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Streamlining Medical Device Modifications Approval

New rules aim to simplify how manufacturers make changes to medical devices, like equipment or implants, by avoiding a lengthy approval process for each modification. This means innovations and improvements can reach patients faster, potentially leading to access to more modern and safer products. The changes are designed to accelerate access to improved medical technologies while maintaining high safety standards.
Key points
Medical device manufacturers can now pre-plan future changes to their products and get a single approval for these changes.
If changes align with the approved plan, repeated, time-consuming approvals for each modification will not be required.
This is intended to speed up the introduction of improvements and innovations in medical equipment, potentially leading to faster access to more advanced therapies for citizens.
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Additional Information
Print number: 117_HR_8299
Sponsor: Rep. Bilirakis, Gus M. [R-FL-12]
Process start date: 2022-07-07
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_HR_8299.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2022-07-07.

What are the main provisions?

Key points include:

  • Medical device manufacturers can now pre-plan future changes to their products and get a single approval for these changes.
  • If changes align with the approved plan, repeated, time-consuming approvals for each modification will not be required.
  • This is intended to speed up the introduction of improvements and innovations in medical equipment, potentially leading to faster access to more advanced therapies for citizens.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Bilirakis, Gus M. [R-FL-12].

What is the latest detailed status?

The latest detailed status is: Referred to the House Committee on Energy and Commerce.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-28.

CATEGORIES

Health