This guide was developed by the Office of Compliance, Center for Devices and Radiological Health (CDRH), to assist electronic product manufacturers in providing adequate reporting of radiation safety testing and compliance with performance standards. Reporting requirements are specified in Title 21 of the Code of Federal Regulations (CFR), Part 1002.
Reports submitted on radiation safety of electronic products must follow the appropriate guide (21 CFR 1002.7), or contain a justification why it was not followed. CDRH may reject an incomplete report and return it for completion. When the report is adequate for filing, it will be logged into the CDRH computer system and assigned an accession number. The submitter of the report will receive an acknowledgment letter with the accession number we assign to the report. Please reference this accession number in the future when providing additional information about this model family in either a supplement or the annual report.
WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is the manufacturer's responsibility to certify that their products comply with the applicable standard (21 CFR 1010 - 1050), based on a testing program in accordance with good manufacturing practices. The manufacturer is required to submit the report (21 CFR 1002) and to comply with all applicable importation requirements (21 CFR 1005) prior to the shipment of products in interstate commerce. If there are deficiencies, we may disapprove the firm's quality control and testing program or determine that the product contains a radiation defect or fails to comply with a standard. We will notify the manufacturer if we make such a determination. Then the manufacturer may be required to cease introduction into U.S. commerce until deficiencies are corrected, and to initiate a corrective action program (21 CFR 1003 - 1004) for products already introduced into commerce.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.