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Thousands of lawsuits have been filed over the past several years concerning allegedly defective medical devices such as metal-on-metal hip implants and transvaginal mesh. Critics of these devices point to the FDA’s fast-track 510(k) approval process as being partially responsible for allowing these devices onto the market without adequate clinical trials.

In an effort to make the data concerning medical devices more available to the public, Representative Edward Markey (D-Massachusetts) and Senator Jeff Merkley (D-Oregon) have sent a letter to the FDA. In the letter, they ask about the FDA’s willingness to make changes to the 510(k) premarket notification database. The lawmakers requested answers to their questions by September 19, 2012.

What is the FDA’s 510(k) Process?

In order to market a new device in the U.S., a manufacturer must gain FDA approval either through the premarket approval (PMA) process, or through the premarket notification, also known as the 510(k) process. Most medical devices, including hip implants and transvaginal mesh, are cleared through the 510(k) process.

To gain 510(k) approval, a company need not perform human clinical studies to prove a product’s effectiveness and safety. Instead, they need only show that the device is ”substantially equivalent” to another device that’s already on the market. Unfortunately, the new device may be flawed, but it escapes rigorous examination through the 510(k) process. In some cases, even the predicate device was flawed and recalled because it was found to cause too much harm.

IOM States 510(k) Too Flawed to Salvage

In 2011, the Institute of Medicine (IOM) recommended that the FDA replace the 510(k) process with a new approval system. In the report, the IOM states that the 510(k) process cannot properly determine the safety and effectiveness of medical devices. The report goes on to criticize the 510(k) process by noting that it was never intended to screen out dangerous or ineffective products.

A study published in Archives of Internal Medicine found that 71 percent of high-risk medical devices recalled between 2005 and 2009 were cleared through the 510(k) process.

FDA Willing to Make Changes?

In February 2012, Congress introduced legislation that would permit the FDA to reject an application for a new device if it’s modeled after an earlier product that was found to cause harm. The bill remains pending so Congressmen Markey and Merkley sent their letter to the FDA to assess the agency’s willingness to make changes.

In their letter, the lawmakers note the apparent problems with the 510(k) process. They state that “a flaw in the 510(k) process opens the door for defective devices to make their way onto the market and jeopardize patient safety. Current law requires FDA to clear a device shown to be substantially equivalent to a predicate, even in cases where the new product contains the same flaws as an earlier model that had to be recalled by the manufacturer….”

The Congressmen go on to state that providing manufacturers, healthcare professionals, and the public with better information concerning recalled devices could help avoid future injuries. They ask if the FDA would be willing to update the 510(k) database to:

  • Indicate devices recalled for design flaws
  • Update the database within 30 days after reviewing a manufacturer’s root-cause analysis determining a flaw leading to a medical device recall was serious
  • Include clearly marked past recalls
  • Notify the public that a product repeats design flaws that caused an earlier product’s recall

The lawmakers also note that some devices currently used in patients, such as transvaginal mesh implants, can trace their clearance back to a product that had to be recalled for a serious design flaw. “These database improvements would enhance the transparency of the 510(k) process and help manufacturers avoid using recalled devices as predicates that may put their own devices at risk for future enforcement actions.”

One Comment

  1. Gravatar for Denise Jacobs

    As a nurse and patient injured by a product on the market by the FDA's flawed and antiquated 510(k) process, I feel very strongly that the FDA must make these changes to promote patient safety, and do this as soon as possible, before thousands more are injured by these defective medical devices.

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