'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.