CDRH Acting Director Jeffrey Shuren Vies For Permanent Spot
Full article reprinted from "The Gray Sheet" - October 12, 2009
Acting device center director Jeffrey Shuren is vying to head the center permanently. He announced his candidacy to agency staff last week, according to Principal Deputy FDA Commissioner Joshua Sharfstein.
Shuren, associate commissioner for policy and planning in FDA Commissioner Margaret Hamburg's office, was appointed interim director after Dan Schultz resigned in August ('The Gray Sheet' Aug. 17, 2009). Shuren began Sept. 2.
Although FDA is reviewing other candidates, if the tone from the commissioner's office is any indication, Shuren has a leg up on the competition.
At an Oct. 14 session of AdvaMed 2009: The MedTech Conference in Washington, D.C., Sharfstein commended Shuren for leading the device center at a critical juncture, and said he has a mandate from Hamburg to move forward aggressively on key priorities.
Last month, Shuren announced his six immediate priorities for the center, including reviewing the 510(k) pre-market notification program, learning how FDA can adapt to changing technology while providing a predictable regulatory pathway, and establishing clear procedures for resolving differences of opinion within the center.
The acting director is developing a set of longer-term, strategic priorities, as well, Sharfstein said.
FDA has commissioned the Institute of Medicine to study and report on the 510(k) program by March 2011, while an internal FDA 510(k) task force researches and implements improvements of its own ('The Gray Sheet' Sept. 28, 2009).
Separately, Shuren has created a task force on science and decision-making to address how FDA can adapt to technological advances. The group has already begun meeting and will seek input from industry and others, Sharfstein said.
Hot Off The Press: SOPs For Internal Disputes
On Oct. 1, Shuren posted a set of standard operating procedures for resolving internal differences of opinion on regulatory decisions. The document fleshes out principles outlined in a 1993 Blue Book memo for Office of Device Evaluation review staff on documenting and resolving disputes.
FDA's general policy is to maintain a work environment where staff members can voice their opinions, even when they differ from prevailing views, without fear of retaliation.
"Managers should create an atmosphere of openness, trust and respect for all individuals' views," the SOPs state.
The document explains in exacting detail the process of raising disputes and elevating them up the chain of command, though efforts should be made to resolve disputes "at the lowest organizational level possible."
It stresses the need to document all relevant opinions and actions in the administrative file, and explains the responsibilities of dispute initiators, managers, appealing parties, office directors, the center director, the CDRH ombudsman and ad hoc dispute resolution committees.
"Differences of opinion happen," Sharfstein said. "When that happens, there has to be an efficient resolution to the issue so that decisions can be made. It has to be a fair process."
"Dr. Hamburg and I very strongly support Dr. Shuren's leadership and his initial agenda for the center," Sharfstein said.
Shuren Aims To Keep 510(k)s Moving
With the 510(k) process under review, some companies worry their 510(k) submissions will face delays. Sharfstein, however, downplayed these concerns.
"Dr. Shuren wants to keep things moving," he said. "He is sending a very clear message that he expects decisions to be made in a timely way."
Shuren, a neurologist and a lawyer, has worked at FDA on and off for the past 10 years. He joined the agency as a medical officer in the Office of Policy in 1998, then left in 2001 to become director of the items and devices division in CMS' Coverage and Analysis group.
Shuren returned to FDA in 2003 as assistant commissioner for policy, and became associate commissioner for policy and planning in 2008.
- Jessica Bylander | 
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