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

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California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Privacy Act (GIPA) became the latest state genetic data privacy law to go into effect, adding to a growing number of state laws that require special protections for genetic data. This new law, signed by California Governor Gavin Newsom on October 6, 2021, impacts direct-to-consumer (DTC) genetic testing companies as well as service providers to those companies. Read our <a href="https://www.mofo.com/resources/insights/220118-latest-genetic-data-privacy-law.html?utm_source=publication&utm_medium=email" target="_blank">client alert.</a>

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Melissa Crespo helps clients navigate a wide range of challenging privacy compliance and data security matters with a focus on the health information and the health care sector.

Melissa M. Crespo

Melissa Crespo

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Latest Genetic Data Privacy Law Goes into Effect

Latest Genetic Data Privacy Law Goes into Effect

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California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Priva

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

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

FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework.  In 2021, FDA published the <a href="https://www.fda.gov/media/145022/download" target="_blank">AI and Machine Learning Software as a Medical Device Action Plan</a>, which outlines FDA’s approach to regulating AI/ML technologies and next steps in furthering oversight, as well as the <a href="https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles" target="_blank">Good Machine Learning Practice for Medical Device Development: Guiding Principles</a>, to inform the development of Good Machine Learning Practice.  FDA also released a <a href="https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices" target="_blank">database</a> of AI/ML-enabled medical devices currently marketed in the United States and will update this list as FDA reviews and authorizes additional AI/ML-enabled medical devices going forward. <a href="https://mofotech.mofo.com/topics/ai-trends-2022-fda.html" target="_self">Read more</a>.

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AI TRENDS FOR 2022 - FDA REGULATORY

Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

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FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps 

AI TRENDS FOR 2022 - FDA REGULATORY

The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference.  Stacy Cline Amin, who served on the conference planning committee, moderated a panel discussion on congressional perspectives and considerations in the digital health space. Bethany Hills participated on a panel discussion on evolutions in telehealth regulation and reimbursement, with a focus on recent developments in 2021. Below are key topics and takeaways discussed during the panels.<h4>Congressional Perspectives in Digital Health</h4>This panel featured senior staff from both of the FDA’s committees of jurisdiction, the Senate Health Committee and the Senate Finance Committee, the House Energy & Commerce Committee, as well as senior staff who led the negotiations for the 21st Century Cures Act.<ol><li>At the time the 21st Century Cures Act was drafted and negotiated, Congress had in mind smart watches and similar digital health technology that is far less complicated than the realities of the technology today.  The advancements and increased technological complexity have brought a slew of intricate questions about when and how FDA regulation should come into play and whether Congress should provide more clarity for the industry.  For example, how should clinical decision support be defined, and at what point should it be subjected to FDA regulatory review or approval?    </li><li>In the artificial intelligence and machine learning (AI/ML) space, panelists discussed the challenges of regulating technology that is continuously changing and the potential incompatibility of AI/ML technologies with existing regulatory frameworks, such as change protocols.  Panelists emphasized the importance of having patients and providers at the table in these ongoing discussions and ensuring that Congressional stakeholders and constituents can understand the technology and mechanics in order to make meaningful decisions. </li><li>Congress is considering these issues as part of the Medical Device User Fee Amendments. Panelists encouraged industry stakeholders and constituents to provide comments and insights to Congressional representatives and staff as these discussion continue.</li></ol><h4>Telehealth 2021:  Regulatory and Reimbursement Developments</h4><ol><li>As we begin to approach the end of the pandemic, the waivers and exemptions extended during the public health emergency have begun to be withdrawn.  Without action from Congress, most Medicare beneficiaries of telehealth will lose access to the majority of telehealth services available during the pandemic.  While many stakeholders are advocating for permanent changes to law regarding telehealth access, a simple extension of the current wavier period is more likely as a near-term action.  Of note, the Centers for Medicare and Medicaid Services (CMS) has already expanded its definition of telehealth services to include audio-only services for mental health services.  </li><li>CMS has created carve-outs for services that may not be defined exactly as telehealth services, but that are supportive of and integrated with telehealth, such as remote physiologic and therapeutic monitoring.  Changes to the RPM and RTM codes and guidelines indicate a certain degree of desired flexibility, but also come with additional questions and areas of ambiguity.  </li><li>Digital health companies are taking advantage of the health insurance adoption of telehealth, maximizing the benefit of telehealth and its potential to lower costs while enhancing patient care.  However, there are a number of challenging issues going forward, particularly with digital-first health insurance offerings and direct-to-consumer (DTC) telehealth products that incorporate insurance‑like features.  In addition, many states issued waivers permitting clinicians to practice across state borders without licensure during the pandemic.  As state-level licensure waivers are winding down, this poses challenges for digital health providers in constructing and maintaining viable provider networks for insurance and DTC markets.</li></ol>For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.

