CDRH now taking radiation safety reports by email

By staff writers

June 11, 2020 -- The U.S. Food and Drug Administration (FDA)'s Center for Devices and Radiological Health (CDRH) is now accepting radiation safety reports by email.

In a June 10 announcement, the CDRH said that all radiation safety reports can now be submitted to the center using the email address, including product reports, annual reports, notifications of product defects, corrective action plan (CAP) proposals, and accidental radiation occurrences (AROs).

Reports should be submitted in PDF format or packaged by the FDA's eSubmitter packaging procedures and attached to email. Electronic submissions no longer need to be transferred to a physical medium and mailed to the CDRH.

The FDA noted that the email address should not be used to submit premarket approval (PMA) or 510(k) submissions for products.

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