CDRH director Burlington to step down

Article

After 18 years at the Food and Drug Administration, Dr. Bruce Burlington will leave the agency in March, FDA Commissioner Dr. Jane Henney announced last month. Burlington is leaving his position at the FDA to head regulatory affairs at Wyeth-Ayerst

After 18 years at the Food and Drug Administration, Dr. Bruce Burlington will leave the agency in March, FDA Commissioner Dr. Jane Henney announced last month. Burlington is leaving his position at the FDA to head regulatory affairs at Wyeth-Ayerst Pharmaceuticals in Philadelphia.

After joining the FDA in 1981, Burlington held several posts before becoming director of the Center for Devices and Radiological Health (CDRH) in 1993 (SCAN 5/19/93). He is credited with streamlining the agency's 510(k) review process, eliminating its product review backlog, and dramatically cutting review times.

In December, the CDRH released product review data that indicate how far the center has come since the dark days of the mid-1990s. In 1998, the CDRH had the shortest review time for pre-market approval (PMA) applications in a decade: From October 1997 to September 1998, the agency cleared 33% of PMAs in less than 180 days, and 63% in less than a year. The average total review time for 510(k) applications for the period was 114 days, an improvement over 130 days in fiscal year 1997 and 145 days in 1996. Almost 60% of 510(k) applications received by the agency during fiscal year 1998 were cleared within 90 days.

Recent Videos
New Mammography Studies Assess Image-Based AI Risk Models and Breast Arterial Calcification Detection
Can Deep Learning Provide a CT-Less Alternative for Attenuation Compensation with SPECT MPI?
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Current and Emerging Legislative Priorities for Radiology in 2025
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 2
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 1
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 1
Related Content
© 2025 MJH Life Sciences

All rights reserved.