2021 LS&HC Horizons - Flipbook - Page 68
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Hogan Lovells
2021 FDA projections for the medical device industry
Many are looking at 2021 as being active for
FDA to re-focus on those items that were put
on pause due to the pandemic. Although early
priorities will focus on vaccinations and devices
still needed during a dissipating pandemic, here
are three areas that we believe FDA could make a
priority for the medical device industry.
• Increased enforcement: 2015 – 2020 has
been a period with a significant decrease
in CDRH enforcement and Warning Letter
issuance. With a new administration and
CDRH restructure now complete, the
pendulum will likely swing back with a
renewed interest on enforcement and
ensuring compliance. We could see a
repeat in the increase of inspections and
enforcement actions that was seen after
the recession in 2008/2009. FDA efforts
will likely focus on areas of highest risk,
including class III products, post-market
trends/recalls and new market entrants
that have never been inspected. Even those
participating in MDSAP could be prioritized
and inspected “for cause.”
• Border scrutiny: One of the unfortunate
results of the pandemic has been the
market flooded with inferior products.
Many fraudulent and/or otherwise illegal
products have been caught due to increased
scrutiny by U.S. Customs and FDA. With
the lessons learned during the pandemic,
increased scrutiny will likely continue
leading to increased import detentions and
possibly increases in the issuance of import
alerts.
• Regulation of LDTs: Consistent with recent
statements and policies by HHS, 2021
could be the year that FDA seeks to regulate
Laboratory Developed Tests (LDTs) through
notice-and-comment rulemaking. This
could occur without a grant of legislative
authority, which has been a barrier that has
prevented prior regulatory efforts. Despite
HHS’s recent statements indicating that
FDA has such authority, we expect to see
some back-and-forth before it is settled as
to how FDA will regulate LDTs.
Mike Heyl
Partner, Washington, D.C.
mike.heyl@hoganlovells.com
Ranked Band 1
for Healthcare and
Healthcare: Pharmaceutical/
Medical Products Regulatory
– District of Columbia
Chambers USA, 2020
