Industry: FDA Recalls v. Enhancements Guidance Is Overreaching, Confusing

A recent FDA draft guidance on distinguishing product recalls from product enhancements has met strong industry resistance, with many commenters asking the agency to withdraw the guidance and try again.

The draft was issued in February to address what agency officials said was ongoing confusion over when a product change needs to be reported as a recall. The comment period for the guidance closed May 23, and 19 comments were posted to a government website.

Summing up industry concerns, AdvaMed says the guidance, as proposed, “will not promote the public health, will undermine Quality System Regulation policies, will be a drain on agency and industry resources and will potentially add confusion to the premarket evaluation process, leading to delays in getting safer and more effective products to market.”

Industry’s primary complaint is that the draft seems to broaden the range of modifications that need to be reported to the FDA to those made before a device leaves the factory and corrections that do not affect safety. However, current law requires only the reporting of recalls of products in the distribution chain, several commenters said. That means that, in attempting to regulate products that have not yet been distributed, the draft represents an overreach of agency authority, AdvaMed says.

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