FDA Overhauls Widely Criticized Medical Device Approval Process

The Food and Drug Administration (FDA) announced plans to overhaul the nation’s medical device approval process. Opponents have long criticized the process for its failure to catch problems with risky implants and other medical products. The FDA wants to make sure new medical devices reflect up-to-date safety and effectiveness features.

Under current standards, manufacturers can launch new products based on similarities to decades-old products instead of new clinical testing.

The FDA announcement came one day after the publication of a global investigation into the safety of medical devices by more than 50 media organizations. The International Consortium of Investigative Journalists found that more than 1.7 million injuries and nearly 83,000 deaths were suspected of being linked to medical devices reported to the FDA over a 10-year window.

Modern approvals have fallen under guidelines adopted in 1976 under the Medical Device Regulation Act. Commissioner Scott Gottlieb took to Twitter to discuss the agency’s 510(k) process—the process responsible for clearing low to moderate risk medical devices. These devices include:

• Imaging scanners
• Computerized drug pumps
• Artificial joints
• Spinal implants

“We believe that it’s time to fundamentally modernize an approach first adopted in 1976,” Gottlieb said in a statement.

Why has the FDA approval process been criticized?

Current standards clear more than 95 percent of medical devices for the U.S. market. Medical devices don’t have to go through the rounds of testing like new drugs. Instead, devices only have to show that they are similar to devices already on the market. On the other hand, new pharmaceuticals go through several rounds of testing, including patient studies before becoming available for patient purchase.

A very small portion of truly new medical devices must undergo clinical testing to verify safety and effectiveness.

Dr. Challoner, a leading expert on the FDA’s approval process, believes Congress originally intended for the streamlined process to be a temporary path to grandfather in thousands of low-to-moderate risk devices. However, instead of phasing out this expedited process, it became the principal path to approval.

When will the FDA’s device approval reforms begin?

Some of the FDA’s reforms will take years to implement. In addition, these reforms may call for new guidelines and regulation for manufacturers and the most substantive changes could require actions by Congress. In modernizing the approval process, the FDA wants to nudge companies to base products on devices that are no older than 10 years old.

However, some experts worry that the medical device industry’s lobbyist may derail reform efforts.

“If the device industry comes back at this full bore with their lobbying efforts, this could all die a slow and painful death,” Dr. David Challoner said.

However, the medical device industry’s chief lobbying group said that it looks forward to learning more about the FDA’s plans.

“While we believe the 510(k) pathways has proven its effectiveness over the years, we have always maintained that any process can be improved,” the group said in a statement.

The Carlson Law Firm Can Help

Medical devices should improve the lives of patients. However, many of these devices have not undergone extensive testing and have led to millions of serious injuries and thousands of fatalities. Contact The Carlson Law Firm to discuss your situation with a qualified Medical Device Injury Attorney.

We are ready to evaluate the facts of your case to help you determine your next steps. Call us today to schedule a free, no-obligation consultation.

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