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          Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 
					Guidance for Industry
		
		July 2023


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    PrintDocket Number:
		    FDA-2023-D-2827
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition
          Center for Veterinary Medicine
          Office of Regulatory Affairs


**Issued April 2020
Updated July 2023**

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

The Accredited Third-Party Certification Program regulation (21 CFR part 1, subpart M) establishes a voluntary program for the recognition of accreditation bodies (ABs) that accredit third-party certification bodies (CBs) to conduct food safety audits and issue food or facility certifications to eligible foreign entities for the purposes specified in sections 801(q) and 806 of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 381 and 384b).[1] The regulation requires that recognized ABs and accredited CBs perform certain onsite observations and examinations.

Due to the ongoing, international impact of COVID-19, FDA is issuing this guidance to temporarily provide the Accredited Third-Party Certification Program’s currently-recognized ABs and accredited CBs flexibility, in certain circumstances, regarding the following requirements:

The requirement for recognized ABs to monitor the performance of CBs they have accredited under the program by conducting onsite observations of a representative sample of regulatory audits performed by the CBs they accredited and to visit the CBs’ headquarters (or other location, as needed) no later than 1 year after the initial date of accreditation of the CB and every 2 years thereafter.
	The requirement that certificates be issued for a term only up to 12 months for already- issued certifications issued under the Accredited Third-Party Certification Program.This guidance (originally titled “Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency”) was initially implemented without prior public comment on April 22, 2020, because FDA had determined that prior public participation was not feasible or appropriate (21 CFR 10.115(g)(2)) given the exigent circumstances related to the COVID-19 public health emergency. For the reasons discussed in Section II.A., and to clarify that the policies continue to reflect our current thinking, FDA is now reissuing this guidance in accordance with 21 CFR 10.115(c) and 10.115(g)(4). The policies are unchanged from the April 2020 guidance.

In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word *should* in Agency guidance means that something is suggested or recommended, but not required.

Download the Guidance

[1] For information on Part 1, Subpart M, see Accredited Third-Party Certification Program and FSMA Final Rule on Accredited Third-Party Certification.

Related Information

FDA Updates Duration of Enforcement Discretion Policies in Two COVID-19 Era FSMA Guidances July 13, 2023
	FDA Issues Federal Register Notice to Announce Status of COVID-19 Guidance Documents When Public Health Emergency Expires March 10, 2023
	FDA COVID-19 Information
	Imports & Exports Guidance Documents & Regulatory Information
	Food Safety and the Coronavirus Disease 2019 (ARCHVIED)


 
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						All written comments should be identified with this document's docket number: FDA-2023-D-2827.

                                                                                  Content current as of:
      07/13/2023
         
                  
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