FDA Updates Guidelines For Controversial 510k Medical Device Approval Program

New draft guidelines issued for the FDA’s controversial “fast-track” medical device approval program call for manufacturers to assess whether small or major alterations to existing devices could affect their safety and effectiveness. 

The FDA issued a guidance document for manufacturers submitting applications for to it’s 510(k) approval process on August 8. The recommendations, which are non-binding and must still undergo final approval, outlines what manufacturers should do when trying to get a device through the program, and how to decide whether a device qualifies.

Many medical devices are fast-tracked through the FDA’s 510(k) approval process, which allows some devices to enter the market with little to no clinical testing if they are deemed to be “substantially equivalent” to an existing medical device.

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The agency has received criticism for expanding the definition of “substantially equivalent” products, allowing manufacturers to introduce devices through the program, even though they advertise that their product is superior to predecessors, often indicating they use some new technologies or techniques.

Many critics say that since the program’s inception in the 1980s, the term “substantially equivalent” has become nearly meaningless.

At the same time, many medical device manufacturers have been obtaining approval for devices like hip replacements and transvaginal surgical mesh by claiming they are nearly identical to previously approved devices. They have engaged in marketing that extolled the virtues of the devices, claiming that they are vast improvements that utilize “revolutionary” designs or new materials never before used in previous devices.

According to an FDA press release issued late last week, the draft guidance is the first major update to the program’s guidelines since 2011. The guidance recommends manufacturers applying to the program conduct a risk-based assessment on whether modifications to devices could impact their safety and effectiveness.

The guidance also clarifies what kinds of changes to an existing, approved device would trigger a new 510(k) approval requirement, such as label changes, changes to the materials used in the device’s construction, as well as technology, engineering and performance alterations. It also gives some examples of what changes would require a new application and which would not.

“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”

Originally designed for non-critical medical devices, such as band-aids and tongue suppressors, the program has expanded over the years to include numerous medical implants, including surgical mesh, artificial joint implants, defibrillators, stents and other critical devices that are permanently implanted into the human body.

The program has come under increasing fire over the last several years, due to the number of recalls involving 510(k) approved devices, which were only found to carry unacceptable risks after they had already been implanted in thousands of patients.


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