The U.S. Food and Drug Administration is tasked with reviewing and regulating all new devices that come to market for human use. This ranges from cosmetics to cochlear implants. In order to ensure that a product is safe, the FDA has several processes to clear or approve a new device: 510(k) Approval, De Novo Classification, and Premarket Approval.
Premarket Approval is the FDA’s “most stringent” process for reviewing the medical effectiveness and design safety of a device, designed for Class III devices. The FDA defines Class III devices as “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”
Class III medical devices include all implanted devices such as pacemakers, prosthetics, and breast implants. Devices like defibrillators can also be classified as Class III devices because of how they interact with vital organs like the heart.
Unlike 510(k) devices which argue that they are substantially similar to previously approved devices, Premarket Approval devices are often new and innovative. While that innovation could lead to great strides in medicine, it also presents a totally unknown frontier for side effects and consequences that could arise.
According to the FDA, the actual Premarket Approval application is “a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device.” In addition to having all administrative paperwork completed to the FDA’s satisfaction, Premarket applications will need:
- Good science and scientific writing
- Non-Clinical Laboratory Studies: These include information on the microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests related to the device.
- Clinical Investigations: This information includes the study protocols, safety and effectiveness data, any adverse reactions and complications, all device failures and replacements, patient information, patient complaints, tabulations of data from all individual subjects, and results of statistical analyses.
Once all of this information is gathered, the FDA will analyze whether the dangers, complications and risks are equal to or greater than the potential rewards and benefits the device can grant.
This judgment is not always perfect. In a 2021 study analyzing the rates of recall of Premarket Approval devices and 510(k) approval devices from 2008 to 2017, it was found that out of 310 Premarket Approval devices that passed inspection, 84 were later recalled. That is a failure rate of 27.1%, or put another way, roughly 1 in every 4 devices approved by Premarket Approval between 2008 and 2017 was recalled.
The study does conclude that “high-risk medical devices approved via PMA are associated with a greater risk of recall than previously reported,” but as an observational study, it only acknowledges the existence of a trend and does not delve deeper into why that was the case.
While the Premarket Approval process may not be infallible, it is an important part of a regulatory system that works well in most cases. That does not mean that patients should not try to do their own research.
Before receiving a device from their doctor, patients should ask how long a product has been on the market. The FDA Manufacturer and User Facility Device Experience database can be used to research potentially dangerous devices and see what side effects have been reported.
Above all, patients should try to work with their health care providers and with the FDA to quickly report and address any side effects from the usage of a device.