FDA Extends Program in Hopes of Helping its Regulators Learn More About the Device Industry

| 01 May 2014 | By Alexander Gaffney, RAC, 

The US Food and Drug Administration (FDA) is once again extending a program intended to help its medical device review staff to better understand the regulatory process from the perspective of the industry it regulates.

The ELP Program

The program, known as the Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort for reforms at the Center for Devices and Radiological Health (CDRH) intended to accommodate criticism from industry.

While criticism from industry varies, particularly depending on the type of product being regulated, a common refrain is that reviewers aren't always realistic about the challenges faced by industry, and that some regulatory staff lack an appreciation of those challenges.

FDA's ELP seems geared toward acknowledging and accepting that criticism. In a September 2011 statement announcing the launch of the program, CDRH Director Jeffery Shuren said the ELP would "[provide] our review staff with opportunities to experience medical device development and use from outside the agency will provide new reviewers with a broader view of the regulatory process for medical devices."

"The program will also help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care," FDA added.

"CDRH is committed to understanding current industry practices, innovative technologies, and regulatory impacts and needs," it said in yet another statement in the Federal Register.

A Strategic Priority for FDA

The program made its way into the agency's January 2012 strategic priorities list, in which it said that the program should be ready to exit the pilot stage and be fully implemented by the end of 2012.

FDA finally launched the program in April 2013, a few months behind schedule, with an appeal to industry to help it to understand its concerns by letting its regulators into their facilities for "formal training visits." Those visits would be strictly educational, and not used to "inspect, assess, judge, or perform a regulatory function," FDA said.

Instead, the visits are intended as "an opportunity to provide the CDRH review staff a better understanding of the products they review," the agency said in the 2013 Register posting. "CDRH is formally requesting participation from companies, academia, and clinical facilities."

At the time, FDA said it had identified 27 areas of interest, ranging from the manufacture of companion diagnostics to the operation of clinical testing in CLIA high-complexity laboratories.

Now, one year later, FDA is re-extending its invitation to industry, but with a shorter list of interests. While some of FDA's interests remain the same, most are new or reflect slightly different scopes of work.

The agency now has 22 areas of interest, down from the previous 27.

FDA's ELP Federal Register Notice