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Trump's Two-For-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say

Executive Summary

For the most part, industry experts and lobbyists say they still have questions about President Trump's latest executive order, which requires agencies to rescind two regulations for every one rule that is implemented. With key leadership positions at HHS and FDA still unfilled, some say they are taking a wait-and-see approach before concluding how the order will be interpreted.

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In mid-May a policy will kick in that requires all US agencies to send new rules and guidance documents to the Office of Management and Budget so it can determine whether they're "major" and should be voted on by Congress. Yet an FDA official said at MedCon 2019 on 2 May that the agency is still looking for more "clarity" on the subject. There are several draft guidances in the device center pipeline that will be affected by the OMB's oversight play.

'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.

OMB: US FDA Has Withdrawn At least 10 Regulations In Response To Trump 2-for-1 Order

Following several executive orders from the president intended to remove regulations from the federal books, the White House tells Medtech Insight it has already pulled multiple rules from FDA and other agencies – and that number may still grow by the time the Office of Management and Budget has completed an agency-wide review.

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