FDA issues revised 510(k), PMA application guidance — 8 things to know

Spinal Tech

On Jan. 30, the FDA released two final revised medical device guidance documents entitled "Refuse to Accept Policy for 510(k)s" and "Acceptance and Filing Reviews for Premarket Approval Applications," The National Law Review reports.

Here are eight things to know:

 

1. The updates address provisions in the 21st Century Cures Act enacted on Dec. 13, 2016. The Cures Act amended Section 503(g) of the Food, Drug and Cosmetic Act and applied certain drug provisions to device-led combination products.

 

2. The 510(k) guidance includes checklists for traditional, abbreviated and special 510(k)s for FDA staff to use when determining whether to accept a 510(k) for filing.

 

3. The 510(k) checklists include five preliminary questions to be answered before the 510(k) is compared to the acceptance criteria:

 

  • Is the product a device or a combination product with a device component?
  • Is the application with the appropriate Center?
  • Is 510(k) the appropriate regulatory submission?
  • Is there a pending PMA (pre-market approval application) for the same device and indications for use?
  • If clinical studies have been submitted, is the submitter the subject of the Application Integrity Policy?

 

4. The guidance states that the acceptance review should be conducted and completed within 15 calendar days of the FDA's 510(k) receipt. If the FDA does not accept the filing, it will notify the submitter and send them a copy of the completed checklist to help identify the deficiency.

 

5. The submitter may submit the additional information identified in the checklist and the FDA will perform the acceptance screening again within 15 calendar days of receiving the information. If the FDA still refuses to accept the filing, the submitter will be notified and given the new checklist. If the FDA accepts the filing, it notifies the submitter and begins a substantive review of the 510(k).

 

6. If the FDA fails to respond within the 15 days, the 510(k) is considered to be accepted and the agency will notify the submitter and begin the substantive review.

 

7. The PMA guidance follows the same 15-day scheme as the 510(k) guidance and includes checklists for acceptance decision. The PMA checklists include five preliminary questions to be answered:

  • Is the product a device or a combination product with a device component?
  • Is the application with the appropriate center?
  • Is PMA the appropriate regulatory submission?
  • Is there a pending 510(k) for the same device and indications for use?
  • If clinical studies have been submitted, is the submitter the subject of the Application Integrity Policy? 

 

8. The FDA will not accept an incomplete PMA, a PMA when the applicant has a pending 510(k) for the same device and if it contains a false statement of fact.

 

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