Correspondence between POGO and the Center for Devices and Radiological Health (CDRH) of the FDA

POGO is examining a long-standing regulation, the Good Laboratory Practice (GLP) regulation, 21 CFR Part 58, which is meant to ensure the safety of medical devices. Specifically, POGO is examining the apparent failure of a large subdivision of the FDA – the Center for Devices and Radiological Health (CDRH) – to enforce the regulation. POGO is preparing a report on the findings of this examination.

On April 30, 2008, POGO wrote CDRH Director Daniel Schultz asking a series of questions about the apparent decision not to enforce the GLP regulation. On May 13, 2008 POGO sent him a follow-up letter, and on May 27, 2008 POGO received a reply from the Associate Director of a unit within CDRH.