21 CFR Subpart M - Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
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- § 1.600 What definitions apply to this subpart?
- § 1.601 Who is subject to this subpart?
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Recognition of Accreditation Bodies Under This Subpart (§§ 1.610 - 1.615)
- § 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?
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Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart (§§ 1.620 - 1.625)
- § 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?
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Procedures for Recognition of Accreditation Bodies Under This Subpart (§§ 1.630 - 1.636)
- § 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?
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Accreditation of Third-Party Certification Bodies Under This Subpart (§§ 1.640 - 1.645)
- § 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?
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Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart (§§ 1.650 - 1.658)
- § 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?
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Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart (§§ 1.660 - 1.666)
- § 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?
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Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart (§§ 1.670 - 1.672)
- § 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?
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Requirements for Eligible Entities Under This Subpart (§§ 1.680 - 1.681)
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General Requirements of This Subpart (§§ 1.690 - 1.695)
- § 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?
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Requirements for User Fees Under This Subpart (§§ 1.700 - 1.725)
- § 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?
Source:
80 FR 74650, Nov. 27, 2015, unless otherwise noted.