Article | February 19, 2019

Spotlight: 510(k) – What FDA Changes Could Mean For Medical Device Research And Beyond

By Nick O’Brien

Spotlight: 510(k) – What FDA Changes Could Mean For Medical Device Research And Beyond

Change is afoot in clinical research, and if you listen closely, one of the things you may hear are rumbles from the medical device industry as it undergoes seismic regulatory shifts. These shifts have major implications for clinical trials and eClinical technology, and are largely aimed toward modernizing some of the industry’s biggest institutions – namely, the 510(k) program. At Medrio, we’ve been keeping close watch on how the story develops.

Since 1976, the 510(k) program has allowed medical device companies to go down an expedited approval pathway if they could prove new products were similar enough to a previously-approved predicate. It’s been a useful system for device companies looking to get products approved. But it’s about to undergo significant change: The FDA recently announced a proposal to overhaul this more than 40-year-old clearance process in an attempt to promote greater safety and adapt to the ever-changing medical device landscape. Here’s what you need to know:

  • The FDA took steps in 2018 to begin the transformation process, including a release of draft guidance about the abbreviated 510(k) program.
  • The FDA is striving to push the medical device market toward greater use of new technology.
  • Product safety and product value are key aims of the 510(k) overhaul.

In a recent interview, FDA Commissioner Scott Gottlieb highlighted the organization’s shift towards more forward-thinking: "What we want to do is constantly push the market toward incorporating better technology and better capabilities by advancing the predicates and always looking forward so the...predicates the device companies are using as the basis of their approvals are constantly incorporating newer and better technology to make the devices better and safer."

So what’s on the horizon for the 510(k) program?

The wheels of this transformation have already been set in motion, and the FDA seeks to finalize guidance on this process at the beginning of this year. These will be two of the biggest changes ahead:

  1. Nudging device companies to use more modern predicates - In the new 510(k) approval process, the FDA wants sponsors to base new products on devices that are no more than 10 years old. According to Gottlieb, “Nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than ten years old…[which] means that some devices may not be continually improving.” The FDA is considering sunsetting older predicates citing that during comparative testing, the benefits and risks of more modern technology should be taken into account – older predicates might not be a close enough match.
  2. The Safety and Performance-Based Pathway - The FDA plans to issue a final guidance document to establish this alternative 510(k) pathway for devices that are classified as “well-understood.” According to the FDA’s press announcement, it would allow manufacturers to show substantial equivalence with objective safety and performance criteria instead of comparing the safety and performance of new devices to a specific predicate device. The hope of this pathway is to reduce challenges in demonstrating equivalence between innovative devices and older predicates that may use technology that’s behind the times.

From a clinical research perspective, these changes are huge. Products that could previously win approval based on a predicate may now need to undergo clinical trials. The organizations that make these products may find themselves with a host of new considerations, from CRO outsourcing to eClinical vendor selection. 

If one thing is certain about the future of clinical trials, it is that regulatory and technological change is going to come. Staying on the ball will with changes, like those to the 510(k) program, requires flexibility and adaptability. Choosing eClinical tool vendors that work closely with regulators is a straightforward way for researchers to avoid frustration and setbacks – and ensure a smooth path to serving patients in need.

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