Senators Propose Expanding Post-Approval Device Tracking

Senators propose new post-approval tracking requirements for medical devices.

According to lawmakers, the new rules would create higher standard for devices approved through the 510(k) system, which now requires companies only to show their devices are similar to those already on the market. The legislation would allow the U.S. Food and Drug Administration (FDA) to require post-market clinical studies of medical devices approved through the 510(k) review process if they pose potential safety risks. The bill also would give the FDA new authority to provide conditional clearance with required safety studies for devices approved through the regular 510(k) process.

“Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients,” said Sen. Herb Kohl (D-Wis.), one of the bill’s three sponsors, in a statement. “This legislation will help ensure that FDA can act quickly and decisively when there’s a problem and that the drive toward getting new technologies to market won’t come at the risk of patient safety.”

The legislation was introduced by Kohl, Charles Grassley (R-Iowa) and Richard Blumenthal (D-Conn.).

“Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices—causing significant costs to our economy as well as health,” Blumenthal said in a news release.

The senators have sent letters to five companies that recalled faulty medical devices requesting information about how the companies conduct post-market surveillance and manage recalls, including New Brunswick, N.J.-based Johnson & Johnson’s DePuy division (for its recently recalled metal-on-metal hip system); Minneapolis, Minn.-based Medtronic Inc.; and Murray Hill, N.J.-based CR Bard Inc.

While the agency can order some post-approval reviews now, its authority has limits. For example, the agency can’t require long-term studies as part of 510(k) approvals.

The Washington, D.C.-based Advanced Medical Technology Association opposes expanding the FDA’s post-market device authority because it is unnecessary, according to Janet Trunzo, executive vice president for technology and regulatory affairs.

“We believe expanding the FDA’s authority to require post-market studies as a condition of 510(k) clearance is unnecessary given the agency already has broad authority to require manufacturers to conduct post-market studies for higher-risk devices cleared via 510(k),” she said. “Regarding the bill’s provisions to implement recent Government Accountability Office’s (GAO) recommendations to improve the FDA’s handling of medical device recalls, we believe, consistent with GAO recommendations, the FDA could do more to enhance the clarity and consistency of its recall process, and we are pleased that the agency has a number of initiatives underway in this area.”

Trunzo noted that several recent studies have shown that for the vast majority of products cleared by the FDA, less than 0.5 percent are involved in a serious recall.

“In addition, nothing in the GAO’s recommendations suggest a lack of diligence or inadequacy in medical technology companies’ implementation of recalls,” she added.
The legislation should be included in reauthorization of the FDA’s medical device user fee program that helps fund the review process, Grassley said. The program comes up for reauthorization in October.

Consumer advocates have criticized the FDA not being vigilant enough, but device companies claim that new product reviews are taking too long.

“Our mission is to protect the public health,” Shuren told Bloomberg news during an analysts meeting in New York, N.Y., on Dec. 14. “But it’s also to promote public health by promoting innovation. There’s this misperception out there that the two are inconsistent but we think they are very compatible.”