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device studies? The information in this guidance applies to all clinical trials, including those postmarketing clinical trials that FDA requires an applicant52 to conduct53 for drugs and biological products. Many of the considerations outlined in this guidance may also be relevant to postmarket device studies.54 51 FDA does not endorse any specific identification method. Sponsors may consider the National Institute of Standards and Technology (NIST) Digital Identity Guidelines, Special Publication 800-63A—Enrollment and Identity Proofing Requirements When Developing an Identity Verification Plan, available at https://pages.nist.gov/800-63-3/sp800-63a.html. 52 After a company submits a marketing application (e.g., new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), De Novo Classification Request, or premarket notification (510(k)) for review, the company is referred to as the applicant. The person who initiates a clinical investigation is referred to as the sponsor (see 21 CFR 312.3 and 812.3(n)). 53 Specifically, this response is intended to apply to studies or clinical trials required under 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)), confirmatory trials for drugs approved under the accelerated approval pathway (21 U.S.C. 356(c)(2)(A)) and deferred pediatric studies (21 U.S.C. 355B). 54 For devices subject to PMA, FDA may require post-approval studies as a condition of approval (21 CFR 814.82(a)(2)). FDA may also require manufacturers to conduct postmarket surveillance studies of certain class II and class III devices under section 522 of the FD&C Act (21 U.S.C. 360l). Contains Nonbinding Recommendations 30 Applicants who are required to complete postmarketing clinical trials for drugs or biological products follow a timetable that includes due dates for completing certain milestones in the trial. FDA encourages applicants to inform FDA as soon as possible if they experience COVID-19- related delays that may affect the applicant’s ability to meet the applicable interim,55 trial completion, and/or final report submission milestone(s). These applicants should propose feasible revised milestones for interim, trial completion, and/or final report submission milestone(s).56 For post-market device studies, the approved post-approval study protocol or post-market surveillance plan generally includes due dates for completing certain study milestones. Due dates for certain milestones may also be listed expressly in the order requiring the postmarket study. Applicants required to complete such studies should similarly inform FDA as soon as possible of COVID-19-related delays that may affect the applicant’s ability to meet those milestones and propose feasible revised milestones. Applicants with PMRs or required postmarket device studies should also provide an explanation to FDA of how COVID-19 impacts the ability to meet the original milestones. FDA will evaluate the facts and circumstances of the explanation provided, as well as the conduct of the applicant, in determining whether the applicant is in compliance with the applicable authority requiring the postmarketing trial or postmarket device study after the milestone has been missed. Additional considerations for drug and biological product PMRs include: • PMRs Under Section 505(o)(3) of the FD&C Act. FDA will continue to make “good cause” determinations on a case-by-case basis for all missed milestones, including those where the applicant asserts that its failure to meet a PMR interim, trial completion, and/or final report submission milestone(s) is related to the current public health emergency. • Deferred Pediatric Study PMRs Under the Pediatric Research Equity Act (PREA). 57 If circumstances involving COVID-19 have affected an applicant’s ability to complete a PREA PMR, applicants may request a deferral extension for the final report submission milestone. If an applicant has not obtained a deferral extension and fails to submit required PREA studies by the final report submission date listed in the PREA PMR, FDA is required to issue a noncompliance letter to the applicant.58 55 Interim milestones refer to those due dates scheduled to occur between the final protocol submission and trial completion milestones. 56 Although a revised trial completion date may be acknowledged by FDA, for drugs and biological product PMRs, the original projected completion date will continue to be displayed on the FDA’s Postmarket Requirements and Commitments web page. 57 Section 505B(a)(3)(B) of the FD&C Act governs the process and timelines required for requests for a deferral extension for deferred pediatric studies required under section 505B of the FD&C Act (21 U.S.C. 355c) (often referred to as PREA PMRs). 58 See section 505B(d)(1) of the FD&C Act (21 U.S.C. 355c(d)(1)). Contains Nonbinding Recommendations 31 • PMRs Under Accelerated Approval. For confirmatory trials, if an applicant misses an interim, trial completion, and/or final report submission milestone, FDA will review the applicant’s explanation for the delay, as well as assess the trial’s progress prior to the current public health emergency, before determining whether or not the applicant has been compliant with its milestone obligations. • Annual Status Reports of PMRs. Applicants must continue to follow the annual reporting requirements for PMRs59 and should 

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