FDA Moves Forward With Plans To Make Medical Device Approvals Easier, Faster, Despite Concerns

Federal regulators have announced that they are moving forward with plans to make it easier for manufacturers to get medical devices on the market, despite long-standing concerns over the risk that dangerous devices may be approved, and widely used throughout the medical community before problems or safety issues are identified. 

FDA Commissioner Scott Gottlieb issued a statement on October 24, announcing new steps the agency is taking to relax requirements for medical devices to be sold to healthcare professionals and consumers. The statement came as the FDA issued new draft guidance for policies for a new program meant to speed up the release of medical devices meant to treat life-threatening or irreversibly debilitating conditions.

While the “Breakthrough devices” draft guidance states that the FDA will only grant premarket approval to devices that they believe are reasonably safe and effective, it also notes that it intends to use postmarket data collection to review the devices, which means that the products may be on the market and used in large numbers of unsuspecting patients before problems or design defects are detected.

“In all FDA premarket approval decisions, there is some degree of uncertainty about the benefits and risks of the device,” the guidance states. “The degree of uncertainty that FDA accepts at the time of approval depends on, among other factors, the probable benefits of the device.”

Two other final guidance issued by the FDA focus on helping manufacturers determine when they can apply to the agency’s 501(k) fast-track approval program, which only requires that there be a “substantially equivalent” device on the market to gain approval. The program has been used to introduced numerous products in recent years that were subsequently found to be unreasonably dangerous, requiring recalls after thousands of consumers suffered injuries or had defective devices implanted in their body.

The new guidance comes as a result of the “21st Century Cures” Act, which was passed by Congress last year.

The 21st Century Cures Act sought to ease the way for new medical devices and new drugs, removing regulatory and financial barriers that impede them from getting to the market quickly.

In April, FDA officials published an editorial in the New England Journal of Medicine justifying a possible move away from requiring medical device manufacturers to conduct extensive randomized, double-blind clinical trials, which are considered the “gold standard” for medical research.

Consumer and patient safety advocates have raised concerns about steps the FDA has taken that make it too easy for untested medical devices to reach the market in the U.S. Many devices that are approved based on claims that they are “substantially equivalent” to existing devices, are marketed as featuring superior features, new manufacturing processes, materials, and surgical techniques that have never been seen or used before. Critics warn that the “21st Century Cures Act” will make it even easier for dangerous and defective medical devices to reach the market.

Rolling back regulatory oversight may further erode the ability of the FDA to protect patients from dangerous products, according to consumer advocates. A number of examples in recent years have highlighted the risks consumers face when untested devices are widely adopted in the medical field before dangerous defects are discovered based on post-marketing adverse event reports, essentially making U.S. patients unwilling test subjects.