The first quarter of 2018 witnessed the largest increase in medical device recalls in more than a decade. In spite of this the FDA has decided to lessen restrictions on certain medical devices.
Prior to the passage of the 21st Century Cures Act in December 2016, industry experts had called on the regulatory agency to increase their oversight concerning the medical device industry. The Century Cures Act ignored the advice of experts and paved the way for the FDA to exert less oversight rather than more.
Proponents of the CCA argue that looser restrictions allow the public access to potentially life-saving medical devices. It’s a nice sentiment but the facts don’t bear this out. The FDA has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).
As the FDA exempts itself from regulatory decision making, the public is not able to trust the efficacy or safety of medical devices. The “Wild West” atmosphere of the new medical device industry only helps manufacturers seeking an increase in profits by expanding their product lines in potentially new and dangerous ways.
The 21st Century Cures Act is a step beyond and decidedly in the wrong direction from the already controversial 510(k) approval process. The 510(k) system is a controversial program. Most medical devices available in the U.S. received FDA clearance through the 510(k) process. It’s been called “the weakest and most nonsensical program in the FDA.” The Institute of Medicine issued a report in 2011 calling the process flawed. The report said the program should be scrapped and replaced. The government made no changes in response to the report. But the government has continued to reduce its burden on manufacturers. In other words, the weak program has been made weaker. Under 510(k), manufacturers don’t need to perform clinical trials. They don’t need to submit data proving that devices are effective or safe. The companies only need to show that the devices are “substantially equivalent” to devices already on the market.
Those who require medical devices are now left in the dark about their efficacy and safety and the governmental agency in charge of ensuring this has abdicated their responsibility with the blessing of our elected officials.
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