By Jof Enriquez,
Follow me on Twitter @jofenriq
The US Food and Drug Administration (FDA) has issued final guidance for manufacturers subject to postmarket surveillance requirements of certain Class II and Class III medical devices under Section 522 of the US Federal Food, Drug and Cosmetic Act (the Act), as amended by Section 212 of the Food and Drug Modernization Act (FDAMA) of 1997, and Section 212 of the Food and Drug Modernization Act (FDAMA) of 1997.
According to the final guidance, FDA is authorized to require postmarket surveillance for a Class II and Class III device if:
- The device’s failure would be reasonably likely to have serious adverse health consequences,
- The device is intended to be implanted in the body for more than one year,
- The device is a life-sustaining or life-supporting device used outside a device user facility, or
- The device is expected to have significant use in pediatric populations.
Under Section 616 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA can order a postmarket surveillance at the time of device approval or clearance or any time thereafter. Section 616 also requires that manufacturers start postmarket surveillance not later than 15 months after the day the FDA order is issued.
By exercising authority to require postmarket surveillance activities under Section 522 (as amended), FDA is addressing some of its perceived shortcomings in conducting proper surveillance, as detailed in a 2015 report published by the Brookings Institution, Emergo notes in a blog post.
The final guidance clarifies the timing when FDA can issue a postmarket surveillance order, and recommends the content of the surveillance plan and the subsequent interim and final postmarket surveillance reports to be submitted to the agency, according to Lexology. The document also describes the process for FDA’s review of the surveillance plan.
In determining whether a postmarket surveillance is warranted to study a device issue or obtain more information, FDA says it will consider various sources, including adverse event reports, a recall or corrective action, post-approval data, review of premarket data, reports from other governmental authorities, or review of scientific literature.
To review an issue in greater depth, FDA will then form a cross-Center team (i.e., pre-522 team), consisting of FDA epidemiologists, clinicians, or other experts, to decide whether or not a 522 order should be issued to address a public health question. The guidance provides a list of questions for the pre-522 team to make a determination.
The 522 order should identify the premarket submission involved (i.e., 510(k), PMA, PDP, or HDE, or de novo petition), the public health questions, the rationale for the 522 order, and postmarket surveillance design recommendations to assist the manufacturer in preparing the plan. The manufacturer should cite the postmarket surveillance (PS) number (assigned by FDA for the corresponding 522 order) when submitting the postmarket surveillance plan, which must occur within 30 days of receipt of the 522 order.
In general, Section 522 authorizes FDA to order prospective postmarket surveillance for a duration of up to 36 months, unless the manufacturer and FDA agree to extend that time frame. FDA reserves the right to extend a prospective surveillance period beyond 36 months for devices being used in pediatric patients. FDA and the manufacturer should agree on a time frame in such cases.
FDA requires the manufacturer to include several types of information in postmarket surveillance submissions, including (but not limited to):
- Background (e.g., regulatory history, brief description of the device, indications for use)
- Postmarket surveillance design
- Primary and secondary endpoints (including definitions for endpoints, success criteria, a list of expected adverse events/complications, an agreement to collect unexpected adverse events, and a plan to assess relatedness of endpoints with the device and/or the procedure)
- Length of follow-up, follow-up schedule, description of baseline, and follow-up assessments, where applicable for statistical analysis
- Reporting schedule for interim and final reports
Manufacturers should submit an interim postmarket surveillance report every six months for the first two years of the postmarket surveillance and annually thereafter. They also are recommended to submit a final postmarket surveillance report no later than three months after study/surveillance completion.
FDA notes that, where appropriate, it may be possible to meet a 522 order requirement through prospective or retrospective analysis of data from real-world data sources, such as device registries and electronic health records (EHRs).
After reviewing the submitted surveillance plan, FDA issues one of five types of decision letters. In case of disputed decisions, the manufacturer has a few recourse options described in the guidance.