Foggy On The Details: FDA Looks To OMB For 'Clarity' On What Constitutes A 'Major' Guidance Or Rule
In mid-May a policy will kick in that requires all US agencies to send new rules and guidance documents to the Office of Management and Budget so it can determine whether they're "major" and should be voted on by Congress. Yet an FDA official said at MedCon 2019 on 2 May that the agency is still looking for more "clarity" on the subject. There are several draft guidances in the device center pipeline that will be affected by the OMB's oversight play.
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Speaking at MedCon 2019, CDRH Director Jeff Shuren announced 1 May is officially the first day for the agency’s new Office of Product Evaluation and Quality. The agency lists several examples of how it has already been used in a pilot setting to remove potentially harmful products from market sooner, and resulted in more efficient and safer product reviews.
'Major' Pain For FDA: Under OMB Directive, Congress Will Vote On So-Called 'Major' Rules, Guidance Docs
New regulations and guidance documents from the US FDA will soon have to undergo scrutiny from the Office of Management and Budget to determine whether they're "major" and should therefore be reviewed and approved by Congress. The direction from OMB acting Director Russell Vought in an April 11 memo will undoubtedly delight some in the medical device industry who have complained for years that the FDA uses voluntary guidance documents to actively drive regulatory decisions.
A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.