Lauded By Industry, Loathed By FDA? New HHS ‘Good Guidance’ Rule Likely Ruffling Feathers
A Good Guidance Practices regulation from the US HHS, pushed through the rulemaking process in the waning days of the Trump administration, will likely delight the medtech industry and be pushed back on by the FDA, experts tell Medtech Insight.
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Expiration dates in HHS’ final SUNSET rule exclude OTC drugs after CCHPA and other groups argue the rule would create more problems than it would solve. But dietary supplement regulations are subject to the rule.
The rule would mandate that agencies assess rules that affect small entities once every decade to ensure they were still appropriate.
'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.