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Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference

Recent Digital Health-Related FDA Announcements

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The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021. 


Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference

This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified <a href="https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles?utm_medium=email&utm_source=govdelivery&utm_source=STAT+Newsletters&utm_campaign=6a098880a8-health_tech_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-6a098880a8-153551262" target="_blank">10 guiding principles</a> to inform the development of Good Machine Learning Practice (GMLP) and promote safe and effective medical devices that use artificial intelligence and machine learning (AI/ML).  The guiding principles “identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations, and other collaborative bodies could work to advance GMLP,” including creation of educational tools and resources, international harmonization, and consensus standards.<img alt="Good Machine Learning" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt4bac1f9a18159f5f/6273178d4d9f89297129022f/211101-good-machine.jpg?format=auto&quality=60" type="asset" sys-style-type="download">The guiding principles reflect some of the focus topics articulated in FDA’s <a href="https://lifesciences.mofo.com/topics/five-key-takeaways-from-FDAs-transparency-of-AIML-enabled-medical-devices-virtual-workshop.html" target="_blank">Transparency of AI/ML-Enabled Medical Devices Virtual Workshop</a>.  For example, the guiding principles recommend that “users are provided clear, essential information,” emphasizing the importance of providing clear, contextually relevant information about the device to the intended audience.  The principles also include requirements that “testing demonstrates device performance during clinically relevant conditions,” and “deployed models are monitored for performance and re-training risks are managed.”FDA welcomes feedback through the public docket at Regulations.gov (<a href="https://www.regulations.gov/docket/FDA-2019-N-1185" target="_blank">FDA-2019-N-1185</a>) and may be contacted directly at <a href="mailto:Digitalhealth@fda.hhs.gov" target="_blank">Digitalhealth@fda.hhs.gov</a>.  Health Canada and the UK’s MHRA may be contacted directly at <a href="mailto:mddpolicy-politiquesdim@hc-sc.gc.ca" target="_blank">mddpolicy-politiquesdim@hc-sc.gc.ca</a> and <a href="mailto:software@mhra.gov.uk" target="_blank">software@mhra.gov.uk</a> respectively.For questions on any of the topics discussed at this meeting, 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</a> practice.

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FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

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

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This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MH

FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices.  The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology in the medical device space, with an emphasis on information-sharing methods for patients, caregivers, and providers.Below are five key takeaways from the workshop:<ol><li>Cultivating user awareness for both patients and healthcare providers will be a key area of focus for AI/ML-enabled device manufacturers and regulators going forward.  In presentations and panel discussions, many panelists expressed concern as to whether healthcare providers would understand the limitations of AI/ML devices and be able to properly interpret and use the data in administering care.</li><li>Transparency and effective communication of AI/ML medical device labeling will be important to consider for all user types.  Panelists discussed the idea of a nutrition facts label approach to AI/ML device labeling, using the analogy of food labeling to describe the balance of information and detail needed to enable users to make informed decisions.</li><li>Bias and systemic discrimination remain persistent issues in the AI/ML space.  FDA and various industry stakeholders expressed commitment to ensuring that the data used to train AI/ML models are diverse and accurately reflect the patient population in which the technology will be used.  Use of synthetic or artificial datasets to close the data gap and ensure devices are trained using ethnically diverse datasets has been a particularly relevant discussion.</li><li>Inequality, from both a patient and a manufacturer perspective, was a key topic of conversation during the workshop.  Panelists discussed the potential for inequitable access to AI/ML devices across different patient populations, as well as the potential for unequal access to data amongst manufacturers in the industry.</li><li>Transparency surrounding tracking and reporting of device error or malfunctions will be an important topic of discussion as AI/ML-enabled devices are made available.  Panelists discussed the potential for two-way communication between manufacturers and users, and FDA’s role in promoting such transparency.</li></ol>The recording of the webcast, transcript, and presentation slides will be posted on the Workshop webpage within the next few weeks.  FDA will continue to receive and review comments and questions regarding transparency of AI/ML-enabled medical devices online on the public docket.  Comments may be submitted on <a href="https://www.regulations.gov/" target="_blank">regulations.gov</a> (Docket No. FDA-2019-N-1185) until November 15, 2021.For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s <a target="_blank" href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html">FDA Regulatory + Compliance</a> practice.

Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop

On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning 