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Compliance In Focus
Posted by John Lehmann on Thu, Jan 5, 2012

Continuity in Medical Device Reviews

An article in Healing Innovations caught our eye. It reports that the FDA recently released a standard operating procedure (SOP) called “SOP: Management of Review Staff Changes During the Review of a Premarket Submission.”

In the past, personnel changes on a FDA team would impact a company undergoing the medical device review process. The Healing Innovation article outlines an experience a company had with a personnel change at the FDA, which was not a positive experience.

In a nutshell, here is what the new SOP promises. First, a newly assigned review team member is expected to follow the decisions and advice given by the individual they are replacing. Next, when staff becomes aware of information that may alter the information and data required for premarket review, they should receive concurrence from the appropriate management level before taking any action.

For proposed changes in the data requirements, staff should ask for data that imposes the least justified burden on the applicant. If the newly assigned review team member has a different supervisor than the lead reviewer, then concurrence of the lead reviewer’s supervisor is required.

Do you think the new SOP will have a positive impact? The intent seems good, but only time will tell.

Let us know what you think.

Topics: Medical Devices, john lehmann, FDA


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