FDA’s New Policy Loosens Medical Device Approval Process

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More than 200 types of medical devices and testing products are newly exempt from safety and effectiveness reviews according to a Food and Drug Administration (FDA) policy that went into effect Dec. 30.

FDA’s end-of-year order lessens the burden of premarket review and associated costs for medical device and test manufacturers, as reported by MedTech Dive.

The sweeping exemption covers a range of common devices used in major medical specialties, including cardiology, gynecology, urology, gastroenterology, ophthalmology, radiology, plastic surgery and neurology. Examples of newly exempt devices, which the FDA has identified as low risk according to MedTech Dive, include components of a shunt used in brain surgery and a colposcope, a viewing device for detecting early signs of cervical cancer.

Only Class I or Class II devices, which the FDA considers less risky than Class III devices, are included. FDA approval for Class I and Class II devices involves the agency’s less stringent 510(k) “premarket notification” or “premarket submission” process. This process requires medical device manufacturers to give the FDA 90 days’ notice of their plans to begin marketing a new or modified medical device. Under 510(k), device manufacturers can obtain FDA approval by showing that their new or modified device is “substantially similar” to another already approved device. This stands in contrast to the Class III device approval process, which requires new clinical research on each proposed device.

But the FDA has now exempted dozens and dozens of tests and devices from the 510(k) review process under the new rule.

Why Did the FDA Exempt So Many Medical Devices?

The FDA explained the rationale behind the new rash of exemptions in the body of the rule:

“FDA’s determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.”

But patient advocates, who already fear that the 510(k) process is too lax, suggest the FDA may be shirking its medical device safety watchdog responsibilities.

“The bottom line is that the FDA has decided that there are many more devices that can be sold without any scrutiny at all,” Diana Zuckerman, president of the National Center for Health Research, told MedTruth in an email.

Under the 510(k) process, a new medical device could potentially be approved for market even if the comparative review was based on a device that was eventually recalled or found to be defective.

To compound this issue by exempting scores of devices from any regulatory scrutiny is, according to Zuckerman, “dangerous for patients, and puts doctors and patients in a situation where they should be afraid to try any new devices that have been exempted from even the most basic FDA standards.”

“And it is unfair to device companies whose leadership takes pride in their higher standards,” she said.

Exemptions Tied to Controversial 2016 Law

The FDA pinned the broad exemptions on the 21st Century Cures Act, a 2016 law that put new procedures in place designed to accelerate medical product development and deliver potentially life-saving cures to patients more quickly.

Zuckerman, however, told MedTruth that the Cures Act didn’t require the FDA to make “so many exemptions, but the act has encouraged the FDA to lower its scientific standards for devices and drugs.”

“Many members of Congress who voted for the bill did not realize how devastating the impact would be on patients, physicians, and on FDA’s reputation as a ‘gold standard’ for safety,” she told MedTruth.

However, good news may be on the horizon. Zuckerman believes the recent appointment of Dr. Stephen M. Hahn as FDA commissioner might reverse this trend.

By Nicole Knight

Nicole Knight is a freelance writer based in Southern California. A former reporter for the Orange County Register, she most recently covered issues related to women’s health and economic justice for the nonprofit site Rewire.News. Her bylines have appeared in outlets ranging from Pacific Standard to Parents.com, reflecting her varied interests. She is a member of the Association of Health Care Journalists and the American Society of Journalists and Authors. Follow her on Twitter @ nicolekshine.

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