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'Major' Pain For FDA: Under OMB Directive, Congress Will Vote On So-Called 'Major' Rules, Guidance Docs

 
• By Shawn M. Schmitt

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.

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OMB says Congress must vote up or down on "major" regs and guidance docs

The US FDA will soon have to submit new regulations and guidance documents to the Office of Management and Budget so it can decide whether they meet the threshold of a so-called "major" document that must be reviewed and approved by Congress.

The plan is outlined in an April 11 memo to the heads of US agencies from OMB acting Director...

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