The U.S. Food and Drug Administration has announced a plan to get medical devices through the federal approval process and on the market more quickly.
According to the Wall Street Journal, the plan is an expansion of the FDA’s Innovation Pathway program.
The report says the plan will weigh factors such as how much risk patients are willing to accept with new devices. It quotes an agency spokesman as saying patients dealing with terminal illness are generally willing to accept a higher level of risk.
Although speed may be beneficial in the context of terminal illness, the FDA has also faced a good deal of criticism recently for approving medical devices too quickly and without sufficient testing.
For example, the agency has scheduled a hearing in June, to evaluate the safety of metal-on-metal hip implants approved as a result of an FDA loophole that allows risky medical devices to go on the market without being safety tested in humans, based on their ostensible similarity to devices already on the market. Thousands of patients have sued over a high early failure rate, and metal particles breaking off and releasing toxic metal ions into the blood.
Transvaginal mesh implants, also approved through the FDA loophole to treat pelvic organ prolapse and urinary incontinence, have spawned similar lawsuits after failing early and injuring patients.
See the report here: https://online.wsj.com/article/SB10001424052702303772904577333941715666550.html