The FDA’s Center for Devices and Radiological Health (CDRH) has traditionally relied on several authorities and approaches in its postmarket surveillance program. Each of these activities represents a key piece of a larger postmarket surveillance system:
- Medical Device Reporting (MDR): Each year, the FDA receives several hundred thousand medical device reports of confirmed or possible device-associated serious injuries, deaths, and malfunctions. While MDRs are a valuable source of information, this passive surveillance system has notable limitations, including the potential submission of incomplete or inaccurate data, under-reporting of events, lack of denominator (exposure) data, and the lack of report timeliness. MDRs are housed in the Manufacturer and User Facility Device Experience (MAUDE) database.
- Medical Product Safety Network (MedSun): MedSun is an enhanced surveillance network comprising approximately 280 hospitals nationwide that work interactively with the FDA to better understand and report on device use and adverse outcomes in the real-world clinical environment. Specialty networks within MedSun focus on device-specific areas such as cardiovascular devices (HeartNet) and pediatric intensive care unit devices (KidNet). In addition, the network is used for targeted surveys and focused clinical research.
- Post-Approval Studies: The FDA may order a post-approval study as a condition of approval for a device approved under a premarket approval (PMA) order. Typically, post-approval studies are used to assess device safety, effectiveness, and/or reliability in the real-world setting, including long-term effects. The PAS can also be used to assess the learning curve, effectiveness of training programs and how well device performs in certain groups of patients. CDRH maintains a list of post-approval studies.
- Postmarket Surveillance Studies: The FDA may order a manufacturer of certain Class II or Class III devices to conduct postmarket surveillance studies (often referred to as “522 studies” for section 522 of the Food, Drug and Cosmetic Act). Study approaches vary widely and may include non-clinical device testing, analysis of existing clinical databases, observational studies, and, rarely, randomized controlled trials. CDRH maintains a list of 522 studies.
- FDA Discretionary Studies: In addition to medical device adverse event reports, post-approval and postmarket surveillance studies, the FDA also conducts its own research studies to assess device performance and clinical outcomes, investigate adverse event signals and characterize device-associated benefits and risks for patient sub-populations. A variety of privacy-protected data sources are used including national registries, Medicare and Medicaid administrative and claims data, data from integrated health systems, electronic health records, and published scientific literature.
While diverse in their approach all of these activities share one common goal: to improve the safety and effectiveness of current and future medical devices.