The U.S. Food and Drug Administration (FDA) needs to make some changes according to The U.S. Institute of Medicine (IOM) after 35 years of the same, and a report will be released this week that hopes to change the way medical devices are regulated by the agency. The fast-track 510(k) process of device approval, under which most medical devices reach the market, is at the forefront of the pending discussion.

The US FDA requested document is expected to recommend that medical devices such as artificial joints and pacemakers go through a more rigorous approval process before reaching the market.

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k).

This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.

Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

Consumer advocacy groups have been critical of FDA oversight of medical devices, arguing that they typically have been cleared too quickly.

Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group said:

“FDA’s oversight and review process is too weak and needs to be strengthened. We believe that the process for approving devices under the 510(k) program frequently is deficient because of the application and the loose interpretation of what it means to be ‘substantially equivalent to a predicate device.'”

A minority of higher-risk devices, such as implanted heart defibrillators, have to go through a more rigorous approval process, not unlike that required for new drugs. Patient-safety advocates say that too many devices are cleared under the 510(k) program, which is too lax to begin with.

Mark Leahey, president of the Medical Device Manufacturers Association pushes back however:

“We remain concerned about efforts to overhaul a regulatory pathway that would create additional uncertainties and slow patient access to medical therapies. Moving forward, we will continue to work with FDA and all stakeholders to ensure a more predictable and reasonable process is in place.”

The IOM report follows several widely publicized recalls of devices, including the recall last year of two artificial hip systems that had been implanted in almost 100,000 patients.

The report may also address drug approvals. Currently, the main consumer watchdog in this system is the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). The center’s best-known job is to evaluate new drugs before they can be sold. The center’s evaluation not only prevents quackery, but also provides doctors and patients with the information they need to use medicines wisely.

CDER ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks. drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling.

If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale. The center doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

Written by Sy Kraft