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United States

Set Alert for Policy and Regulation United States

Quality, Safety, MDSAP A Focus For Medtech In New USMCA Trade Agreement

The new US-Mexico-Canada (USMCA) trade agreement includes language on enhancing regulatory compatibility between the three countries by recognizing quality systems audits performed under the Medical Device Single Audit Program (MDSAP). It also stipulates that each trading partner “consider its resources and technical capacity” in ensuring the safety, effectiveness and quality of devices – and more. Medtech industry advocacy group AdvaMed is praising the deal, reached by the three countries on 10 December.

Trade Policy Quality

Latest From United States, Policy & Regulation

Radiation Oncologist Stephen Hahn Wins Final Senate Confirmation As FDA Commissioner

The US Senate on a 72-18 vote approved radiation oncologist Stephen Hahn as Commissioner of the FDA on 12 December. Voting “no” were a block of liberal Democrats, including the ranking member of a key Senate health committee. Industry advocates and most senators said Hahn is an excellent choice to lead the FDA, but some fear he will not move quickly enough to ban candy flavors in vaping products favored by teens.

Policy Leadership

FDA Gives Sponsors A New Tool To Prove MRI-Compatibility

The US FDA has qualified a new modeling tool that could give sponsors more assurance that their products meet the agency’s expectations for MRI-compatibility.

Regulation Review Pathway

FDA Commissioner Nominee Hahn Advances To Full Senate, Despite Some Dems’ Reservations

Stephen Hahn, the Trump administration’s nominee to lead the US FDA, has been approved by the Senate Health, Education, Labor and Pensions (HELP) Committee, with some “no votes” from Democratic senators in leadership positions, and is expected to be considered by the full Senate this week.

Policy Legislation

FDA Holding February Public Meeting On Using AI In Radiology

The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.

Regulation Artificial Intelligence

Performance Criteria Issued On Magnetic Resonance Coils In New FDA Draft Guidance

Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.

United States Medical Device

Cybersecurity: Guidance Docs To Come, But Legacy Devices Still A Challenge

Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.

Cybersecurity Regulation
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