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How does the FDA 'approve' medical products?

You may have seen medical products that claim to be "FDA cleared," "FDA registered," "FDA listed" or "FDA approved" - but what do these labels mean? You would be forgiven for feeling confused.

Though you may see labels on a wide variety of medical products - from implantable defibrillators to smartphone apps - bearing legends such as "FDA registered," in reality, these claims are often disingenuous. But regulation over the correct terminology is rarely enforced.

Class 1, 2 and 3

In truth, the only products that the FDA specifically "approve" are drugs and life-threatening or life-sustaining "Class 3" medical technology (such as defibrillators). These are submitted to a rigorous review process called "pre-market approval" (PMA), to prove that the benefits of the products outweigh any potential risks to the health of the patient.

The only products that the FDA specifically "approve" are drugs and life-threatening or life-sustaining "Class 3" medical technology.

Scientific evidence from clinical trials must be provided by the manufacturers demonstrating the safety and effectiveness of their product. Just 1% of products pass PMA.

Over-the-counter drugs are monitored by the FDA, but they are submitted to a less rigorous testing procedure, especially if they are assumed to be safe.

Vitamins, herbs and supplements are not tested by the FDA unless they are an active ingredient in a drug that requires FDA approval - so manufacturers of supplements are not allowed to claim that their products can treat any specific disease, only that they "promote health."

Despite this, some supplement companies are known to illegally claim their supplements are "FDA approved." It is thought that the FDA are unable to intervene in every instance due to limited resources.

Low-risk medical devices, such as stethoscopes and gauze, are known as "Class 1" and are exempt from FDA review.

"Class 2" medical devices are defined as not life-sustaining or life-threatening, though this category covers a wide spectrum of devices, from X-ray machines to some exercise equipment.

The level of scrutiny attached to Class 2 devices is much lower than Class 3. The devices do need FDA "clearance" before they can be marketed and sold, but rather than submit their products for clinical trial, the manufacturers are required instead to convince the FDA that their products are "substantially equivalent" to products that have been previously cleared by the FDA.

Substantially equivalent means that the device has the same intended use and approximate technical characteristics as an existing product.

Products that pass this clearance process may be referred to as "FDA cleared" or "FDA listed," but this is not the same as "FDA approved," which only relates to the prescription drugs and Class 3 devices that have passed PMA.

This approval method for Class 2 devices has been the subject of mounting controversy. The process is known as "510(k)" - named after its section in the law.

The 510(k) loophole

Although the FDA requests clinical data in about 10% of cases, one concern over the 510(k) system is that testing is insufficient and so products that are either unsafe or ineffective could be released to market.

Under 510(k), devices that have passed clearance, but have later been found dangerous or ineffective and are recalled, are not automatically removed from the FDA's list of cleared products.

Another worry about this process is that the more "substantially equivalent" (but not identical) products are listed, the more a chain grows of FDA-cleared products that increasingly move away from the original product.

But perhaps the most concerning feature of 510(k) is that devices that have passed clearance, but then have later been found dangerous or ineffective and are recalled, are not automatically removed from the FDA's list of cleared products.

This is a loophole that allows any new products bearing the same faults to remain eligible for FDA clearance through 510(k).

In a 2012 report, the Institute of Medicine (IOM) recommended that 510(k) be replaced with an "integrated pre-market and post-market regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle."

But these recommendations - though popular with consumer advocacy groups - were rejected by the FDA.

A congressman (now senator) for Massachusetts, Ed Markey, campaigned for the reform of 510(k) and proposed a 2012 bill to close the loophole.

But the bill was not passed. It received opposition from medical device manufacturers and members of Congress who claimed that the existing FDA review processes are already too time-consuming and unpredictable, compared with other countries, so inserting more safeguards and regulatory steps would have the effect of strangling innovation.

Medical News Today spoke to Dr. Michael A. Carome, director of the non-profit consumer rights organization Public Citizen's Health Research Group, about 510(k).

