Loopholes Cited in FDA Medical Device Approvals

Advocacy Group Public Citizen revealed eight significant loopholes in how the U.S. Food and Drug Administration (FDA) approves <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices, allowing potentially unsafe, ineffective, dangerous products on the market, said Health Leaders Media.

Of concern are drug-device combinations in hospital use, including drug-eluting stents, MRI machines, heart valves and defibrillators, implantable sheaths and scaffolds, and grafts and intra-aortic pumps, said Health Leaders Media. Congressional action, regulation changes, and FDA practice changes are called for, said Public Citizen. “Discretion has been applied in an expansive manner favorable to industry…. A series of problems with the FDA’s premarket regulation of devices at times appears to permit potentially unsafe or ineffective devices to reach the market. Each must be remedied with a mix of legislative, regulatory and discretionary approaches,” quoted Health Leaders media. The article appears in this week’s Public Library of Science Medicine.

Last year, we wrote that in an effort to improve operations and ease consumer concerns, the FDA announced the creation of the task force to develop recommendations for enhancing the transparency of its operations and decision-making processes. Of note, under the previous administration, the agency was long accused of being corrupt and for a wide variety of issues, conflicts, and failures.

According to Public Citizen, the overarching issue is that the agency reviews medical devices on standards less stringent that those for pharmaceuticals, despite that they can incur similar harm, wrote Health Leaders Media. “We want to raise awareness about structural defects in the medical device approval process that can allow devices to reach the patients despite knowing very little about their safety or effectiveness,” said Jonas Hines, lead author, formerly of Public Citizen, quoted Health Leaders Media.

The authors stress a flaw in the FDA’s 510(k) rule that permits device makers to find a device safe and effective by showing that the emerging device is significantly equivalent to another “predicate” device on the market based on use, said Health Leaders Media. Under current standards, it does not matter if the device is significantly different than the predicate device. Public Citizen called this approval process flaw a “predicate creep.”

“The 510(k) process allows sponsors to identify a predicate device that was itself substantially equivalent to another device that was substantially equivalent to another, and so on. This iterative process permits a scenario in which, over multiple cycles, a new device can be quite dissimilar to the original predicate device—so-called “predicate creep,'” said Public Citizen.

The authors cited eight examples to highlight the eight flaws in the agency’s process, including ReGen’s collagen scaffold. An FDA report last year criticized its own review of the scaffold, calling it “contentious,” quoted Health Media Leaders. “Irregularities included unusual involvement of senior FDA leadership—including the then-FDA commissioner—in decisions usually made at lower levels, a shortened review time” and also noted advisory committee member replacement and a review team likelier to approve the devices, said the authors.

Also criticized were the FDA’s use of the “De Novo Process” which enables a rejected product sponsor to ask for FDA clearance without providing predicate device details if the emerging device is considered “novel” and low-risk; that the agency has not completed regulatory proceedings for 16 percent of the most significantly high-risk devices in existence prior to 1976’s Medical Device Act, enabling them to be considered predicate; that the agency has not risk-classified over 200 pre-amendment devices; and that its “superfluous appeal mechanism” enables device makers another chance for approval following rejecting, said Public Citizen, reported Health Leaders Media.

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