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Compliance In Focus
Posted by Brandy Chittester on Thu, Aug 15, 2013

PMA & 510(k): Disagreements Regarding Device Reviews

The Department of Health and Human Services (HHS) is the United States government’sDisagreements Regarding Device Reviews principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves, according to the government website.

The HHS conducted a study, “Scientific Disagreements Regarding Medical Device Regulatory Decisions” in response to the discrepancies reported at the Center for Devices and Radiological Health (CDRH) regarding reviewing standards of medical devices.

For background, the CDRH reviews data for safety and effectiveness pertaining to an investigational device. The approval path for devices is different depending o classification (Class I, II, or III) and level of risk to potential patients. For more information the approval path for a device, check out IMARC’s whitepaper for an in-depth look!

As the report notes, “Scientific disagreements among FDA reviewers may arise for many reasons. When reviewers are unable to resolve a disagreement through open communication, a fair and transparent resolution process is essential to ensure scientific integrity.” Most of the disputes concerned whether medical device under review met applicable standards. Examples were mentioned on how reviewers and managers could disagree on whether:

  • Clinical trial data submitted in a PMA application demonstrate safety and effectiveness
  • A 510(k) application demonstrates that a device is substantially equivalent to a predicate device

The HHS report includes three recommendations to the FDA to reduce review disputes which could prolong the path to approval and keep a device from getting to the market and patients.

  1. Define more clearly its requirements for documenting and resolving scientific disagreements
  2. Train all reviewers and managers on the new policies and procedures for resolving scientific disagreements
  3. Clearly assign accountability for the contents of the administrative files of all submissions

It’s essential that the FDA’s reviewing process is efficient, reliable, and based on scientific integrity. The public needs to have confidence that when a device reaches the market it is safe, effective, and deserves to be there.  

How do you think these types of discrepancies should be handled? How do you think these processes effect approval time? Share your thoughts with us!

Photo Credit: Gerry Dincher

510(k) Current Status and Considerations

Topics: The Department of Health and Human Services, 510(k), PMA

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