Medical Device Daily Washington Editor

FDA's method for reviewing medical devices has incurred the ire of many of the agency's critics, many of whom feel that some devices that go through the 510(k) program should go through the pre-market approval (PMA) process or are passed through the less-demanding regime too quickly.

Those critics include advocacy group Public Citizen and the National Research Group for Women and Families (both Washington), and Congress responded to these concerns by mandating a study by the Government Accountability Office, which finally published the results of its study last week despite initially promising a publication date of last September.

While the report generated the expected amount of support and criticism from Public Citizen and others, at least one industry group praised the GAO report for its implicit support of the 510(k) program. Backing the position of the agency's external critics, however, are FDA reviewers who have sent two letters recently, one each to Rep. John Dingell (D-Michigan) and the incoming Obama administration, to complain of alleged corruption of the 510(k) program at the Center for Devices and Radiological Health (CDRH) (Medical Device Daily, Jan. 12, 2009), raising the prospect that Congress may take action to slow down the 510(k) pipeline at a time when PMAs are widely thought to be more expensive and take longer.

The GAO report notes that the Safe Medical Devices Act of 1990 (SMDA) required FDA to take a look at the devices that were already on the market in 1976 to establish which of those should be classified as class III high risk devices and which should be categorized as class II or class I devices, which require no more than a 510(k). The reference to 1976 is the year in which the Medical Devices Amendments of 1976 were passed, the first set of device-specific statutes in U.S. law.

SMDA also required that FDA set up a schedule for writing regulations that deal with PMA requirements for any pre-1976 devices that fell into class III or, alternately, reclassify any of those devices into class II. However, FDA officials could not tell the GAO team what sort of time frame had been laid out to deal with these tasks.

In broad outlines, the GAO study, which covered the five-year span between 2003 and 2007, encompassed slightly more than 13,000 submissions for class I and II device devices, 90% of which were cleared, and 342 submissions for class III devices that went through the 510(k) program. Of that number, about 67% (228) were cleared, and of 217 original PMAs and 784 PMA supplements, 78% and 85%, respectively, were approved.

To study how FDA determines whether a 510(k) device application entails new intended uses or involves new technological characteristics, GAO examined files for all class III 510(k) devices and employed a stratified random sampling technique to pull files for class II devices, which gave the GAO team 459 files to work with.

Using data "primarily from the FDA reviewer's memo, which outlined the decisions FDA made to reach its determination," GAO concluded that of the 459 applications reviewed, 24 involved class III devices, 20 of which "could still be cleared through the 510(k) process." The other four had been reclassified into the PMA basket.

Based on that outcome, GAO extrapolated that of all 510(k)s reviewed by FDA between 2003 and 2007 (class II and class III, those that passed and those that did not), "about 1% had a new intended use and about 15% had new technological characteristics." Of the 510(k) applications that failed the substantial equivalence test during this period, which numbered 248, "more than half the devices had a new intended use or novel technological characteristics."

The report notes that GAO recommends that FDA issue regulations to "reclassify each device type into class I or class II, or requiring it to remain in class III, and for those device types remaining in class III, require approval for marketing through the PMA process." According to GAO, managers at the Department of Health and Human Services agreed to the recommendations, but declined to specify a time-frame for completion.

In a Jan. 15 statement, Janet Trunzo, executive vice president for technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed; Washington), said the association "is pleased the GAO report clearly supports the effectiveness of FDA's 510(k) premarket review process," and she added that the GAO report "demonstrates that medical devices reviewed by FDA under the 510(k) process are subject to the appropriate level of regulation to ensure their safety and effectiveness."

Sidney Wolfe, executive director of Public Citizen, wrote in a Jan. 15 statement that the report "highlighting the dismal job the Food and Drug Administration does in regulating medical devices shows that the approval process at the FDA is irredeemably broken." Wolfe also bemoaned that "many high-risk devices are going through a less-stringent review process before being used in patients."

FDA opens offices in India

FDA's overseas reach is expanding with the Jan. 15 announcement that the agency has opened two new offices in India, one in New Delhi and the other in Mumbai, the site of a recent terrorist attack that drove India into a confrontation with its neighbor, Pakistan.

According to the statement, published by the Department of Health and Human Services, FDA "will post 10 experienced officials in India to work closely with industries that ship food and medical products to the United States" in the pursuit of better safety and quality without impeding trade. The staff will include an office director along with "four inspectors and five senior technical experts who will cover food, medical devices and medicines."

The HHS statement notes that India is "the fourth-largest exporter by volume of drugs and biologics, especially generic pharmaceuticals, to the United States" and is also "a significant exporter of food products."