FEDERALhearing transcript

Congressional Hearing on FDA Medical Device User Fee Program

Original title: EXAMINING FDA'S MEDICAL DEVICE USER FEE PROGRAM

January 1, 2018

FDA Medical Devices User Fees Healthcare Regulation Congressional Oversight

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The Frame

What this does

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 is mentioned in the record

Potentially affected actors named in the source documents. Mention is not a position.

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.

What changed

Last recorded activity January 1, 2018.

What's next

Next step not available in the current record.

Summary

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.

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.
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

What is the Medical Device User Fee Program?

It is a program where medical device companies pay fees to the FDA to help fund the agency's review process for new medical device applications.

Why was this hearing held?

To conduct oversight of the FDA's performance and to gather information for the reauthorization of the .

Why It Matters

News Coverage

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Discoveries

Patterns POLISCOPE noticed across the record. These are observations to investigate, not conclusions.

cross reference100% confidence

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.

Jeffrey Shuren Cynthia A. Bens Patrick Daly

Connected Entities

personPatrick Daly“President and CEO, Cohera Medical”Map →

personDiane Wurzburger“Executive of Regulatory Affairs, GE Healthcare”Map →

personRobert Kieval“Founder and CEO, CVRx”Map →

personMichael C. Burgess“Chairman of the Subcommittee on Health”Map →

personCynthia A. Bens“Vice President of Public Policy, Alliance for Aging Research”Map →

organizationFood and Drug Administration“Federal agency responsible for medical device regulation”Map →

personJeffrey Shuren“Director, Center for Devices and Radiological Health, FDA”Map →

Sources

Open source document

www.govinfo.gov

Analysis Score

0–100

Significance60
How much this matters to a regular citizen
Controversy20
Intensity of disagreement among stakeholders
Entertainment5
Compellingness for a non-policy-wonk reader
Buzz10
Current news / social attention level

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