How to Make Sure My Company’s Medical Device Meets FDA Standards

Getting your company’s medical device ready to bring to market means working to meet FDA standards. The FDA’s regulations help ensure your medical device is safe for the public, and there are various pathways toward achieving approval. The average timeline for medical device development is roughly 3-7 years, though actual production time can vary significantly by product. It does take less time to bring a medical device to market than a new drug, however. The current process for medical device FDA approval was established by the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act.

There are three classes of medical device, with Class III being the most stringent, defined as a device that “supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury.” Class I is “low risk” and Class II is “moderate risk.” Devices in these categories must be petitioned to be downgraded if they only have minor differences from previously approved devices. This fast tracking can radically reduce the timeline for bringing your device to market.

The Fast Track

Drugs in Class III are regarded as ready to go through Premarket Approval (PMA), the most stringent type of device marketing application, before coming to market. This process is required for devices that have no existing equivalent or predicate on the market. However, most devices that make it to market get to go through the fast track, known as Premarketing Notification (510(k)).

Premarketing Notification requires that applicants (companies) demonstrate that their device is “substantially” equivalent to a pre-existing legally marketed device regarding both its safety and effectiveness. The previously approved device must have gone through the PMA or 510(k) processes to be eligible. This system allows for medical devices to get to market much more quickly, but it also introduces an element of risk due to the quick turnaround time and assumed equivalence.

With no regulations on how old previously approved devices can be and exceptions for Humanitarian Devices and Investigational Devices, the current 35-year-old system may not still be safe for consumers. These concerns led the Institute of Medicine (IOM) to recommend eliminating the 510(k) process altogether in their July 2011 FDA-commissioned report. The report argues that current 510(k) process doesn’t ensure device safety or effectiveness because that’s not what it’s designed it do. It merely determines whether a new device is a predicate, nothing more or less.

The Danger of the Fast Track

With the current 510(k) system, a relatively small number of devices go through PMA. Even if the primary predicate is recalled, it’s difficult to remove the subsequently approved products from the market unless they’ve been found to be harmful. Furthermore, the FDA spends much less time approving products that go through 510(k) vs. PMA. In 1996, the U.S. Supreme Court found that the FDA spent more than 1200 hours on a PMA request vs. just 20 hours on average for a 510(k) submission. It was in the best interest of the FDA and medical device companies to submit 510(k) requests for expedited results, disregarding consumer safety.

It often takes years for the FDA to recognize device danger, such as in the case of the Stryker and Depuy replacement that caused heavy metal poisoning in almost half of those who received an implant. By increasing device testing, including requiring more devices to go through PMA, the FDA could improve the safety of new medical devices going to market.

Don’t Wait for FDA Testing—Ensure Your Device’s Safety

With the help of a medical device testing lab like Avomeen, you can help ensure your company’s medical device is safe before you even go through the FDA approval process. Work with the experts at Avomeen to perform materials analysis, stability testing, extractable and leachable testing, formulation and process development, and so much more.