HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Lauded By Industry, Loathed By FDA? New HHS ‘Good Guidance’ Rule Likely Ruffling Feathers

Executive Summary

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.

You may also be interested in...



US Regulatory SUNSET Misses FDA’s OTC Drug Regulations, But Reaches Supplement Rules

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.

Most Regs Would Get 10-Year Reviews Under HHS Proposal

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.

Topics

UsernamePublicRestriction

Register

OM011381

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel