SAN JOSE, Calif. – The U.S. Food and Drug Administration has become tougher but more predictable in how it handles medical products seeking approval under its 510(k) process, said a consultant at the DesignMed conference, part of the Design West event here.
The observations come at a time when the FDA process has been undergoing internal reforms and intense scrutiny. The 510(k) is the fastest and most widely employed regulatory path for medical devices, used for about 4,000 products a year classified as moderate risk.
Since June, the FDA has been rejecting a greater number of 510(k) applications. However it is also becoming more consistent about its criteria and engaging applicants more directly, said the consultant.
Under the 510(k), applicants ask FDA examiners to approve a new device because it is “substantially equivalent” to an existing device, called a predicate. “Our experience is the FDA is getting pickier and picker on what they will accept as a predicate device,” said Chris Henza, a regulatory affairs specialist at Regulatory Compliance Associates, Inc. (Kenosha, Wis.), speaking in a DesignMed session.
In addition, the FDA has tightened up some parameters. In the past, applicants frequently pointed to as many as 30 predicate devices. But going forward, the FDA’s guidance suggests it will only consider one main and one secondary predicate device, she said.
However examiners also have been “consistently asking all the same questions,” said Henza who submitted a diverse set of five 510(k) applications in the last nine months.
“It’s definitely getting more predictable, they are actually doing what they say they are doing,” she said. “In the past there were more inconsistencies,” she added.
Late last year, the FDA issued new guidance on the 510(k) process as part of ongoing reforms it initiated in January 2011. The guidance included a flow chart to explain the process, something the agency seems to be following, Henza said.
The latest guidance statement was more detailed—nearly three times the length of past FDA guidelines for 510(k) applications—and the agency seems to be adhering closely to it. “They expect you to go through every point of your device and refer to all the guidance questions” in an application, she said.
In the past, examiners typically informed applicants of rejections by letter and fax. Since June, “they have actually called and asked questions” of applicants, she said.
“If you can explain what you are trying to do, they will put [the application] through,” she added.
The changes come at a time when the FDA has been under intense scrutiny. Congress mandated an external review of the 510(k) process, a job handled by a group of experts from the Institute of Medicine. The IoM’s report, issued last July, called for scrapping the 510(k) process completely, a conclusion the FDA and industry both were quick to reject.
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