FDA issues new draft guidances on device postmarket surveillance

Regulatory NewsRegulatory News | 28 May 2021 |  By 

The US Food and Drug Administration (FDA) has issued two draft guidances to help device manufacturers comply with postmarket surveillance requirements and to understand the agency’s expectations for post-approval studies (PASs). The guidances have been revised to require new reporting on patient enrollment.
The first guidance spells out procedures for handling PASs imposed as a condition of premarket approval (PMA), while the second addresses FDA’s interpretation of postmarket surveillance orders under section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to  certain class II or class III medical devices.
William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health (CDRH), announced in a 26 May statement that the two guidances “provide clarity that will help manufacturers better understand the FDA’s requirements and expectations for ongoing data collection for certain approved or cleared devices, which we believe will help increase reporting compliance.”
FDA is seeking feedback on the two draft guidances by 28 July 2021.
GAO report notes enrollment difficulties
The FDA’s issuance of these guidances follows a 2015 Government Accountability Office (GAO) report on the characteristics and status of postmarket studies ordered from January 2007 to February 2015. FDA ordered most of these studies in 2012, to track safety concerns related to reports of severe pain in patients with implanted surgical mesh.
The GAO report found that 88% of the postmarket surveillance studies were inactive as of February 2015; the remainder were either ongoing or completed. Of the 40 ongoing studies, more than half were progressing adequately while the rest were delayed because of difficulty enrolling patients in studies. The report said FDA was working with manufacturers to improve their ability to enroll patients and suggest strategies to improve enrollment. (RELATED: GAO finds majority of postmarket surveillance studies FDA ordered for devices are inactive, Regulatory Focus 30 October 2015).
PAS enrollment status and progress reports  
The new draft guidance on handling PASs imposed by a PMA approval order replaces an earlier final version issued in 2009. The major changes call for the reporting of PAS enrollment status, PAS progress reports, and final post-approval study status reports.
An enrollment status report should detail the progress made toward meeting the enrollment milestones per the PMA approval order, while a PAS progress report should describe the status of the PAS prior to its completion, and should address subject accountability and device performance.
A final PAS report is a written report of a completed or terminated PAS study.
FDA “intends to require in the approval order that PAS progress reports are to be submitted every six months until subject enrollment has been completed and annually thereafter.”
Also, FDA “intends to require” in the approval order that the final PAS report be submitted no later than three months after study completion.”
To help facilitate and triage review, FDA “recommends that the sponsor indicate the type of PAS report and time span on the report cover letter in bold letters,” either enrollment status reports, six-month PAS progress reports, 12-month PAS progress reports and final PAS reports.
The guidance specifies PAS enrollment status reports should be submitted when enrollment is complete. The reports should include the date the study protocol was approved, the start and completion date for clinical site recruitment, the number of institutional review board approvals and number of clinical sites at which the study was initiated, the subject enrollment start date and the expected completion date.
PAS progress reports should address the purpose of the study, including study goals, objectives and primary and secondary study endpoints, describe the study population and address specific illnesses or conditions. The reports should also cover the total number of subject to be studied, the schedule of subject follow-up, and an explanation for the number of subjects lost to follow-up, and any subject and physician-initiated discontinuations as well as patient deaths.
Final PAS status reports should also include the purpose of the study, a description of the study population, the begin and end dates, the date of database closure for the final PAS report, the final “accountability” of enrolled subjects, an explanation for any subjects lost to follow-up or subject and physician-initiated discontinuation, any deaths as well as a summary of the final safety and effectiveness findings.
Postmarket surveillance
The guidance on postmarket surveillance is meant to assist device manufacturers subject to section 522 comply with postmarket surveillance orders and contains a few minor revisions from the 2016 guidance, such as calling for the submission of enrollment reports. (RELATED: FDA finalizes guidance on postmarket device surveillance, Regulatory Focus 13 May 2016).
The guidance explains that FDA “intends to review enrollment reports to assess progress towards the surveillance plan milestones.”
The reports should include the date the surveillance plan was approved, the start and completion date for the clinical site recruitment, the number of institutional review board (IRB) approvals and number of clinical sites where the surveillance was initiated, the subject start ate and expected completion date, and the number of subjects enrolled.
The guidance also has a new section on considerations regarding pediatric population.
Section 522 of the FD&C Act provides the FDA with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices.
FDA says it considers multiple issues in deciding whether to issue a section 522 postmarket surveillance order for a class II or class III medical device.
Assuming statutory criteria are met, “the most important element” the agency’s pre-522 team will consider is identification of the public health question. The team will evaluate available data to characterize the public health question and determine whether the issue is addressed more appropriately during the premarket stage or as part of a 522 order. The guidance lays out details of the pre-522 team’s decision-making process.
The guidance states that FDA will assign a postmarket surveillance (PS) order number to each 522 order, which manufactures should cite when submitting a proposed postmarket surveillance plan.
Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act


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