- February 26, 2018
07:00 PM - 07:00 PM EST
The Custom Device Exemption allows medical device manufacturers to market certain devices designed to treat a unique pathology or physiological condition without premarket approval. A device that meets the criteria for a custom device is exempt from Premarket Approval (PMA) requirements and conformance to mandatory performance standards. Manufacturers of custom devices must report to the FDA annually, and annual reports are due to the FDA no later than March 31.
On Tuesday, February 27, 2018, the FDA hosted a webinar for manufacturers and other interested stakeholders to discuss and answer questions about the custom device annual report requirement. The webinar was an opportunity for impacted stakeholders to obtain clarity on the FDA’s expectations for the content of custom device annual reports to ensure completeness in meeting the reporting obligation. No registration is required.
Target Audience: Industry
If you have any questions, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.