Learn about Submitting Radiation Safety Reports by Email The U.S. Food and Drug Administration (FDA) added information on FDA.gov about filing by email Radiation Safety Reports for radiation emitting products. All Radiation Safety reports in PDF format or packaged using eSubmitter procedures may now be submitted as attachments and sent by email to the FDA's Center for Devices and Radiological Health at RadHealthCustomerService@fda.hhs.gov mailbox. 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 submissions (such as PMAs and 510(k)s) or electronic medical device reporting (eMDR) submissions are NOT accepted by this email address. Questions? If you have questions about these updates, contact the Division of Industry and Consumer Education. |
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