Devices

FDA 2020 Device Law and Policy Activities Analyzed

David McFarland

— 2 min read
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Attorneys Aaron Josephson and Benjamin Zegarelli (Mintz) say in an online post that 2020 was the year that Americans became familiar with lesser-known and niche FDA policies like those governing emergency use authorizations, and with the agency role in regulating laboratory-developed tests. The two use this post to explore FDA’s device law and policy activities from 2020 in several key areas: 

  •          Covid-19 Diagnostics – Initially, the attorneys write, the agency received mostly negative attention for well-documented missteps relating to testing. Since then, they say, there has been a significant increase in the number of tests authorized for point-of-care use in patient-care settings. FDA also developed a SARS-CoV-2 reference panel with a standard baseline for test kit validating testing. The authors say the question remains whether testing capacity and capabilities have advanced to the point of allowing a broad reopening of the country, and suggest that the answer is “no” due to the lack of deployment of rapid point-of-need tests that could be used at airports, stadiums, and other public venues, including workplaces.
  •          Laboratory-Developed Tests – An August HHS statement barred FDA from requiring premarket review for any laboratory-developed test (LDT), including those for Covid-19, unless the agency goes through formal rulemaking proceedings. The attorneys say that the regulatory framework and policies surrounding LDTs will be a prominent debate topic in 2021. “We expect there will be no quick resolution of these issues, either at a legislative or agency policy level, in the short term, and that LDTs will likely remain in a gray area of FDA regulation and policy for the foreseeable future,” they write.
  •          Digital Health – The agency established the Digital Health Center of Excellence that is envisioned to be a multi-Center effort for developing, coordinating, and implementing comprehensive agency-wide digital health policies and programs.
  •          510(k) and PMA Reform – The Covid-19 pandemic stalled progress on implementing changes to the 510(k) and PMA pathways proposed in 2019, the attorneys say. Two clouds looming over them now, they write, are the new administration and the question of which party will control the Senate. The post says that Senate Democrats have long been skeptical of FDA attempts to change the device regulatory model, fearing it is too industry-favored and lacks needed safety oversight. They conjecture that a new commissioner appointed by President Joe Biden may similarly be unenthusiastic about proposals that appear to make it easier to get products to market without thorough vetting.
  •          Missed Deadlines – The authors say CDRH missed some deadlines in 2020 and they express the hope that it doesn’t represent a pattern of the Center either setting goals so lofty it can’t reasonably meet them or choosing to prioritize its own goals over those set by Congress.

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