- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Global Regulatory Operations and Policy, Office of Regulatory AffairsOffice of Medical Products and Tobacco, Center for Devices and Radiological Health
If a product defect or noncompliance with the Federal standard is discovered by a manufacturer (or x-ray equipment assembler), he may wish to initiate repair simultaneously with notification to FDA so that down time is minimized. Part 1003 requires that FDA (and others) be notified of radiation safety defects or failure to comply with a performance standard, and Part 1004 requires that the manufacturer must repair, replace, or refund the purchase price of a defective or noncompliant product. The correction of the product must be performed pursuant to a plan approved by FDA (21 CFR 1004.6
The *Federal Food, Drug, and Cosmetic Act, Subchapter C-Electronic Product Radiation Control,* and the regulations, do not preclude purchaser notification and correction of a defect or noncompliance prior to the approval of a plan; however, such corrective action would still be subject to a plan approved by FDA. To avoid the possibility of having to prepare and implement a second corrective action plan, a manufacturer or assembler should communicate with the Food and Drug Administration as early as possible after discovery of a defect or failure to comply.
*Material between asterisks is new or revised*
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-S-0610.