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United States laws under review

M Leahey1

  • 1Medical Device Manufacturers Association, Washington, District of Columbia 20005, USA. mleahey@medicaldevices.org

Medical Device Technology
|June 26, 2007
PubMed

Insights

Congress is considering reauthorizing the Medical Device User Fee and Modernization Act. Additionally, new incentives for developing pediatric medical devices are under review.

Area of Science:

  • Medical device regulation
  • Pediatric healthcare innovation

Background:

  • The Medical Device User Fee and Modernization Act (MDUFMA) is up for reauthorization.
  • There is a recognized need for medical devices specifically designed for pediatric populations.

Purpose of the Study:

  • To inform stakeholders about legislative activities concerning medical device regulation.
  • To highlight the potential introduction of incentives for pediatric medical device development.

Main Methods:

  • Legislative review and analysis.
  • Policy discussion summary.

Main Results:

  • Reauthorization of MDUFMA is a key legislative focus.
  • Incentives for pediatric medical device development are being considered.

Conclusions:

  • Congressional action is anticipated regarding medical device user fees.
  • Policy changes may encourage the creation of novel pediatric medical devices.

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