The report, "Medical Devices and the Public Health: The FDA 510(k) Clearance Process at 35 Years," could, in fact, ultimately have a chilling impact on innovation to all sorts of nonwovens including feminine hygiene products (tampons and pads); single-use surgical drapes; single-use surgical gowns and other operating room apparel; bandages and other types of wound dressings -- virtually all of which are classified as either Class I or Class II medical devices under U.S. law.
At issue is a process known as 510(k) clearance that has been used by the US Food and Drug Administration (FDA) for more than three decades to determine whether products which are classified as medical devices under the Federal Food, Drug, and Cosmetic Act (Title 21, United States Code, Section 301, etc.) have a "reasonable assurance of safety and effectiveness" before they can legally be sold in the United States. The term 510(k), refers to a specific section under the Act.
3M, Cardinal Health, Kimberly-Clark, Molnlycke Health Care, and P&G have utilized the 510(k) clearance process repeatedly over the past few years as a means of requesting FDA approval to bring a new/improved medical device to market in the United States. But according to the IoM, many of these 510(k) applications – especially for Class I and Class II medical devices – are based on manufacturer assertions that the new/improved product is, in fact, "substantially equivalent" to a similar device that has already been approved by FDA.
The report further notes that some of the products to which equivalency is claimed were never actually proven to be safe and effective under current definitions because they were legislatively "grandfathered" in as being safe and effective when Congress wrote the underlying laws, and some of the "equivalent" devices are no longer even for sale on the US market.
And while a quick glance at the FDA 510(k) database indicates just how competitive this market is for members of the nonwovens industry – over the past five years, for instance, the FDA has approved twenty different 510(k) applications for tampons, seventeen for single-use surgical drapes, and twenty two for single-use surgical gowns – FDA asked IoM in 2009 to take a look at the process due to medical device manufacturer complaints that gaining 510(k) clearance has become "...too burdensome and time-consuming and that it is delaying new medical devices from entering the market."
Now, after a two-year review which included several public meetings and comment opportunities in which most participants anticipated IoM would eventually recommend little or no change to the existing system, comes the bombshell. A 280-page report that concludes, among other findings, that FDA's 510(k) clearance process is "flawed" and "does not reward innovation."
Even more dramatic, the IoM committee tasked with leading this effort recommends that the existing clearance process, in place for decades, should basically be pulled out by the roots and replaced with "an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle."
Interestingly, shortly after the report was released, Jeffrey Shuren, director of the FDA division responsible for approving medical devices, said, the "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."
To that end, the FDA is accepting public comment on the IoM report until September 5, 2011. Comments can be submitted electronically through www.regulations.gov (type 2011-19353 into the search engine on the home page), or via mail addressed to:
Division of Dockets Management (HFA-305), Food and Drug Administration 5630 Fishers Lane, Room 1061
Rockville, MD 20852.