Permanent Director Appointed at FDA’s CDRH

From the Wire: Dr Jeffrey Shuren has been appointed permanent Director of FDA’s Center for Devices and Radiological Health (CDRH). He previously served as Acting Center Director after the resignation of Dan Schulz in August 2009. FDA Commissioner Margaret Hamburg appointed Shuren to the job on a permanent basis on 20 January 2010, reports Reuters.

The report goes on to say that, Hamburg had said she was cleaning up problems in the division before Shuren took the acting post. Issues that have drawn scrutiny in recent years include recalls of products from top manufacturers such as Medtronic Inc and Boston Scientific Corp. FDA scientists also complained about pressure from top managers, and congressional investigators found shortcomings in the process for approving some riskier devices.

The Institute of Medicine is studying a fast-track approval process for certain devices, and Hamburg has ordered an internal review.

Dr Shuren has held various positions at FDA since 2009, including Acting Deputy Commissioner for Policy, Planning and Budget. In a previous job for Medicare and Medicaid Services, he oversaw the development of Medicare national coverage decisions for drugs, biologics and nonimplantable devices.

CDRH has set out four priority areas for FY 2010.These include strengthening product reviews and increasing transparency about decision-making, according to documents posted on FDA’s website.

It says it will enhance and integrate premarket, postmarket and compliance information and functions and will improve the quality and consistency of its science-based decision making by strengthening premarket review and aligning its use of scientific resources across the Center.

To proactively facilitate innovation and address unmet public health needs, it will foster the development of medical devices to respond to unmet public health needs by collaborating with federal government partners and external constituencies to reduce identified barriers.

Tags: FDA CDRH, Jeffrey Shuren