To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment.
Do you support it?
Want to know if it passes?
We'll email you when HR 2422 moves — a committee vote, a floor vote, or a signature. Nothing else.
Free forever · unsubscribe in one click.
Your answer was recorded either way.
Which district are you in?
Your ZIP is all we need to match you to your own representatives — so we can tell you how they voted on HR 2422.
You're tracking HR 2422
We'll email you the moment it moves.
HR 2422 — To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment.
Last action — Referred to the Subcommittee on Health.
No card. One bill, free forever — alerts when it moves.
-
✓Introduced
-
✓In Committee
-
Died in session
This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.
Summary
To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers are allowed to make changes to a device without submitting to the FDA the 30-day notice required for manufacturing changes or a premarket approval supplement if their quality system has been certified by an accredited person. An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified. Periodic reports by device manufacturers must describe any changes made to a device without submission of the 30-day notice or the premarket approval supplement. Certifications accepted by the FDA remain in effect for two years. The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.
Bill Text
We don't have the full text on file for this bill yet.
Read HR 2422 on the official United States source →Action History
-
Referred to the Subcommittee on Health.
-
Referred to the House Committee on Energy and Commerce.
-
Introduced in House
Sponsors
- John Shimkus · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 0 co-sponsors · 546 not signed on
Sponsors (1)
Co-sponsors (0)
None.
Not signed on (546)
546 members have not signed on to this bill.
Show all 546 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Subjects
Frequently asked questions
- What does HR 2422 do?
- To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers are allowed to make changes to a device without submitting to the FDA the 30-day notice required for manufacturing changes or a premarket approval supplement if their quality system has been certified by an accredited person. An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified. Periodic reports by device manufacturers must describe any changes made to a device without submission of the 30-day notice or the premarket approval supplement. Certifications accepted by the FDA remain in effect for two years. The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.
- Who sponsors HR 2422?
- HR 2422 is sponsored by John Shimkus (R).
- What is the current status of HR 2422?
- This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
- Where can I track HR 2422?
- Track HR 2422 free on One Click Politics — get push/email alerts when it moves.
Make your voice heard on HR 2422
Find the representatives who decide this bill and tell them where you stand — for yourself, or mobilize your whole list in one click with One Click Politics advocacy software.
Stay ahead of HR 2422
Last checked for changes about 14 hours ago · updated continuously
One Click Politics tracks every bill in Congress and all 50 states.
Track this bill →