FEDERALhearing transcript

Congressional Hearing on Medical Technology Regulation

Original title: EXAMINING IMPROVEMENTS TO THE REGULATION OF MEDICAL TECHNOLOGIES

January 1, 2018

medical technology FDA regulation health care medical devices hearing health

Track this bill to get notified when it advances a stage. One tap to stop, anytime.

The Frame

What this does

The hearing explores potential changes to how the FDA oversees medical devices, which directly impacts the safety, cost, and availability of medical equipment for patients and healthcare providers.

Who is mentioned in the record

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

Medical device manufacturers

These companies are subject to FDA regulatory oversight and compliance requirements for their products.

Patients

Patients rely on the safety and efficacy of regulated medical devices for their healthcare needs.

Medical equipment servicers

These entities are involved in the maintenance and remarketing of medical equipment, which is subject to regulatory scrutiny.

What changed

Last recorded activity January 1, 2018.

What's next

Next step not available in the current record.

Summary

This document is a transcript of a May 2, 2017, House Subcommittee on Health hearing regarding the regulation of medical technologies. The session featured testimony from FDA officials, medical experts, and industry representatives to discuss potential improvements to the regulatory framework for medical devices.

Key Facts

The hearing was held on May 2, 2017, by the House Subcommittee on Health.
The primary focus was examining improvements to the regulation of medical technologies.
Testimony was provided by representatives from the FDA, medical academia, and the medical device industry.
The hearing included discussions on the regulatory environment for medical equipment remarketers and servicers.
Multiple organizations submitted statements for the record, including AARP, the Consumer Technology Association, and the Hearing Loss Association of America.

Why It Matters

The hearing explores potential changes to how the FDA oversees medical devices, which directly impacts the safety, cost, and availability of medical equipment for patients and healthcare providers.

Frequently Asked Questions

What was the purpose of this hearing?

The hearing was held to discuss and examine potential improvements to the regulatory processes governing medical technologies and devices.

Who testified at the hearing?

Witnesses included Dr. Jeffrey Shuren from the FDA, representatives from Philips North America and Medtronic, medical experts, and legal counsel for medical equipment servicers.

News Coverage

No news coverage found yet. Articles are indexed twice daily.

Discoveries

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

policy shift80% confidence

Focus on Hearing Health

The inclusion of multiple statements from hearing loss advocacy groups suggests a specific legislative interest in the regulation of hearing-related medical technologies at the time.

AARP Hearing Loss Association of America Academy of Doctors of Audiology

Connected Entities

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

organizationPhilips North America“Medical technology company”Map →

organizationAARP“Submitted testimony regarding hearing health”Map →

organizationFood and Drug Administration“Federal agency responsible for regulating medical devices”Map →

organizationMedtronic“Medical device manufacturer”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
Entertainment10
Compellingness for a non-policy-wonk reader
Buzz15
Current news / social attention level

Publisher tools