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Insurance Companies Question Safety of 510(k) Process

Brian Buntz

April 16, 2015

4 Min Read
Insurance Companies Question Safety of 510(k) Process

An insurance lobbying group argues that the pathway should be limited to a narrow set of medical devices.

Brian Buntz

America's Health Insurance Plans (AHIP), a prominent insurance lobbying group representing 1300 insurance companies, is pushing for changes to FDA's premarket regulatory submission process. AHIP is arguing that the agency's clearance of products such as laparoscopic power morcellators under the 510(k) pathway point to flaws in its ability to ensure the safety of medical devices.

Once used for roughly half of hysterectomies in the United States, morcellators are thought to unwittingly spread cancer cells throughout the body in some cases. FDA has warned that the vast majority of hysterectomy and myomectomy should not be treated with the devices.

FDA cleared the first power morcellator in 1991 via the 510(k) process. The agency would go on to clear 10 of the devices via that pathway and, over the years, the devices became widely used for a variety of surgical procedures, with five companies marketing the devices on the U.S. market. In April 2014, FDA formally discouraged the use of power morcellators for hysterectomy or removal of uterine fibroids, stating: "If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival." It updated its warning in November 2014.

AHIP is criticizing both FDA's process for clearing devices via the 510(k) pathway as well as its post-market surveillance capabilities, arguing that the agency's handling of the power morcellator scare was insufficient and that FDA should have reviewed clinical data related to the devices before clearing them for use.

The notice from AHIP was partly triggered by Sen. Bob Casey, D-PA, who in March of this year pressured insurance companies to restrict coverage of the devices.

Three of the four largest insurance companies would go on to end coverage of hysterectomies using the devices.

AHIP is hoping the agency will beef up the premarket scrutiny of the 510(k) process.

Similarly, JAMA released a study last year that concluded the 510(k) process lacked sufficient evidence to show medical devices are safe and effective.

In 2011, the Institute of Medicine (IOM) reached a similar conclusion, but advocated that the entire pathway be scrapped and replaced with a new framework.

After the IOM released that report, the agency released a statement defending the 510(k) pathway, stating that it needed modernization rather than replacing. "FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," explained CDRH director Jeffrey Shuren, MD at that time in a statement.

AHIP's criticism of the 510(k) process is not new. In 2007, it published a document titled "Setting a Higher Bar" that advocated that the pathway "be tightened by narrowing the range of medical devices" that can be cleared under it. In addition, it recommended restricting the amount of changes that could be made to devices to qualify for the 510(k) pathway.

Since the 510(k) was established under the Medical Device Amendments of 1976, FDA has deemed that the majority of non-Class I medical devices are eligible for the pathway, reserving the more stringent PMA pathway primarily for devices that represent a high risk or whose design is considerably unique or complex. The original Amendments did not define the notion of substantial equivalence, opening the door for many medical devices to piggyback on earlier devices on the market.

In related news, the FDA has responded to the criticism from the industry and others that it is too slow to clear innovative medical devices by debuting what it calls an Expedited Access Program (EAP), which could help the sickest patients receive earlier access to novel life-saving medical technology. 

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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