21 CFR 820.180 - General requirements.
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.
(a)Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.
(b)Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
(c)Exceptions. This section does not apply to the reports required by § 820.20(c) Management review, § 820.22 Quality audits, and supplier audit reports used to meet the requirements of § 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.
Title 21 published on 2015-12-03
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 820 after this date.
- 21 CFR 864.3250 — Specimen Transport and Storage Container.
- 21 CFR 874.3540 — Prosthesis Modification Instrument for Ossicular Replacement Surgery.
- 21 CFR 886.4750 — Ophthalmic Eye Shield.
- 21 CFR 886.1780 — Retinoscope.
- 21 CFR 880.5270 — Neonatal Eye Pad.
- 21 CFR 882.1500 — Esthesiometer.
- 21 CFR 878.3910 — Noninflatable Extremity Splint.
- 21 CFR 874.1500 — Gustometer.
- 21 CFR 872.6300 — Rubber Dam and Accessories.
- 21 CFR 886.1350 — Keratoscope.
- 21 CFR 882.1200 — Two-Point Discriminator.
- 21 CFR 890.5700 — Cold Pack.
- 21 CFR 880.2930 — Apgar Timer.
- 21 CFR 876.5210 — Enema Kit.
- 21 CFR 862.2270 — Thin-Layer Chromatography System for Clinical Use.