The Institute of Medicine said the current fast-track approval process in the USA for medical devices is unsatisfactory and should be completely overhauled. However, the FDA (Food and Drug Administration) appeared not to be satisfied with the IoM’s (Institute of Medicine’s) recommendation. The FDA had commissioned the IoM in September 2009 to review its medical device process. The FDA medical device unit is said to suffer from high turnover, funding problems, and major recalls.

According to the IoM, 510(k), a term used for the fast-track approval process, does not protect patients adequately enough. However, the recommendations have been criticized because they would raise costs for medical device manufacturers.

The FDA says that it is going to open a public docket so that it can start receiving feedback on the IOM report. It is planning a public meeting, to take place within the next few weeks, to discuss the recommendation of the IoM report, titled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.”

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said:

“We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today. Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them.

FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”

A device maker needs to show that its new or altered product is “substantially equivalent to another legally marketed predicate device” before it can market that product (subject to 510k review).

Congressional actions may be required for some of the recommendations, such as the designing of a new regulatory framework for moderate risk (Class II) devices. However, the FDA reiterates that inputs from stakeholders and others are invited and encouraged regarding the recommendations.

Shuren said:

“Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices. These actions, plus a sufficiently funded device review program, will contribute to a stronger program. Any major modifications made to the agency’s premarket review programs should be based on sound science and through thoughtful and transparent discussion.”

The FDA informs that there had been concerns by various stakeholders regarding the approval process for some medical devices. It responded in September 2009 by undertaking an assessment of its 510(k) program to decide whether any changes needed to be done to make the program better.

The FDA, in a communiqué today, wrote:

“To that end, the FDA committed to an aggressive action plan designed to improve predictability, consistency, and transparency under the existing statutory framework, not only to the 510(k) process but to our device review programs in general.”

The Agency says it has already:

  • Created a draft document explaining when changes to a 510(k)-cleared device which is already on the market needs to be submitted again
  • (Quote) “Taken several steps under its ‘515 Program Initiative’ to address all outstanding “preamendment” Class III device types subject to 510(k) review. The CDRH website includes up-to-date information on the status of each of the 25 remaining device types and the agency plans to complete this process by the end of 2012.”

“FDA: Medical Devices”

“CDRH Plan of Action for 510(k) and Science”

Written by Christian Nordqvist