U.S. Code of Federal Regulations

Regulations most recently checked for updates: Mar 18, 2025

All TitlesTitle 21Chapter IPart 1Subpart M - Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

RECOGNITION OF ACCREDITATION BODIES UNDER THIS SUBPART
§ 1.610 - Who is eligible to seek recognition?
§ 1.611 - What legal authority must an accreditation body have to qualify for recognition?
§ 1.612 - What competency and capacity must an accreditation body have to qualify for recognition?
§ 1.613 - What protections against conflicts of interest must an accreditation body have to qualify for recognition?
§ 1.614 - What quality assurance procedures must an accreditation body have to qualify for recognition?
§ 1.615 - What records procedures must an accreditation body have to qualify for recognition?
§ 1.600 - What definitions apply to this subpart?
§ 1.601 - Who is subject to this subpart?

REQUIREMENTS FOR ACCREDITATION BODIES THAT HAVE BEEN RECOGNIZED UNDER THIS SUBPART
§ 1.620 - How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
§ 1.621 - How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
§ 1.622 - How must a recognized accreditation body monitor its own performance?
§ 1.623 - What reports and notifications must a recognized accreditation body submit to FDA?
§ 1.624 - How must a recognized accreditation body protect against conflicts of interest?
§ 1.625 - What records requirements must an accreditation body that has been recognized meet?

PROCEDURES FOR RECOGNITION OF ACCREDITATION BODIES UNDER THIS SUBPART
§ 1.630 - How do I apply to FDA for recognition or renewal of recognition?
§ 1.631 - How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
§ 1.632 - What is the duration of recognition?
§ 1.633 - How will FDA monitor recognized accreditation bodies?
§ 1.634 - When will FDA revoke recognition?
§ 1.635 - What if I want to voluntarily relinquish recognition or do not want to renew recognition?
§ 1.636 - How do I request reinstatement of recognition?

ACCREDITATION OF THIRD-PARTY CERTIFICATION BODIES UNDER THIS SUBPART
§ 1.640 - Who is eligible to seek accreditation?
§ 1.641 - What legal authority must a third-party certification body have to qualify for accreditation?
§ 1.642 - What competency and capacity must a third-party certification body have to qualify for accreditation?
§ 1.643 - What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
§ 1.644 - What quality assurance procedures must a third-party certification body have to qualify for accreditation?
§ 1.645 - What records procedures must a third-party certification body have to qualify for accreditation?

REQUIREMENTS FOR THIRD-PARTY CERTIFICATION BODIES THAT HAVE BEEN ACCREDITED UNDER THIS SUBPART
§ 1.650 - How must an accredited third-party certification body ensure its audit agents are competent and objective?
§ 1.651 - How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
§ 1.652 - What must an accredited third-party certification body include in food safety audit reports?
§ 1.653 - What must an accredited third-party certification body do when issuing food or facility certifications?
§ 1.654 - When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
§ 1.655 - How must an accredited third-party certification body monitor its own performance?
§ 1.656 - What reports and notifications must an accredited third-party certification body submit?
§ 1.657 - How must an accredited third-party certification body protect against conflicts of interest?
§ 1.658 - What records requirements must a third-party certification body that has been accredited meet?

PROCEDURES FOR ACCREDITATION OF THIRD-PARTY CERTIFICATION BODIES UNDER THIS SUBPART
§ 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?
§ 1.661 - What is the duration of accreditation by a recognized accreditation body?
§ 1.662 - How will FDA monitor accredited third-party certification bodies?
§ 1.663 - How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
§ 1.664 - When would FDA withdraw accreditation?
§ 1.665 - What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
§ 1.666 - How do I request reaccreditation?

ADDITIONAL PROCEDURES FOR DIRECT ACCREDITATION OF THIRD-PARTY CERTIFICATION BODIES UNDER THIS SUBPART
§ 1.670 - How do I apply to FDA for direct accreditation or renewal of direct accreditation?
§ 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?
§ 1.672 - What is the duration of direct accreditation?

REQUIREMENTS FOR ELIGIBLE ENTITIES UNDER THIS SUBPART
§ 1.680 - How and when will FDA monitor eligible entities?
§ 1.681 - How frequently must eligible entities be recertified?

GENERAL REQUIREMENTS OF THIS SUBPART
§ 1.690 - How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
§ 1.691 - How do I request reconsideration of a denial by FDA of an application or a waiver request?
§ 1.692 - How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
§ 1.693 - How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
§ 1.694 - Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
§ 1.695 - Are the records obtained by FDA under this subpart subject to public disclosure?

REQUIREMENTS FOR USER FEES UNDER THIS SUBPART
§ 1.700 - Who is subject to a user fee under this subpart?
§ 1.705 - What user fees are established under this subpart?
§ 1.710 - How will FDA notify the public about the fee schedule?
§ 1.715 - When must a user fee required by this subpart be submitted?
§ 1.720 - Are user fees under this subpart refundable?
§ 1.725 - What are the consequences of not paying a user fee under this subpart on time?
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