Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic (FD&C) Act

The FDA issued the guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” on May 16^th, 2016.  Section 522 of the FD&C Act provides the FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or class III devices.

Postmarket surveillance means the active, systematic, scientifically valid collection, analysis and interpretation of data or other information about a marketed device (21 CFR 822.3(i)).  The FDA has the authority to order postmarket surveillance for Class II or Class III medical devices that meet any of the following criteria:

• Failure of the device would be reasonably likely to have a serious adverse health consequence
• Expected to have significant use in pediatric populations
• Intended to be implanted in the body for more than one year
• Intended to be a life-supporting device used outside of a user facility

The FDA is authorized to order prospective postmarket surveillance for up to 36 months.  However, the FDA can require a prospective surveillance period of more than 36 months for devices that are expected to have significant use in pediatric populations.  The FDA may issue the postmarket surveillance order at the time of approval or anytime afterwards.

Examples of situations that may raise postmarket questions and lead to postmarket surveillance include:

• To better understand the nature of suspected problems reported in adverse event reports or in published literature
• To obtain more information on device performance associated with real-world clinical practice
• To address long term or infrequent safety and effectiveness issues for implantable and other devices for which the premarket testing provided limited information
• To better define the association between problems and devices when unexpected or unexplained serious adverse events occur after the device is marketed

The general requirements for a postmarket surveillance submission are outlined in CFR 822.9 and 822.10 and include but are not limited to:

• Postmarket plan objectives and hypotheses
• Postmarket surveillance design
• Sample size
• Description of follow-up
• Description of data collection procedures
• Reporting schedule for interim and final reports
• Statistical analysis

The FDA states in the guidance that the ability to adequately track and evaluate postmarket surveillance depends on the quality and timeliness of information provided. The Final Postmarket Surveillance Report should contain adequate information for the agency to identify the device being studied, the specific postmarket surveillance being conducted, the status of that postmarket surveillance, and the reasons for any delays or failures to complete the postmarket surveillance.  The FDA will then determine the postmarket surveillance status.  Failure to comply with the postmarket surveillance requirements under Section 522 renders the device misbranded under section 502(t)(3) of the Act, as stated in 21 CFR 822.20.

In order to increase transparency, the FDA posts information about postmarket surveillance on FDA’s 522 website.

Are the potential benefits of postmarket surveillance worth the extra time and resources when a device has already been approved by the FDA?

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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