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How do you submit a 510(k) using the safety and performance based pathway?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

510(k)s using the Safety and Performance Based Pathway must be submitted in an electronic format (eCopy). After a 510(k) is received by the FDA, FDA does NOT return the submission or any copies to the submitter.

Requests should be sent to the appropriate Document Control Center. The current mailing address for CDRH’s Document Control Center is provided on the eCopy Program for Medical Device Submissions webpage.

FDA recommends submitters send 510(k)s to the FDA by a method which will provide a signed receipt of delivery, for example, registered mail with a return receipt or a commercial delivery service. Submitters should receive an acknowledgment letter from the FDA, including the assigned 510(k) number, within one week of delivery.

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