MASSDEVICE ON CALL — Massachusetts Rep. Edward Markey (D) introduced a new bill this week, aimed at limiting the types of devices that are suitable as predicates for new 510(k) applications.
The bill, dubbed the "Safety of Untested & New Devices Act of 2012," would require new 510(k) applications to provide a report on the market status of any devices used to demonstrate "substantial equivalence," including information about corrections and removals of those devices and "each device in the full device lineage" of predicates.
It would also grant the FDA authority to reject claims of equivalence if the predicate device, or its predicates further down the line, had been corrected, removed or were undergoing regulatory action for design flaws.
In addition, if a cleared device is corrected or removed the FDA may ask all devices relying on that device for equivalence to submit audits of their own products to demonstrate that they don’t suffer from the same flaw.
The measure didn’t sit well with the lawyers at FDALawBlog.net, who dubbed it "a solution in a search of a problem."
"The underlying assumption reflected in the bill seems to be that sponsors are rampantly foisting badly designed devices on the public, that they refuse to improve their devices to correct known problems, and that FDA does not now have sufficient statutory authority to prevent the proliferation of badly designed devices," the blog’s authors wrote. "This assumption is not based in reality."
Plastic surgeons in Italy sue over breast implant scare
An Italian surgeons’ group sued Poly Implant Prothese, makers of the sub-standard breast implants at the center of the ongoing health crisis in Europe, as well as Germany’s TUV Rheinland for certifying the implants, Law360.com reported.
Meanwhile, a French government report chided government authorities for failing to heed warnings about anomalies and health risks with the PIP implants that first arose in 1996, according to the Wall Street Journal.
A pacemaker powered by a heartbeat
Aerospace engineers from the University of Michigan developed a prototype pacemaker powered by the vibrations in the chest cavity due mainly to the heartbeat, a potential alternative to today’s devices which require eventual follow-up surgeries to replace drained batteries according to a press release.
Can a blood test tell if you’re depressed?
Researchers accurately distinguished patients with depression from a control group using a blood test that analyzed levels of 9 biomarkers, according to a press release.
"Traditionally, diagnosis of major depression and other mental disorders has been made based on patients’ reported symptoms, but the accuracy of that process varies a great deal, often depending on the experience and resources of the clinician conducting the assessment," study lead and Mass. General Hospital department of psychiatry’s Dr. George Papakostas said in prepared remarks. "Adding an objective biological test could improve diagnostic accuracy and may also help us track individual patients’ response to treatment."