Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform.
As President-elect Joseph Biden gears up to take office on January 20, the upcoming change in administration will impact the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health. The most immediate and significant changes impacting FDA’s medical device oversight are likely to include a repeal of certain Trump administration orders on regulatory reform and changes in leadership at both FDA and the US Department of Health and Human Services (HHS). Certain FDA priorities, however, including efforts to prioritize COVID-19-related medical devices and digital health technologies, are expected to continue under the new administration. Device companies should be prepared for an uptick in FDA enforcement activity, including those that received Emergency Use Authorizations (EUAs) for products intended to aid in COVID-19 relief efforts.
Over the course of the last four years, the Trump administration has issued numerous executive orders intended to reduce federal regulation, many of which impacted FDA. For example, Executive Order 13771 required all executive departments and agencies, including FDA, to “identify at least two existing regulations to be repealed” whenever the department or agency proposed a new regulation via notice-and-comment rulemaking. More recently, HHS issued a proposed rule on November 4, 2020, that would require the department, including FDA, to perform an assessment and review of the relevant federal regulations every 10 years, and would automatically sunset such regulations if the required assessment and/or review were not timely completed. We anticipate that the incoming Biden administration would repeal or significantly revise these orders.
As with any new administration change, the incoming Biden administration is expected to nominate a new FDA commissioner. President-elect Biden has yet to announce a pick for FDA commissioner, and it is not yet clear how quickly he intends to announce a pick to replace current FDA Commissioner Dr. Stephen Hahn.
Among the names rumored as potential nominees are Dr. Amy Abernethy, Dr. David Kessler, and Dr. Joshua Sharfstein. Dr. Abernethy, a hematologist/oncologist and palliative medicine physician, is currently serving at FDA as Principal Deputy Commissioner and Chief Information Officer under Dr. Hahn. Dr. Kessler previously served as FDA Commissioner from 1990 to 1997 and is a co-chair on President-elect Biden’s COVID-19 Advisory Board. Dr. Sharfstein is currently the Vice Dean for Public Health Practice and Community Engagement at Johns Hopkins, and he previously served as Principal Deputy Commissioner at FDA during the Obama administration, under then Commissioner Dr. Margaret Hamburg. Dr. Sharfstein’s tenure at FDA overlapped with a particularly difficult time for the Center for Devices and Radiological Health (CDRH), during which CDRH faced significant scrutiny regarding the clearance of the ReGen Biologics’ Menaflex device, leading to both an internal FDA review and an outside independent review by the Institute of Medicine of FDA’s 510(k) program.
Notwithstanding a change in leadership, FDA is expected to continue to prioritize and dedicate significant resources toward its review and oversight of COVID-19-related devices, including SARS-CoV-2 tests and personal protective equipment. As described in our recent LawFlash, FDA closed out 2020 by issuing multiple new EUAs for at-home COVID-19 tests and at-home sample collection devices, including new over-the-counter options.
Since the start of the pandemic, FDA has issued numerous guidance documents setting forth enforcement discretion policies to reduce the burdens for, and increase access to, devices intended for pandemic-related uses. These priorities and policies are expected to continue under the new administration.
After a 90% decrease in Warning Letters between 2015 and 2019, coupled with a pause/significant reduction of FDA’s inspection program due to COVID-19, we anticipate an increase in FDA enforcement activity under the Biden administration. Noncompliant activity that would be handled through nonpublic, informal correspondence under the Trump administration could likely trigger formal public enforcement actions (e.g., Warning Letters, Consent Decrees) under the Biden administration.
In the near term, we expect FDA to focus its efforts on evaluating companies for compliance with their EUA Conditions of Authorization (e.g., reporting Medical Device Reports (MDRs) in accordance with 21 C.F.R. Part 803, reporting product performance issues as required by the Conditions of Authorization). In the long term, with seasoned device companies opting to participate in the voluntary third-party Medical Device Single Audit Program (MDSAP), we expect FDA’s inspection cadre (which has not reduced in size) to inspect promptly new firms that recently received premarket clearance (and potentially firms marketing 510(k)-exempt devices).
Similar to what we saw under the Obama administration, we expect an increase in “for cause” inspections triggered by allegations of wrongdoing by consumers and consumer groups to FDA. Finally, in 2021 FDA is expected to release the long-awaited publication of the revised Quality System Regulation (QSR, 21 C.F.R. Part 820) that is intended to “align” with ISO 13485:2016. There will likely be a number of questions concerning implementation of the revised QSR that will be subject to evaluation in FDA inspections.
FDA’s policies regarding laboratory developed tests (LDTs) may further evolve under the Biden administration. Historically, FDA has opted not to actively regulate most LDTs under a policy of enforcement discretion. However, FDA has reserved the right to regulate certain LDTs should FDA determine such oversight is necessary to protect the public health.
For example, in response to the COVID-19 pandemic, FDA required premarket review of LDTs intended for SARS-CoV-2 testing via the EUA pathway. However, as described in our prior LawFlash, HHS issued a statement in August 2020 to limit FDA’s oversight of LDTs. HHS subsequently clarified in an FAQ document that this policy applies to all LDTs, whether or not such LDTs are related to SARS-CoV-2 or other pandemic-related purposes. As a result, FDA announced in October 2020 that it would halt its review of EUAs for COVID-19 LDTs.
Under a Biden administration, we anticipate that HHS’s attempts to limit FDA’s policies and oversight of LDTs will subside. It remains to be seen, however, whether the new administration would support legislative changes to more clearly bring LDTs within FDA’s regulatory purview. For example, proposed legislation was introduced in March 2020 in both the House and Senate to create a new FDA regulatory scheme for all in vitro diagnostic tests, including LDTs: the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. It is not clear, however, whether the proposed VALID Act would have support with the changes in administration and in Congress.
During the Trump administration, FDA continued to move forward in developing new guidance documents and policies for digital health, including guidance documents to implement the software exemptions under the 2016 21st Century Cures Act and COVID-19 digital health guidance documents. In addition, FDA continued to move forward with its pilot program for Software Precertification and established a new Digital Health Center of Excellence.
However, FDA has yet to issue its much-anticipated final guidance for Clinical Decision Support (CDS) software, after revamping its draft CDS guidance in September 2019. FDA also has not yet finalized its updated guidance document on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued in draft format in October 2018). We expect FDA’s efforts on these digital health issues to continue under the incoming Biden administration.
Morgan Lewis helps companies around the world and across industries assess the impact of the legal and regulatory issues described above. We have assisted numerous clients with navigating FDA policies and guidance related to medical device and digital health products, both before and during the COVID-19 pandemic, including support for evaluating how or whether such technologies are regulated by FDA, the preparation and submission of EUAs, and other premarket submissions. We also counsel companies on postmarket compliance, including the development of quality system procedures and the preparation/defense of companies before FDA inspections.
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