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What Are FDA Medical Device Reports?

The Federal Food and Drug Administration ensures that various biological products are safe for the public. Medical devices, tobacco products, drugs, food, and cosmetics all fall under the scope of the FDA’s review. While the FDA regulates and verifies that products entering the market are safe, the agency conducts postmarket surveillance as well. The FDA’s initial approval does not guarantee the product is entirely free of dangers and does not absolve the public of risks. Often, a product or device may still present hazards to consumers even once it is available on the market. Therefore, the FDA continues to survey devices postmarket through medical device reports. 

About FDA Medical Device Reports

The FDA currently oversees over 6,000 medical devices nationwide, and the number is always growing. For example, in 2021, the FDA approved twenty-seven new medical devices. Since 1984, medical device report regulations have required firms that have received complaints of device malfunctions, serious injuries, or deaths, to notify the FDA. The FDA defines medical device reporting as a postmarket surveillance tool to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. 

Who Can Submit a Medical Device Report?

It is not only the manufacturer who provides medical device reports to the FDA. The agency divides reports into two classes, mandatory reporters and voluntary reporters. The FDA relies on reports from both categories to monitor medical device safety. Mandatory reporters include manufacturers, device user facilities, and importers. Examples of a “device user facility” include hospitals, ambulatory surgical facilities, nursing homes, or outpatient diagnostic and treatment facilities. These mandatory reporters will communicate with each other and the FDA to track injuries, deaths, and malfunctions. 

The FDA requires these entities to submit reports regarding adverse health events and problems with the medical device. Manufacturers must notify the FDA if their device caused injury or death or if the device malfunctioned. It is important to note malfunctions because these can contribute to injury or death if they recur. 

In addition to mandatory reporters, the FDA encourages voluntary device reporting through its MedWatch feature. The FDA categorizes healthcare professionals, patients, caregivers, and consumers as voluntary reporters. 

What Is the MedWatch Feature?

The FDA urges voluntary reporters to use the MedWatch online voluntary reporting form. By submitting voluntary reports through MedWatch, healthcare providers and patients help the FDA identify unknown risks. The FDA has set up different portals for vaccines, animal products, and tobacco products, but MedWatch pertains to: 

• Medical devices
• Prescription and over-the-counter medicines
• Biologics 
• Combination products 
• Special nutritional products 
• Cosmetics.
• Food

Why Do Medical Device Reports Exist?

The FDA does require testing before they approve a device. Clinical trials and laboratory studies demonstrate if a device is safe or ready for the public. However, the FDA also allows certain devices to receive approval through the 510(k) clearance process. A 510(k) submission demonstrates to the FDA that a device is as safe and effective as a legally marketed device. Yet, while this process introduces more medical devices to help people, it does not subject devices to rigorous safety testing. Therefore, it may introduce unreasonably dangerous devices into the market. 

Regardless of how a medical device secures approval, the FDA keeps all products under observation. Medical device reports are a key step in highlighting defects or risks of medical devices or drugs. Each year, the FDA receives several hundred thousand medical device reports of device-related deaths, serious injuries, and malfunctions. These reports illuminate the risk-to-benefit cost of products. Furthermore, this information can help manufacturers and the FDA decide whether instructions and labeling need updating or if a recall is necessary.