StacksVerified U.S. regulatory reference

21 CFR §1003.20

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:
  1. (a)Identification of the product or products involved;
  2. (b)The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;
  3. (c)The expected usage for the product if known to the manufacturer;
  4. (d)A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard;
  5. (e)An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard;
  6. (f)A statement of the measures to be taken to repair such defect or to bring the product into compliance with the Federal standard;
  7. (g)The date and circumstances under which the defect was discovered; and
  8. (h)The identification of any trade secret information which the manufacturer desires kept confidential.