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

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

In an interview with Sabine Wadewitz, life sciences expert Wolfgang Schönig talks about the details of CO²-neutral meat production, the legal framework conditions, and the latest developments in the industry.Excerpt below. _____________________________________________Dr. Schönig, CO2-neutral meat production is considered one of the key aspects in the fight against climate change. Can we really make a big difference through our food choices?According to expert estimates, conventional meat production takes up around 75% of the agricultural land used worldwide and is responsible for over 15% of the greenhouse gases emitted globally. This is a rising trend. Alternatives, such as plant-based meat substitutes or meat produced in cell cultures, are significantly more resource-conserving and climate-friendly by comparison, mainly because no greenhouse gases are produced, and the high water and energy consumption of conventional animal husbandry is eliminated. For the agri food industry, this is not so much an option, it’s a necessity, as the industry will have to meet strict CO2 reduction requirements by 2030 as part of the EU’s so-called Green Deal.How often does environmentally friendly meat end up on your plate?The market for meat substitutes is growing rapidly, and this is happening without strict regulatory requirements for the industry in terms of the CO2 reductions already in place. The market here probably anticipates the compelling need and sees the opportunities – both for plant based alternatives and for cell-cultured meat. It is important to remember that the world’s population will grow to nearly 10 billion by 2050, all of whom will need sufficient protein foods. So it's not so much a lifestyle choice, but an essential contribution to curb CO2 emissions and preserve our lives. It also presents immense economic opportunities.

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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“At any rate, it won’t fail because of money.”

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In an interview with Sabine Wadewitz, life sciences expert Wolfgang Schönig talks about the details of CO²-neutral meat production, the legal framework conditio

“At any rate, it won’t fail because of money.”

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.

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

Is 2021 the Value-Based and Shared Savings Revolution?

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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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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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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

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.

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

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

This article follows our introduction to the alternative protein industry and the legal considerations for companies and investors operating within it. The focus of this article is on the regulation of insects as food and feed in the European Union (“EU”), United Kingdom (“UK”), U.S., and Singapore.Read the <a href="https://www.mofo.com/resources/insights/211028-alternative-protein-industry-series" target="_self">full client alert</a>.