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BACKGROUND:
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).
POLICY:
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*
Issued: 10/1/80
Revised: 3/95