The U.S. Food and Drug Administration (FDA) is issuing a guidance to communicate its temporary policy regarding certain requirements under the FDA Food Safety Modernization Act (FSMA) Accredited Third-Party Certification Program for foreign food entities and their products. The guidance addresses the current challenges with conducting onsite monitoring activities during the COVID-19 public health emergency by providing temporary flexibility so that recognized accreditation bodies (ABs) can maintain the accreditations of certification bodies (CBs), and so that already-issued certifications need not lapse, where certain safeguards are in place.

Recognized ABs are required to monitor the CBs they accredit through a comprehensive assessment of their performance, which includes: a review of the CB’s self-assessment; its regulatory audit reports; notifications submitted to the FDA; onsite observations of regulatory audits performed by the CB; and a visit to the CB’s headquarters no later than one year after the initial date of accreditation and every two years thereafter for the duration of the CB’s accreditation. While certain monitoring requirements can be done remotely, we recognize that it may be temporarily impractical to conduct onsite monitoring activities; therefore, in certain circumstances, the FDA does not intend to enforce the requirements for the onsite monitoring activities.