More Medical Device Regulations Needed, FDA Staff Says

Recently, the U.S. Food and Drug Administration (FDA) hosted a meeting to look into the Medical Device Approval program, known as the 510(k), which quickens U.S. approval of some <"">medical devices. Reuters previously wrote that this program could be facing changes. Pre-market notification, or the 510(k) process, is used to review and clear certain medical devices marketed in the U.S. The FDA receives more than
 3,000 510(k) submissions annually.

Now, says the FDA, is confronted with challenges when reviewing specific medical devices saying that expanded regulations might be called for, said Reuters. The agency said the accelerated processes make it difficult to review new products, especially when comparing new products to approved products. Industry had no issue with the current accelerated review process, which was expected.

The FDA noted that determining if there exist sufficient differences with new products when compared to existing products, for potential classification as a completely new product is challenging as are device maker inspections and the glut of newly proposed products, said the Reuters. “Developing clear definitions, guidance, and additional authorities may be required,” said Heather Rosecrans, director of the FDA office that oversees 510(k) reviews, quoted Reuters.

Not surprisingly, industry, consultants to industry, and investors argued against major changes saying that such changes could hamper innovation and emerging technology, said Reuters.

Regardless, many consider the program controversial and moving beyond its original intent, which has led to problems with approved medical devices, noted Reuters previously. As we have written and the Associated Press (AP) noted last year, scientists under former medical device head, Daniel Schultz, claimed, “they were pressured to approve certain products” against their best judgment. It was a nine-scientist letter that added to the call for reform at the agency. Following the letter, a number of lawmakers called on the FDA to investigate the alleged corruption, reported the AP. Schultz who managed the division for five years, ultimately resigned.

Earlier last year we wrote that many critics of the FDA had long complained of safety problems, corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the agency under the former administration. With the Obama administration, new leaders were put in place and safety became an issue of importance at the FDA.

The agency is looking at how to better evaluate medical devices, especially in light of an array of issues with recalled and defective medical devices including heart defibrillators and contact lens solution, to name just two, said Reuters.

Critics argue the process is overused and allows for problems following approval, while industry is concerned about increased review times and costs, said Reuters. Different from the general process, 510(k) reviews do not always mandate clinical data on device use in patients. A mere eight-to-10 percent of accelerated applications contain patient data, said the FDA, reported Reuters.

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