New Rad Health Email Reporting Available

FDA says that all radiation safety reports may now be submitted to CDRH by email to the RadHealthCustomerService@fda.hhs.gov mailbox. These include all report types, such as product reports, annual reports, and supplemental reports of all types, and all communications such as notifications of defect/failure to comply, corrective action plan proposals, and accidental radiation occurrences. Reports should be submitted in PDF format, or packaged by the eSubmitter packaging procedures and attached to the email. eSubmissions no longer need to be transferred to a physical medium and mailed to the CDRH Document Control Center. An eSubmitter user does not need to acquire an FDA Electronic Submissions Gateway account either, the agency says. The Rad Health mailbox should not be used to submit Premarket device PMA or 510(k) documents or eMDR submissions, it adds. Questions may be directed to DICE@fda.hhs.gov.

For more information on Radiological Health reports, a video is available here: How to Get your Electronic Product to the US Market and CDRH Learn: Electronic Product Certification and Quality Testing Programs.