'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.

Two hands showing different gestures. Thumb up and thumb down, black and white -
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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

More from Policy & Regulation

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.

Global Medtech Guidance Tracker: May 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.