2019 FDA Warning Letters Spotlight Device Approval Gaps

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ARTICLE SUMMARY:

The number of warning letters sent to device companies by FDA have nose-dived, but citations addressing lapses in pre-market approvals or clearances for marketed products remained relatively robust last year. Here’s a look at some key 2019 warning letter trends.

In the device world, FDA warning letters are primarily viewed as formal enforcement tools to address lapses in a company’s manufacturing and design control quality practices. But the agency can also use the letters to target gaps in pre-market approvals and clearances. That latter focus was on clear display in 2019, which included the largest proportion of “pre-market”-focused device warning letters in the past five years, according to a review by Market Pathways.

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