Please note that it is no longer necessary to submit the form in triplicate.
Section 2: to be completed by the FDA Compliance Officer.
Section 3: the Importer's Certificate is to be completed by the Importer of Record when the authorized reconditioning operations have been completed.
Sections 4 and 5: to be completed by FDA Investigator/Inspector or individual verifying the reconditioning was completed.
| Question | Answer |
|---|---|
| Form Name | Form FDA 766 |
| Form Length | 4 pages |
| Fillable? | Yes |
| Fillable fields | 44 |
| Avg. time to fill out | 8 min |
| Other names | FDA 766, FDA-766, Form FDA 766, FDA 766 form, Application for Authorization to Relabel or Recondition Non-Compliant Articles |
| Edition | Rev 05/24 |
| Matches the agency's file | Yes, checked October 3, 2026 |
| Official source | Form FDA 766 (Rev 05/24), Food and Drug Administration |
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