Device makers would no longer be able to claim as predicates for 510(k) submissions devices that have been recalled or are being removed from the market, according to a bill introduced by House Democrats Feb. 1.

The lead sponsor of the bill, Rep. Ed Markey, D-Mass., says the Safety of Untested New Devices Act “closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.” He cites grave health effects suffered by patients from “faulty” medical devices.

Democrats Henry Waxman of California, Jan Schakowsky of Illinois and Rosa DeLauro of Connecticut are co-sponsoring the bill.

Other provisions would task FDA with maintaining a publicly accessible database that firms can reference to determine if a device can be used as a predicate, require FDA and industry to pay more attention to a device’s historical “predicate lineage,” and strengthen company reporting on recalled products.

Rep. Ed Markey, D-Mass.

Office of Congressman Ed Markey

AdvaMed labeled the bill’s requirements “burdensome” and said its provisions are unnecessary.

“We share Congressman Markey’s interest in ensuring the safety and effectiveness of medical devices. However, we believe FDA already has abundant authority to carry out its mandate and the burdensome provisions outlined in HR 3847 will not contribute to patient safety,” said Wanda Moebius, a spokeswoman for the trade group.

FDA Has Previously Raised Issue Of Predicate Restrictions

Markey in his press statement noted that the agency has said it is “concerned that allowing a device to be used as a predicate after it has been removed from the market due to safety problems would place patients at risk.”

The device center’s 510(k) task force floated a proposal in 2010 to issue guidance on when a device “should no longer be available for use as a predicate,” an idea met with resistance from manufacturers that was ultimately referred to the Institute of Medicine committee reviewing the 510(k) process for consideration. IOM declined to specifically address this and six other FDA reform proposals in its July 2011 report. (See Also see "Will Class IIb See The Light Of Day? FDA Sends Mixed Messages" - Medtech Insight, 26 September, 2011..)

SOUND Devices Act

Allows FDA to reject a 510(k) submission that is based on a predicate that has been recalled, or is in process of being removed from the market for major safety problems.
Requires firms to inform the agency if any products in their new device’s “predicate lineage” have caused serious harm.
Instructs FDA to maintain a publicly-accessible database of acceptable predicates.
Strengthens reporting requirements so that companies and the public can more easily determine why a recall occurred.
Calls for FDA to review the safety of high-risk devices if a product in their “predicate lineage” is recalled due to major safety problems.

Source: SOUND Devices Act, Feb. 1, 2012

The SOUND Devices Act is endorsed by the Patient, Consumer and Public Health Coalition, made up of 19 patient and consumer advocacy groups including Public Citizen, the National Research Center for Women & Families and the Union of Concerned Scientists.

In a Feb. 1 letter to House Energy and Commerce Committee Chairman Fred Upton, D-Mich., and Ranking Member Waxman, the coalition cites the ObTape surgical sling for bladder control, associated with adverse events that sparked high-profile lawsuits against former manufacturer Mentor. It was cleared based on a predicate, Johnson & Johnson’s Tension Free Vaginal Tape, which itself had been cleared based on comparisons to the Protegen sling, removed from the market due to adverse events by Boston Scientific in 1999. (See [A#01250110002].)

“Patients suffered needlessly because the FDA does not have the authority to require manufacturers to provide information on the lineage of predicate devices and does not consistently consider that history in making its decisions about 510(k) clearances,” the coalition writes.

Rep. Markey also cited metal-on-metal hips as an example of a troubled class of products that have been cleared based on recalled predicates.

House Democrats on the Energy and Commerce Committee, including sponsors of this bill, have pressed the committee to put more focus on safety risks of devices and the need for stronger oversight. (See Also see "President Cites “Faulty Medical Devices” In State Of The Union" - Medtech Insight, 30 January, 2012..) Sponsors of the bill are currently seeking support for a similar measure in the Senate.

The SOUND Devices Act joins a growing line of legislation addressing FDA medical device issues that have been introduced in recent months, positioned to inform the upcoming device user fee reauthorization process. (See in this issue Also see "FDA Fears Looming Legislation Could Alter Agreement" - Medtech Insight, 6 February, 2012..)

Another bill introduced last week in the Senate is the “Improving Safety, Efficiency & Transparency in Device Regulation Act,” sponsored by Sen. Bob Casey, Jr., D-Pa., and Sen. John McCain, R-Ariz. The bill seeks to streamline the de novo review process by removing a requirement for an initial “not substantially equivalent” decision, mirroring another piece of legislation already introduced in the Senate and one pending in the House. (See Also see "Regulatory News In Brief" - Medtech Insight, 12 December, 2011..)

The Casey-McCain bill would also require FDA to complete the process of reclassifying or requiring PMAs for unaddressed pre-amendment devices. (See Also see "FDA Seeks PMA Requirements For More Pre-Amendment Devices" - Medtech Insight, 15 August, 2011..)

Markey Bill Would Bar 510(k) Clearances Of Devices With Recalled Predicates

More from Regulation

More from Policy & Regulation