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United States laws under review
1Medical Device Manufacturers Association, Washington, District of Columbia 20005, USA. mleahey@medicaldevices.org
Medical Device Technology
|June 26, 2007
Summary
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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