FDA Specifies When Existing Devices Need New 510(k) Process

A new FDA draft guidance specifies what kinds of changes in existing medical devices would require new 510(k) submissions, according to an FDA release.

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By: Staff

 

For example, changes in device features, such as labeling, manufacturing and materials, may require new 510(k) submissions.

 

The document, “Deciding When to Submit a 510(k) for a Change to an Existing 510(k),” replaces a 1997 guidance of the same name.

 

Read the FDA release on changes in devices that require 510(k) submissions.

 

Read the draft guidance.

 

Related Articles on the FDA Device Approval Process:

Journal Editors Blast Studies Used by Critics of FDA Device Process

https://www.beckersasc.com/asc-supply-chain-materials-management/journal-editors-blast-studies-used-by-critics-of-fda-device-process.html

House Committee Chair Accuses FDA of Overregulating Devices

https://www.beckersasc.com/asc-supply-chain-materials-management/house-committee-chair-accuses-fda-of-overregulating-devices.html

Devicemakers Ask Congress to Ease Regulatory Burdens on Industry

https://www.beckersasc.com/asc-supply-chain-materials-management/devicemakers-ask-congress-to-ease-regulatory-burdens-on-industry.html

 

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