Temporary policy regarding accredited third-party certification program onsite observation and certificate duration requirements during the COVID-19 public health emergency
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. United States. Food and Drug Administration. Office of Regulatory Affairs. issuing body. Center for Food Safety and Applied Nutrition (U.S.), issuing body. Center for Veterinary Medicine (U.S.), issuing body.
- Publication:
- [College Park, MD] : Center for Food Safety and Applied Nutrition, April 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Accreditation -- methods Certification -- methods Food Safety COVID-19 United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- 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 FD&C Act (21 U.S.C. 381 and 384b). The regulation requires that recognized ABs and accredited CBs perform certain onsite observations and examinations. Due to the impact of the public health emergency related to COVID-19, FDA is issuing this guidance to provide the Accredited Third-Party Certification Program's currently-recognized ABs and accredited CBs flexibility, in certain circumstances, regarding the following requirements: (1) 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. (2) 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 policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services Act (42 U.S.C. 247(d)(a)(2)).
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (5 pages)).
- NLM Unique ID:
- 9918227268506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227268506676