---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchA/part1/subpartM"
level: "subpart"
label: "Subpart M"
heading: "Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchA-part1-subpartM"
sections_count: 60
---

# Subpart M — Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter A — General › Part 1 — General Enforcement Regulations

## Sections

- [§1.600. What definitions apply to this subpart?](/cfr/21/1.600.md)
- [§1.601. Who is subject to this subpart?](/cfr/21/1.601.md)
- [§1.610. Who is eligible to seek recognition?](/cfr/21/1.610.md)
- [§1.611. What legal authority must an accreditation body have to qualify for recognition?](/cfr/21/1.611.md)
- [§1.612. What competency and capacity must an accreditation body have to qualify for recognition?](/cfr/21/1.612.md)
- [§1.613. What protections against conflicts of interest must an accreditation body have to qualify for recognition?](/cfr/21/1.613.md)
- [§1.614. What quality assurance procedures must an accreditation body have to qualify for recognition?](/cfr/21/1.614.md)
- [§1.615. What records procedures must an accreditation body have to qualify for recognition?](/cfr/21/1.615.md)
- [§1.620. How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?](/cfr/21/1.620.md)
- [§1.621. How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?](/cfr/21/1.621.md)
- [§1.622. How must a recognized accreditation body monitor its own performance?](/cfr/21/1.622.md)
- [§1.623. What reports and notifications must a recognized accreditation body submit to FDA?](/cfr/21/1.623.md)
- [§1.624. How must a recognized accreditation body protect against conflicts of interest?](/cfr/21/1.624.md)
- [§1.625. What records requirements must an accreditation body that has been recognized meet?](/cfr/21/1.625.md)
- [§1.630. How do I apply to FDA for recognition or renewal of recognition?](/cfr/21/1.630.md)
- [§1.631. How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?](/cfr/21/1.631.md)
- [§1.632. What is the duration of recognition?](/cfr/21/1.632.md)
- [§1.633. How will FDA monitor recognized accreditation bodies?](/cfr/21/1.633.md)
- [§1.634. When will FDA revoke recognition?](/cfr/21/1.634.md)
- [§1.635. What if I want to voluntarily relinquish recognition or do not want to renew recognition?](/cfr/21/1.635.md)
- [§1.636. How do I request reinstatement of recognition?](/cfr/21/1.636.md)
- [§1.640. Who is eligible to seek accreditation?](/cfr/21/1.640.md)
- [§1.641. What legal authority must a third-party certification body have to qualify for accreditation?](/cfr/21/1.641.md)
- [§1.642. What competency and capacity must a third-party certification body have to qualify for accreditation?](/cfr/21/1.642.md)
- [§1.643. What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?](/cfr/21/1.643.md)
- [§1.644. What quality assurance procedures must a third-party certification body have to qualify for accreditation?](/cfr/21/1.644.md)
- [§1.645. What records procedures must a third-party certification body have to qualify for accreditation?](/cfr/21/1.645.md)
- [§1.650. How must an accredited third-party certification body ensure its audit agents are competent and objective?](/cfr/21/1.650.md)
- [§1.651. How must an accredited third-party certification body conduct a food safety audit of an eligible entity?](/cfr/21/1.651.md)
- [§1.652. What must an accredited third-party certification body include in food safety audit reports?](/cfr/21/1.652.md)
- [§1.653. What must an accredited third-party certification body do when issuing food or facility certifications?](/cfr/21/1.653.md)
- [§1.654. When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?](/cfr/21/1.654.md)
- [§1.655. How must an accredited third-party certification body monitor its own performance?](/cfr/21/1.655.md)
- [§1.656. What reports and notifications must an accredited third-party certification body submit?](/cfr/21/1.656.md)
- [§1.657. How must an accredited third-party certification body protect against conflicts of interest?](/cfr/21/1.657.md)
- [§1.658. What records requirements must a third-party certification body that has been accredited meet?](/cfr/21/1.658.md)
- [§1.660. Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application?](/cfr/21/1.660.md)
- [§1.661. What is the duration of accreditation by a recognized accreditation body?](/cfr/21/1.661.md)
- [§1.662. How will FDA monitor accredited third-party certification bodies?](/cfr/21/1.662.md)
- [§1.663. How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?](/cfr/21/1.663.md)
- [§1.664. When would FDA withdraw accreditation?](/cfr/21/1.664.md)
- [§1.665. What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?](/cfr/21/1.665.md)
- [§1.666. How do I request reaccreditation?](/cfr/21/1.666.md)
- [§1.670. How do I apply to FDA for direct accreditation or renewal of direct accreditation?](/cfr/21/1.670.md)
- [§1.671. How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application?](/cfr/21/1.671.md)
- [§1.672. What is the duration of direct accreditation?](/cfr/21/1.672.md)
- [§1.680. How and when will FDA monitor eligible entities?](/cfr/21/1.680.md)
- [§1.681. How frequently must eligible entities be recertified?](/cfr/21/1.681.md)
- [§1.690. How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?](/cfr/21/1.690.md)
- [§1.691. How do I request reconsideration of a denial by FDA of an application or a waiver request?](/cfr/21/1.691.md)
- [§1.692. How do I request internal agency review of a denial of an application or waiver request upon reconsideration?](/cfr/21/1.692.md)
- [§1.693. How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?](/cfr/21/1.693.md)
- [§1.694. Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?](/cfr/21/1.694.md)
- [§1.695. Are the records obtained by FDA under this subpart subject to public disclosure?](/cfr/21/1.695.md)
- [§1.700. Who is subject to a user fee under this subpart?](/cfr/21/1.700.md)
- [§1.705. What user fees are established under this subpart?](/cfr/21/1.705.md)
- [§1.710. How will FDA notify the public about the fee schedule?](/cfr/21/1.710.md)
- [§1.715. When must a user fee required by this subpart be submitted?](/cfr/21/1.715.md)
- [§1.720. Are user fees under this subpart refundable?](/cfr/21/1.720.md)
- [§1.725. What are the consequences of not paying a user fee under this subpart on time?](/cfr/21/1.725.md)