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Read. Follow. Verify.Congressional Hearing on FDA Medical Device User Fee Program
Record date · January 1, 2018
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What This Bill Does
The House Subcommittee on Health held a hearing on March 28, 2017, to review the FDA's Medical Device . The session featured testimony from FDA officials, medical device industry representatives, and patient advocacy groups regarding the program's performance and future reauthorization.
This hearing serves as the legislative oversight process for the Medical Device User Fee Amendments (), which determine how the FDA funds the review and approval process for new medical devices, directly impacting the speed at which new medical technologies reach the market.
Who It Affects
Groups the bill's text affects, as described in the record. Being affected is not a position for or against it.
Medical Device Manufacturers
These companies pay user fees to the FDA and are subject to the agency's review timelines for product approval.
FDA
The agency receives and manages user fee funding to support its regulatory review operations.
Patients
Patients rely on the FDA's review process to ensure the safety and efficacy of medical devices before they enter the market.
Key Facts
- The hearing was held on March 28, 2017, by the House Subcommittee on Health.
- The primary subject was the examination of the FDA's Medical Device User Fee Program.
- Witnesses included representatives from the FDA, the Alliance for Aging Research, CVRx, Cohera Medical, and GE Healthcare.
- The hearing record includes prepared statements from all witnesses and committee members.
Show all 5 facts
- Dr. Jeffrey Shuren, Cynthia A. Bens, and Patrick Daly did not provide answers to submitted questions for the record by the time of printing.
Frequently Asked Questions
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News Coverage
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Votes, people, money & the original sourceFull breakdown
Who this bill affects and the strongest case for and against it, written only from the bill’s own text.
Discoveries
Patterns POLISCOPE noticed across the record. These are observations to investigate, not conclusions.
Unanswered Questions
The document explicitly notes that several key witnesses failed to provide answers to submitted questions for the record by the time of printing.
Connected Entities
Sources
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Analysis Score
0–100- Significance60How much this matters to a regular citizen
- Controversy20Intensity of disagreement among stakeholders
- Entertainment5Compellingness for a non-policy-wonk reader
- Buzz10Current news / social attention level
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