FDA Medical Device Proposal Threatens Public Safety

(March 29, 2018)  A new FDA medical device proposal threatens public safety, according to attorney David Matthews, who is preparing to try the first Cook IVC filter lawsuit in state court in the country.

The FDA now wants to work with medical device manufacturers to make it easier to get new devices to the market.  What could go wrong?  Plenty has gone wrong in the past.  Some FDA-cleared medical devices have been recalled by FDA; many have been “voluntarily” recalled by the device makers themselves.

For medical devices such as IVC filters, said Mr. Matthews, “the FDA follows the 510(k) ‘substantially similar’ mandate and does not do a safety and efficacy analysis which would be required under a PMA approval process.   Their hands are tied to a certain extent.    We all have to rely on the device manufacturers, and that is an inherently flawed process.”

“The history of the IVC filter provides valuable insight into the shortcomings of medical device approval in the United States,” said a JAMA article published online March 18, 2013.  The doctor authors noted that as the device approval or clearance process currently stands, “there is little incentive for IVC filter makers to embark on [testing] trials that can only eliminate their products’ market share.”

Thousands of Medical Device Problems

Thousands of people have had trouble with medical devices that include transvaginal mesh, metal-on-metal hip implants, knee replacements, IVC filters, hernia mesh, and many other medical devices.  It’s troubling, to say the least, that the FDA now wants to move devices through its review processes even faster.

Device makers argue that they can’t get their useful devices out to people fast enough, that they’re being held back by too much regulation.

Deregulation rules the Day in D.C.

As the Trump administration continues to assert that almost any regulations are bad for the economy, Mr. Trump’s FDA personnel appointments are working to create a new fast-track path to the market for medical devices.  Legal experts, however, say such a move may exceed the FDA’s authority and require some creative reasoning to justify to judges.

FDA Commissioner Scott Gottlieb proposed in December 2017 the creation of a quick route to market for certain products that may not meet the criteria for clearance under the agency’s existing fast-track pathway, known as 510(k).  Mr. Gottlieb said such fast-tracking would foster innovation, though it’s hard to follow his logic, if any logic applies – or matters anymore where corporate profits are concerned.

The fast-track proposal is part of a broader effort by the agency to reduce the amount of clinical evidence required for medical device approvals.  Medical device companies could save millions of dollars and years of development time, if the plan is made law.

510(k) Approval Process
A product cleared under the auspices of 510(k) in current law must show substantial equivalence in materials and intended use to an existing legally marketed device, which is known as a predicate product.  Some 3,000 devices are cleared this way each year, making 510(k) the most common pathway for a medical device to reach the market.

The new FDA proposal would eliminate the need to test a new product against a specific predicate product.  Instead, 510(k) would be replaced by a set of technical standards that would serve as a kind of proxy for the predicate.  The FDA said it would release further details in “non-binding guidance” for industry players early this year.

Mr. Matthews said the agency appears to be changing the law to make it easier for device makers, at the expense of consumers, who need and have a right to expect safe and effective products.

Reuters reported that an expert in medical technology and public health law at the University of Florida, Lars Noah, doubts the FDA plan can hold up under legal scrutiny.

Mr. Noah said, “If somebody with standing wanted to challenge the FDA’s decision in court, a judge is going to say: ‘Show me the predicate.’  I don’t see how the court would side with the agency.”

Abbreviated 510(k)?
The head of the FDA’s medical device division, Dr. Jeffrey Shuren, said in an interview that the move would simply expand on something the agency is already doing with its rarely-used “abbreviated” 510(k) pathway.

The abbreviated route allows companies to show their device meets certain product standards but does not eliminate the need for a specific predicate.  Dr. Shuren said companies in future could show substantial equivalence “to a technology” rather than a product.

In some ways the FDA’s new proposal mimics a frowned-upon practice known as “predicate stacking” in which companies include multiple predicates in their application.  The new product might contain characteristics substantially equivalent to a conglomeration of predicates but not be substantially similar to a single product.

The new fast-track plan makes it appear FDA could now be encouraging stacking, which is hardly ideal, as several devices could be offered as predicates for various features, despite the fact that none may be a true predicate.  It appears the FDA is merely stacking the deck to allow companies to get devices to the market faster, despite a dearth of safety testing and a clear predicate.

The agency is already at work helping companies market digital health products for which the FDA is not requiring approval at all.  Nine companies, including Apple Inc., Roche Holding AG, and Johnson & Johnson will be “pre-certified” based on certain quality and technical metrics to release new digital health products without filing a 510(k) for each.

FDA Medical Device Proposal Threatens Public Safety

“Why is the FDA working with companies to help them waive the statutory obligation to file a 510(k)?” asks Mr. Matthews.  “The 510(k) clearance problems themselves are well documented, and now the FDA is working to help companies sidestep even that clearance altogether? It’s fair to ask whether that agency is working for companies or for people.  It’s fair to ask, for whom does the FDA work, and what are its priorities?”

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