FDA to Overhaul Medical Device Review System

FDA Overhaul of System

“Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices.”

On Monday, November 26, 2018, the Food and Drug Administration announced that it plans to modernize its current process, the 510(k) clearance pathway, which is how a majority of the medical devices are reviewed and approved by the FDA today.

“We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices. In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to the FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances during the last 40 years.”

Changing the 510(k) Process

“As part of the Safety Action Plan, we committed to strengthen and modernize the 510(k) program. This is a pathway used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market – otherwise known as a predicate device.”

“The most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.”

Read the complete FDA press release about the medical device safety overhaul.

While this is good news, unfortunately, it takes time. According to The Associated Press, it “could take years to implement, in some cases requiring new guidelines and regulations for manufacturers. And the most substantive changes could require action by Congress.”

ICIJ Medical Device Safety Investigation

This announcement came just one day after a worldwide investigative report into medical device safety led by the International Consortium of Investigative Journalists. One of the key findings in the “Implant Files” news report says that manufacturers, doctors and others potentially linked more than “1.7 million injuries and nearly 83,000 deaths to medical devices in reports to U.S. regulators over the last decade.”

This is the result of medical devices being approved by basing their design on being “substantially equivalent” to a device already on the market, devices whose design may be outdated.

The metal-on-metal hip replacement designs used by companies such as Zimmer Biomet and Johnson & Johnson give us examples of this. Designs from the 1970s were used to get new metal-on-metal hip replacements approved without any consideration given to the fact that older designs were outdated or scrapped because of severe patient reactions to the metal devices.


Maglio Christopher & Toale, P.A. is leading the litigation against companies like Zimmer Biomet, representing patients who have suffered the effects of heavy metal poisoning from hip replacements, in partnership with Nash & Franciskato..

Questions? Our knowledgeable staff is available at (877) 284-6600.

If you were implanted with a defective medical device, such as a hip replacement, contact us today for a free, no-obligation review of your case.

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