De Novo Guidance Doesn’t Cut Review Time Enough, Industry Says

Industry is skeptical of FDA claims that the plan mapped out in a recent draft guidance on de novo petitions will speed the review process for devices that aren’t a good fit for either the 510(k) or PMA programs.

The device industry claims FDA’s de novo draft guidance won’t accomplish what the agency set out to do: speed up the review of devices that aren’t a good fit for either the 510(k) or PMA programs.

While it may take a change in law to truly address the issue, industry groups are suggesting some tweaks to...

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