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To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.

1/11/2023, 1:31 PM

Congressional Summary of HR 2424

This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process.

When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.

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Current Status of Bill HR 2424

Bill HR 2424 is currently in the status of Bill Introduced since May 19, 2015. Bill HR 2424 was introduced during Congress 114 and was introduced to the House on May 19, 2015.  Bill HR 2424's most recent activity was Referred to the Subcommittee on Health. as of May 22, 2015

Bipartisan Support of Bill HR 2424

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
0
Democrat Cosponsors
0
Republican Cosponsors
0
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 2424

Primary Policy Focus

Health

Potential Impact Areas

- Administrative law and regulatory procedures
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Food and Drug Administration (FDA)
- Government employee pay, benefits, personnel management
- Government studies and investigations
- Health technology, devices, supplies
- Product safety and quality

Alternate Title(s) of Bill HR 2424

To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.
To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.

Comments

Sponsors and Cosponsors of HR 2424

John Shimkus
John Shimkus
IllinoisRepublican

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