FDA issues guidance on FSMA third-party certification amid COVID-19

The guidance addresses the 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. While certain monitoring requirements can be done remotely, FDA recognizes that it may be temporarily impractical to conduct on-site monitoring activities; therefore, in certain circumstances, the agency does not intend to enforce those requirements.

For certificates set to expire, the FDA understands that current travel restrictions and advisories related to COVID-19 may hinder the ability of accredited CBs to conduct the on-site regulatory audits needed to recertify the foreign entity. An accredited CB that has issued a certificate with an upcoming expiration date can contact FDA at FDAthirdpartyprogram@fda.hhs.gov to discuss the term.