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FDA Approval Process

Every year, Americans spend approximately $150 billion on medical devices, which include knee and hip replacements. Joint replacement surgeries alone top 1 million every year, and that figure is growing.

Hip and knee replacements, developed through physician and industry partnerships, are among the most common. These devices are subject to the approval of the U.S. Food & Drug Administration (FDA). Unfortunately, industry lobbyists have been largely successful in fast-tracking the approval process.

Boston injury lawyers at The Law Offices of Jeffrey S. Glassman know this has been to the detriment of patients across the country. When medical implants are not properly tested and vetted, it can result in a substandard product that may fail prematurely and could also result in a host of adverse side effects, such as metal poisoning. Often, treatment involves invasive, painful corrective surgeries.

In such cases, patients may seek redress from the manufacturer and/or distributor via litigation.

While FDA representatives have stated the current device regulatory system is appropriately restrictive and “has served patients well,” Consumer Reports notes that for many implants and other high-risk devices, manufacturers do little more than file some paperwork and a user fee of $4,000 to start selling these devices to the public. The only real “testing” that occurs is on unsuspecting patients.

While this may result in hundreds of joint replacement product recalls annually, manufacturers ultimately find this more cost effective than properly testing these products in advance.

What is a Medical Device?

Medical devices, as defined by the FDA, are those that:

  • Diagnose, cure, lessen, treat or prevent diseases;
  • Affects function or structure of body;
  • Doesn’t achieve primary intended purpose through chemical action.

Such products are overseen by the FDA Center of Devices and Radiological Health. This is the branch that is supposed to oversee the design, manufacture, repackage, relabel and/or import of medical devices into the U.S. The agency doesn’t regulate physicians. Instead, it regulates manufacture and distribution of the actual devices.

FDA Regulation of Medical Devices

The FDA was first granted authority to ensure effectiveness and safety of medical devices – and prevent fraud – via the Medical Device Amendments of 1976. This was an amendment to the Federal Food, Drug and Cosmetic Act.

This measure established three regulatory classes for medical devices. The most highly-regulated of these is Class III, which are devices that support or sustain human life or are essential to one’s health or unreasonable risk of injury. All Class III products are subject to premarket approval requirements, which necessitates scientific review to ensure effectiveness and safety.

Many joint replacement devices – including metal-on-metal hip implants – are Class III products because of the fact they are high-risk and involve load-bearing joints. Others are Class II products, which includes things like contact lenses and wheelchairs, can be approved so long as it’s proven they are similar to other devices already on the market. Class I devices, which would include things like dental floss and bandages, have to be registered, but typically don’t require premarket review.

One major problem, though: The FDA gives companies some freedom in classifying their own devices. In one instance, according to The New York Times, manufacturer OtisMed, maker of the OtisKnee, told doctors and hospitals that their knee-cutting guides for surgeons were Class I devices, that didn’t need FDA approval. The company worked closely with Stryker, which made knee replacement devices. OtisMed later paid $80 million in criminal civil fines for selling 18,000 unauthorized medical devices for three full years without FDA approval.

Most devices obtain FDA approval through one of the following pathways:

  • Investigational Device Exemptions
  • Pre-market Notification (510(k))
  • Pre-market Approval Application
  • Humanitarian Device Exemption

What we see more commonly is companies taking advantage of the Pre-Marekt Notification (510(k)) process.

Pre-Market Notification (510(k)

This is required when demonstrating substantial relevance to a legally-marketed device or when making significant modifications to a marketed device. In other words, applicants need only show their device is comparable to one or more similarly-marketed devices already on the market.

While all Class III products are supposed to undergo rigorous clinical testing, this pathway allows manufacturers to sidestep all that.

In order to be deemed substantially-equivalent, a device must have the same intended use and technological characteristics of the “predicate,” or other legally-marketed device.

When a medical device maker can obtain FDA approval through the 510(k) premarket notification program, they can avoid undergoing premarket testing or clinical trials before being used in patients. All they have to do is state their products are significantly similar to one already on the market.

This kind of “grandfathering in” of Class III devices is intended to quickly give patients access to the newest technology. However, failure to properly test these products before they are mass-produced has proven to result in the implantation of devices that are both defective and dangerous.

If you have been injured by a defective hip replacement or faulty knee replacement, we can help.

Contact the Law Offices of Jeffrey S. Glassman today for a free and confidential consultation.

Call (617) 367-2900 – NO FEE UNLESS SUCCESSFUL
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