Dr. Carome cites a report that Public Citizen issued in 2012 highlighting "a concerted lobbying campaign intended to weaken the already lax regulatory oversight of medical devices."

"For example, in 2011 the medical device industry spent $33.3 million on lobbying, raising its total to $158.7 million since 2007. This lobbying campaign has been very successful and has generally drowned out calls for stronger medical device regulation from consumer advocates like Public Citizen."

Carome also sees a second obstacle in the FDA itself, "which has been very resistant to proposals to strengthen or replace the 510(k) system."

"The FDA seems beholden to the medical device industry and the mantra that promotion of 'innovation' is the most important goal in the regulation of medical devices," he adds.

More recently, Sen. Markey wrote to the FDA, appealing directly for them to reform 510(k).

Sen. Markey was satisfied with the FDA's response, announcing in December 2013 that database modifications proposed by the agency "will help decrease the dangers and increase the awareness of medical devices that may be made based on flawed models."

Dr. Carome feels, though, that the FDA's proposed measures "fail to adequately address the underlying flaws in the 510(k) premarket clearance process."

The central issue remains that new Class 2 medical devices found to be "substantially equivalent" to recalled but previously cleared devices are still obliged - by law - to be cleared by the FDA, despite whatever flaws the devices contain.

"The slightly improved transparency provided by FDA's revised database for 510(k)-cleared devices does not close this dangerous loophole in the existing law that threatens patient safety," Carome concludes.

But what are the Class 2 devices that have caused patient safety concerns?

Carome points to the DePuy metal-on-metal Articular Surface Replacement (ASR) hip implant - an "example of a medical device heavily promoted as being innovative and better than earlier types of devices."

In November 2013, DePuy - an orthopedics company owned by Johnson & Johnson - announced a $2.5 billion settlement to resolve more than 8,000 of 12,000 public liability claims filed in US courts after their metal-on-metal hip was recalled in 2010. The ASR was found to shed metallic debris as it wears, causing pain and injury to the patient.

The Myxo ring

In 2008, a surgeon named Dr. Patrick McCarthy at Chicago's prestigious academic medical center, Northwestern Memorial Hospital, was found to be installing a device he had invented - the McCarthy Annuloplasty Ring - into the hearts of cardiology patients without the informed consent of the patients.

"If you are planning to receive a medical device in a US hospital, there is no way to confirm whether the device is FDA approved, investigational or registered," says Dr. Rajamannan.

Concerned patients were even more alarmed when they discovered that the ring had also not been submitted to the FDA for review.

"There are no guideposts for us. You don't learn about this stuff in med school," McCarthy was quoted by the Chicago Tribune as saying, when questioned on why he had bypassed FDA approval.

The ring's manufacturer, a company called Edwards Lifesciences, later falsely claimed that the device was exempt from the 510(k) process and so did not require FDA clearance.

When a concerned colleague of McCarthy's, Dr. Nalini Rajamannan, contacted the FDA, an investigation was triggered, which ultimately saw the ring cleared for use - despite having already been sewn into the hearts of 667 patients.

But further controversy surrounded the FDA's clearance, which simply relied on a clinical study Dr. McCarthy himself had written as evidence that the ring - now rebranded "Myxo dETlogix" - was safe and effective.

Dr. Rajamannan - who was a co-author on that study before withdrawing when she learned that the patients involved were not giving informed consent - later wrote a book detailing the controversy and continues to campaign on behalf of patients installed with the Myxo ring.

Speaking to Medical News Today, she says that the concerns over the Myxo device have still not been addressed by the FDA: "The FDA has written a formal letter stating that they would not be investigating the matter any further. These heart valve rings that are being cleared under the 510k process for Edwards Lifesciences are associated with over 4,000 adverse events and over 645 deaths."

"The other major heart valve manufacturers have less than 20 events for their rings in the FDA database."


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