In a June 10 announcement, the CDRH said that all radiation safety reports can now be submitted to the center using the RadHealthCustomerService@fda.hhs.gov 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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