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.