The Food and Drug Administration (FDA) has released a draft guidance on medical device availability, compliance, and enforcement. The draft guidance will help device manufacturers understand the process the FDA uses to assess the benefits and risks factors of proposed medical devices. Better communication between medical device manufacturers and the FDA can help make life saving medical devices more widely available to the public much faster.
The draft guidance reminds device manufacturers the FDA has the authority to limit the availability of any medical devices that are violating the FDA’s guidelines. The FDA also states it intends to enforce compliance with its guidelines and will take any necessary action to do so.
The draft guidance is welcomed by many after a recent study found women’s obstetrical and gynecological devices are significantly less studied than other types of devices. But it’s in manufacturers’ best interest to abide by FDA guidelines for both ethical and financial reasons.
The states of Washington and California have filed lawsuits against Johnson & Johnson and its subsidiary, Ethicon, for misrepresenting the risks of its pelvic mesh which caused severe complications like loss of sexual function, scarring, organ perforation, and chronic pain. J&J has already settled over 20,000 civil lawsuits over the device for $830 million, but is still facing an additional 35,000 lawsuits.
Another J&J device facing scrutiny is its power morcellator, which has a high risk of spreading cancer throughout the body. The device is used in laparoscopic procedures to remove uterine fibroids or benign tumors. However, pieces of tumors can be left behind after using the device, and if these tumors are cancerous, the cancer can spread to other parts of the body.
Current legislation has been introduced to Congress that would help the FDA continue to monitor and respond to potentially defective medical devices. However, while patients everywhere wait for the legislation to pass, a draft guidance reminding manufacturers of their responsibility for producing safe devices is much appreciated.