MedTech Dive June 9, 2022
Elise Reuter

Dive Brief:

  • The House of Representatives passed legislation late Wednesday to reauthorize the Food and Drug Administration user-fee amendments for five more years. 
  • The House version of the bill includes provisions that would require drug and device manufacturers to develop a plan for clinical trial diversity early in the development process, which they would submit to the FDA. It also would bolster cybersecurity requirements for medical devices.
  • The Senate Committee on Health, Education, Labor and Pensions (HELP) is expected to work on its version of the bill, which includes an overhaul of how diagnostics are regulated, next Tuesday.

Dive Insight:

By a 392-28 vote, the House passed legislation that would reauthorize the FDA’s user-fee programs for medical devices...

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Oliver Wyman
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Oliver Wyman

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Topics: Clinical Trials, Congress / White House, Cybersecurity, FDA, Govt Agencies, Health IT, Medical Devices, Regulations, Technology, Trends
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