history of mostly exercising enforcement discretion with respect to the premarket review requirements for LDTs.FDA followed up on the HHS announcement with a new guidance on COVID-19 testing. What are the key points of the new policy?FDA withdrew the “notification” and other policies issued in the early days of the pandemic that provided flexibility for certain LDTs and serology tests to market tests without an EUA. FDA will now require an EUA to market these tests, and if an EUA request has not already been submitted, developers have 60 days from the date of the guidance to submit an EUA request.How will FDA prioritize those tests?FDA has articulated clear and specific priorities for tests that it will review:<ul><li>Diagnostic tests (molecular and antigen) that can be used at the POC or completely at home and able to be used on symptomatic and nonsymptomatic;</li><li>Laboratory-based molecular diagnostic tests that are highly sensitive, high throughput, intended for pooling, home specimen collection, screening, or detection of multiple analytes, and from experienced developers (i.e. developers who have already received an EUA); </li><li>Home specimen collection kits intended for use with laboratory-based molecular diagnostic tests; and </li><li>Serology tests intended for quantitative measurement of antibody titers or qualitative detection of neutralizing antibodies.</li></ul>For all of these categories of tests, FDA only intends to review tests from developers who have indicated the ability to scale up manufacturing capacity of ≥500,000 tests per week within 3 months of authorization.What does this mean for tests that do not have the capacity for over 500,000 tests per week or otherwise do not fall into a prioritized category?FDA has indicated in the guidance that developers can make an argument to FDA as to why their test should be reviewed and authorized even though it does not meet the conditions for prioritization, or they can seek premarket review through the 510K or de novo pathways.However, if FDA notifies a developer that it declines to issue an EUA, the developer has 15 calendar days from the date of notification to stop marketing the test or risk enforcement action from FDA. It is not clear at this point in time how many tests will need to withdraw from the market, but we expect that many tests will be affected.What does this mean for non-COVID-19 LDTs?FDA’s more recent history with LDTs over the last 10 years indicates a concern about the safety and efficacy of the growing market, and a willingness to take compliance action and potentially even enforcement action against LDTs that it believes pose a public health risk. Moreover, its experience regulating COVID-19 tests may indicate the agency will increase its oversight of LDTs.The state of uncertainty over the last decade has led many to support a legislative solution that would provide a risk-based framework for the regulation of LDTs that would ensure safety and efficacy of diagnostic testing while continuing to promote innovation. In particular, many are closely watching the VALID Act.The Medical Device User Fee Amendments provide a must-pass legislative vehicle that may provide the perfect timing for diagnostics reform in 2022.

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HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

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On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug 

HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health.” The panel featured Bakul Patel - Director of CDRH Digital Health Center of Excellence, Zachary Henderson - Head of Legal at Levels Health, and Diane Johnson - Senior Director of Strategic Regulatory, MD&D at Johnson & Johnson.  Shelby Buettner, Principal Legal Counsel at Medtronic, moderated the panel discussion.Below are three key takeaways from the panel discussion:<ol><li>Intentionality of Functionality. This is a key concept in the development of digital health products. Panelists discussed the importance of intentionality in creating and developing products in the digital health space, and the need to understand how the inclusion of or change to some functionalities may impact the level of regulatory oversight. Bakul Patel, Director of the Digital Health Center of Excellence, emphasized the importance of breaking down and parsing out the different functionalities of a digital health software product, especially in communications with FDA, to effectively evaluate if and how the product may fall within FDA’s regulatory purview. </li><li>Early Communications. Panelists discussed how much information should be provided to FDA in early communications and what level of detail is actually helpful in early stages. Bakul Patel noted that manufacturers should strike a balance, providing more than just an idea but not too much information. Ideally, FDA would like companies to read the applicable FDA guidance and come to FDA with specific questions about how the guidance applies to them.</li><li>Development of Guidances. FDA has announced its intention to publish guidance on marketing submission recommendations for change control plans for AI/ML device software function in 2022. In addition, FDA’s final report on the <a href="https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program">Digital Health Software Precertification Pilot Program</a> is expected to be published soon outlining key learnings from the pilot. Examples in FDA guidance have great utility and FDA is continuing to figure out ways to craft helpful examples that provide enough detail without losing applicability across various stakeholders. FDA recognizes the usefulness of examples in guidance documents and notes that interactions with and feedback from industry stakeholders will be essential in continuing to provide detailed and meaningful guidance and examples for industry.</li></ol>Morrison & Foerster’s Stacy Cline Amin served on the planning committee for this conference. For questions on any of the topics discussed, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.

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Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space

Recent Digital Health-Related FDA Announcements

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FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was 

Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space