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Title 21

Displaying title 21, up to date as of 7/16/2026. Title 21 was last amended 7/09/2026.
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  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter A —General
  4. Part 1 —General Enforcement Regulations
  5. Subpart M   View Full Text
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter AGeneral1 – 99
Part 1General Enforcement Regulations1.1 – 1.1465
Subpart MAccreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications1.600 – 1.725
§ 1.600What definitions apply to this subpart?
§ 1.601Who is subject to this subpart?
Recognition of Accreditation Bodies Under This Subpart1.610 – 1.615
§ 1.610Who is eligible to seek recognition?
§ 1.611What legal authority must an accreditation body have to qualify for recognition?
§ 1.612What competency and capacity must an accreditation body have to qualify for recognition?
§ 1.613What protections against conflicts of interest must an accreditation body have to qualify for recognition?
§ 1.614What quality assurance procedures must an accreditation body have to qualify for recognition?
§ 1.615What records procedures must an accreditation body have to qualify for recognition?
Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart1.620 – 1.625
§ 1.620How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
§ 1.621How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
§ 1.622How must a recognized accreditation body monitor its own performance?
§ 1.623What reports and notifications must a recognized accreditation body submit to FDA?
§ 1.624How must a recognized accreditation body protect against conflicts of interest?
§ 1.625What records requirements must an accreditation body that has been recognized meet?
Procedures for Recognition of Accreditation Bodies Under This Subpart1.630 – 1.636
§ 1.630How do I apply to FDA for recognition or renewal of recognition?
§ 1.631How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
§ 1.632What is the duration of recognition?
§ 1.633How will FDA monitor recognized accreditation bodies?
§ 1.634When will FDA revoke recognition?
§ 1.635What if I want to voluntarily relinquish recognition or do not want to renew recognition?
§ 1.636How do I request reinstatement of recognition?
Accreditation of Third-Party Certification Bodies Under This Subpart1.640 – 1.645
§ 1.640Who is eligible to seek accreditation?
§ 1.641What legal authority must a third-party certification body have to qualify for accreditation?
§ 1.642What competency and capacity must a third-party certification body have to qualify for accreditation?
§ 1.643What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
§ 1.644What quality assurance procedures must a third-party certification body have to qualify for accreditation?
§ 1.645What 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 Subpart1.650 – 1.658
§ 1.650How must an accredited third-party certification body ensure its audit agents are competent and objective?
§ 1.651How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
§ 1.652What must an accredited third-party certification body include in food safety audit reports?
§ 1.653What must an accredited third-party certification body do when issuing food or facility certifications?
§ 1.654When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
§ 1.655How must an accredited third-party certification body monitor its own performance?
§ 1.656What reports and notifications must an accredited third-party certification body submit?
§ 1.657How must an accredited third-party certification body protect against conflicts of interest?
§ 1.658What records requirements must a third-party certification body that has been accredited meet?
Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart1.660 – 1.666
§ 1.660Where 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?
§ 1.661What is the duration of accreditation by a recognized accreditation body?
§ 1.662How will FDA monitor accredited third-party certification bodies?
§ 1.663How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
§ 1.664When would FDA withdraw accreditation?
§ 1.665What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
§ 1.666How do I request reaccreditation?
Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart1.670 – 1.672
§ 1.670How do I apply to FDA for direct accreditation or renewal of direct accreditation?
§ 1.671How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application?
§ 1.672What is the duration of direct accreditation?
Requirements for Eligible Entities Under This Subpart1.680 – 1.681
§ 1.680How and when will FDA monitor eligible entities?
§ 1.681How frequently must eligible entities be recertified?
General Requirements of This Subpart1.690 – 1.695
§ 1.690How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
§ 1.691How do I request reconsideration of a denial by FDA of an application or a waiver request?
§ 1.692How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
§ 1.693How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
§ 1.694Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
§ 1.695Are the records obtained by FDA under this subpart subject to public disclosure?
Requirements for User Fees Under This Subpart1.700 – 1.725
§ 1.700Who is subject to a user fee under this subpart?
§ 1.705What user fees are established under this subpart?
§ 1.710How will FDA notify the public about the fee schedule?
§ 1.715When must a user fee required by this subpart be submitted?
§ 1.720Are user fees under this subpart refundable?
§ 1.725What are the consequences of not paying a user fee under this subpart on time?
eCFR Content