5-Aug-10 1:00 PM  CST

FDA Proposes Stronger Medical Device Regulations

In a push to increase patient safety, the FDA has proposed stronger regulations in the approval process for drug infusion pumps and other medical devices.
The proposal is part of the agency’s effort to overhaul the 510(k) process, a process called premarket notification. Under the 510(k) process, manufacturers only have to provide enough information on the device to prove that it is substantially equal to a device that is already on the market. Under the proposed regulations, however, manufacturers would have to submit all the information they have about the safety and effectiveness of their devices no matter what. The FDA hopes the new guidelines will strengthen its ability to revoke approval for products that prove unsafe or ineffective before they reach the market.
“Taken together, these preliminary reports show a smarter FDA—an agency that recognizes both sides of our mission to protect and promote public health,” said CDRH Director Dr. Jeffrey Shuren, M.D. in a news release. “The agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices.”
The 510(k) system was originally created to help routine medical devices (considered Class I and II devices), such as x-ray machines and infusion pumps, that are well known and understood reach the market in a simpler, less costly process.  It is different from the more stringent premarket approval process (PMA), which is reserved for newer, more complicated devices considered “novel” or Class III devices.
Medical professionals, lawmakers and other federal agencies have complained that the 510(k) process is a loophole that manufacturers can use to market new technology under the guise of previously approved devices without issuing the proper safety information. According to a guidance report released in April, the FDA has also seen a rise in the number of recalls involving medical devices, infusion pumps in particular, since 2005. One of the most recent incidents was a massive infusion pump recall in May. Medical device manufacturers have also complained that the 510(k) process is unpredictable and inconsistent. They also believe that the FDA is not being transparent enough on the 510(k) process and how it is supposed to work.
“In establishing device classes in 1976, Congress envisioned that all Class III devices would eventually be required to undergo premarket review through the more stringent PMA process, which requires the manufacturer to provide evidence, which may include clinical data, providing reasonable assurance that the new device is safe and effective,” the Government Accountability Office said in a report issued in 2009. “We are recommending that the Secretary of Health and Human Services direct the FDA Commissioner to expeditiously take steps to issue regulations for each Class III device type currently allowed to enter the market through the 510(k) process.”
In addition to stricter safety regulations, the FDA proposed creating guidance documents that clearly define what constitutes a Class I, II or III medical device. It also proposed creating a public database to make the medical device approval process more transparent. The database would include up-to-date labeling and photos as well as summaries of review decisions by the Center for Devices and Radiological Health, the department that regulates medical devices on the market.

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Source: NPTANews  

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