Public Health

What Med-Tech Companies Should Expect from the FDA in ‘22

The FDA’s ability to reach and sustain normal review times depends on available resources and the course of the pandemic, where the possibility of future variants remains a “wild card” and at a time when the industry is expected to launch fewer products.

COVID-19 will remain a top priority of the Food and Drug Administration throughout 2022.

“The rapid spread of the highly contagious omicron variant in December and January drove home once again the unpredictable nature of the virus,” write Ricky Zipp and Greg Slabodkin in MedTech Dive, part of a series probing industry key trends for this year.

One big prediction: Expect product review delays to remain.

The pandemic forced the FDA to prioritize coronavirus-related work while continuing to see to normal operations. This has and continues to slow product reviews. One high-profile example the writers cite is the Insulet’s Omnipod 5 insulin pump, cleared an entire year later than expected.

The FDA’s ability to reach and sustain normal review times depends on available resources and the course of the pandemic, where the possibility of future variants remains a “wild card” and at a time when the industry is expected to launch fewer products.

Enforcement and inspections will be on the rise

Med-tech companies should, however, expect the FDA to ramp up its oversight this year.

Warning letters to medical device manufacturers dropped by almost 90 percent between 2015 and 2019, according to Zipp and Slabodkin. The rate of 2020 letters was consistent with 2019.

The FDA issued 45 letters to healthcare providers in 2021, including one involving the risk of infection associated with reprocessed urological endoscopes. Experts project they will further rebound in 2022.

The administration is also “poised to ramp up for-cause and routine inspections.” The increase in enforcement and inspection can be viewed as a return to normalcy.

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