By Nick O’Brien
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:
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:
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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