FREQUENTLY Asked Questions

How do you submit a 510(k) using the safety and performance based pathway?

View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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.

Related Terms:
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST