Tuesday 20 February 2018

Shutdown Delays Medical Device Approvals (510(k)s)

As the shutdown continues the impact continues to be felt.  Some disruptions are expected, but given the broad and general directive from the Department of Health and Human Services (DHSS) which oversees the FDA, some are difficult to predict.

A new disruption discovered this week is a delay in FY 2014 medical device approvals. According to the Agency the CDRH is only working on submissions received during FY 2013, which concluded on Sept. 30. Even though user fee programs were expected to function normally, the FDA will log in submission received on Oct. 1 and forward, but conduct no administrative or substantive review. This doesn’t appear to impact request for additional information (AI Letters) for FY 2013 submissions. Typically a 510(k) will take 90-days for approval, but now with the shutdown lingering on and the potential for a back-log, it’s a guessing game on how long device approvals will take.

The impact is confirmed on medical device submissions, but is also likely for New Drug Applications (NDA) and other user-supported pre-market clearances.

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