Radiation Safety Reports Now Accepted by Email Radiation Safety reports in PDF format or packaged using eSubmitter procedures may now be submitted as attachments and sent to the FDA's Center for Devices and Radiological Health by email at RadHealthCustomerService@fda.hhs.gov. Information accepted by this email address includes: - Product reports, annual reports, and supplemental reports
- Communications such as notifications of defect or failure to comply, corrective action plan (CAP) proposals, and accidental radiation occurrences (AROs).
Note: Device Premarket Applications, 510(k) documents and Electronic Medical Device Reporting (eMDR) submissions are NOT accepted by this email address. If you have questions about this policy, contact the Division of Industry and Consumer Education. |
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