Addresses for Electronic Product Radiation Control Reports and Recordkeeping

Center for Devices and Radiological Health, U.S. Food and Drug Administration

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
horizonal rule

Compliance Activities: Quality Starts From Within Through Continuous Improvement

Addresses for Electronic Product Radiation Control Reports and Recordkeeping

Address all reports of accidental radiation occurrences to:

Center for Devices and Radiological Health
Accidental Radiation Occurrence
Office of Compliance (HFZ-300)
2094 Gaither Road
Rockville, MD 20850

See Accidental Radiation Occurrences and Radiation Incidents for more information.

Address all reports of radiation defect or failure to comply with a federal performance standard to:

Center for Devices and Radiological Health
Notice of Defect/Noncompliance
Office of Compliance (HFZ-300)
2098 Gaither Road
Rockville, MD 20850

Information on radiation safety defects and failures to comply with a federal performance standard are found on the Reports and Records page.

Address all product, supplement, abbreviated, and annual reports to:

Center for Devices and Radiological Health
Electronic Product Reports
Office of Compliance (HFZ-307)
2098 Gaither Road
Rockville, MD 20850

See Title 21 CFR 1002.7 Submission of data and reports for complete information.

Information on the content of product, supplement, abbreviated, and annual reports is found on the Reports and Records page. Reporting guides for each product can be found under the Product/Program Areas page

Address all variance requests (Original with four copies) to:

Food and Drug Administration
Dockets Management Branch (HFA-305)
12420 Parklawn Drive, Room 1-23
Rockville, MD 20857

Information on requesting a variance from a federal performance standard is found on the Reports and Records page

horizonal rule

Center for Devices and Radiological Health / CDRH