The US FDA finalizes post-market surveillance guidance

Post-market surveillance – perhaps, the most important aspect for medical devices and drug manufacturers. Once the drug/product is released into the market, it is of utmost important to track the device’s performance in order to maintain the organization’s integrity towards patient safety. Usually, the FDA (Food and Drug Administration) calls for post-market surveillance reports during device approvals or any time thereafter. With 90% of the post-market surveillance reports which the health authority ordered in the past few years were categorized as inactive, the FDA finalized a new guidance.

The Federal Food, Drug, and Cosmetic Act (FD&C Act), constitutes FDA with the authority to require post-market surveillance of certain Class II and Class III devices. Newly finalized guidance reiterates the same and focuses on its lawful interpretation. As per the Food and Drug Administration Safety and Innovation Act (FDASIA) specification, the agency may issue “522 Order” calling companies to conduct surveillance studies. Once issued, the 522 order requires device/product manufacturers to commence surveillance studies no later than 15 months.

The order 522 – how it helps the device manufacturers? It provides,

  • An overview of the section of the law that allows FDA to require such studies
  • Information on how to fulfill 522 order obligations and
  • Recommendations on the format, content and review of the post-market surveillance plan submissions

What may call for post-market surveillance? As FDA exemplifies, a post-market surveillance is needed

  • When FDA wants to decode adverse event’s nature, severity or frequency of suspected problems
  • To get more insight on medical device performance in the real-world
  • To deal with long term/infrequent safety and effectiveness issues for implantable and other devices which have limited premarket testing information
  • To define the association between problems and devices post-marketing stint, to decode serious adverse events and the nature or frequency of them

As the FDA insists, in addition to 522 order, device manufacturers should also submit surveillance report every six months for the first two years and once in a year thereafter from the date of surveillance plan approval. However, the proposed surveillance plans will be evaluated by the FDA to determine the capability of collected data to answer the safety questions. Post evaluation, FDA issues letters such as “Not acceptable Letter, Approval Letter, Minor Deficiency Letter, Major Deficiency Letter, and Disapproval Letter.” For detailed information check out the FDA and Manufacturer Agreement on Surveillance Plan.

Apart from being aware of this post-market surveillance finalization, Class II device manufacturers should also be aligned with the upcoming UDI (Unique Device Identification) compliance deadline, Sep 24, 2016. For a comprehensive overlook, you may wish to go through the complex compliance procedures step-by-step for which we would recommend the detailed compliance process. Gear up class II device manufacturers!!


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