Numerous companies from the medical device industry have submitted applications to participate in CDRH's Experiential Learning Program, intended to help train device reviewers.

Marie Thibault

May 11, 2015

2 Min Read
Industry Eager to Help FDA Train Staff

Marie Thibault

CDRH should have no shortage of training opportunities for its medical device reviewers, as several medical device companies have offered to play host to CDRH staff this year. Device makers, ranging from the biggest companies, like Johnson & Johnson and Medtronic, to smaller firms like Actuated Medical Inc. and Penumbra Inc., have volunteered.

In April, CDRH asked for participants in the 2015 Experiential Learning Program (ELP). ELP has been used to train CDRH staff since its pilot year in 2012. Staffers won't be visiting the companies to pass judgment, but instead is "a collaborative effort to enhance communication and facilitate the premarket review process," according to the FDA notice.

As part of the call for participants, CDRH listed numerous topics of interest within the medical device, in vitro diagnostic, and radiological device categories. Included in this list were areas of recent controversy, like "Failure analysis of orthopedic devices," as well as areas of rapid innovation, like "Clinical applications-NGS in practice." 

Medtronic has submitted a proposal to take part with expertise on the topic "Bone grafting materials for dental applications." Abbott Diabetes Care has offered a site visit to its Witney, United Kingdom facility, and Johnson & Johnson's Lifescan Inc. submitted an application on "Manufacturing of glucose test strips and meters."  

Companies weren't the only ones to raise their hand. Academic institutions like the Thayer School of Engineering at Dartmouth College and medical centers like the Hospital for Special Surgery also applied to participate. A visit to the Hospital for Special Surgery would address "Failure analysis of orthopedic devices" and "Imaging analysis of orthopedic devices." The Jacobs Institute, along with partners—The Gates Vascular Institute Clinical Facility and The State University of New York at Buffalo's Toshiba Stroke & Vascular Research Center—wants to work with CDRH staff on "Neurointerventional devices."

While the ELP program is billed as a way to "provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle," there has been recent criticism that FDA's ties to industry are too close for comfort. CDRH director Jeffrey Shuren recently made comments about the struggle to keep staff from leaving for industry positions, saying, "We are the training ground for industry." Surgeon and patient advocate Hooman Noorchashm pointed to Shuren's comments as "a blatant admission to how closely aligned the CDRH is with industry." 

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Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie

[Image courtesy of FRANKY242/FREEDIGITALPHOTOS.NET]

About the Author(s)

Marie Thibault

Marie Thibault is the managing editor for Medical Device and Diagnostic Industry and Qmed. Reach her at [email protected] and on Twitter @MedTechMarie.

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