Devices

Guidance Published on Device Postmarket Surveillance

FDA has finalized a guidance on “Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act” that provides recommendations on the format, content, and review of postmarket surveillance plan submissions. Section 522 gives FDA the authority to order postmarket surveillance for any Class 2 or 3 device if the device’s failure would be reasonably likely to have serious adverse health consequences.

Once a surveillance order is issued, a manufacturer must submit a postmarket surveillance plan within 30 days and begin surveillance within 15 months, according to the guidance. It recommends the elements that each plan should contain, including:

· sample size calculation (statistically justified and based on study hypothesis, where applicable)·

· 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

· description of data collection procedures (including recruitment plans, enrollment targets, plans to minimize losses to follow-up, follow-up rate targets, quality assurance, and control), where applicable

· statistical analysis

· data collection forms, informed consent forms, and IRB approval or IRB exemption forms, where applicable

The document says FDA may identify device issues that are appropriate for postmarket surveillance at any point during its life cycle. “Such issues may be identified through a variety of sources including analysis of 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,” it says.

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