No Comment From FDA on Report Concerning Medical Device Safety

I started working at FDA on January 18, 1988 answering phones in the Consumer Affairs (now Public Affairs) Office at the San Francisco District Office. Each day I would get an earful on everything from aluminum frying pans to the latest diet craze. FDA is used to people complaining about their activities. They are very good at responding, even if they have little new to say.

However, this week the Project on Government Oversight (POGO), a well known government watchdog organization, issued a report entitled, “The FDA’s Deadly Gamble with the Safety of Medical Devices” (18 February 2009). The report details the concerns of FDA scientists, professional organizations, and consumer advocates about FDA’s decision to stop requiring important medical device safety studies to be conducted under the Good Laboratory Practice (GLP) regulations (21 CFR Part 58). So far there has been no response on the FDA website.

The GLP regulations do not cover practices at most laboratories. For example, if you go to the hospital to have your cholesterol checked this would not be part of the GLP oversight. The GLPs are for safety studies that take place on drugs, biologics, and medical devices before clinical trials take place in human subjects. They are a critical part of the process that FDA uses in evaluating new health products.

One possible reason that response to the POGO report has been delayed is that it is very well researched with clear documentation of the problems. The POGO report is listed on the Blogroll on the right. Part of the documentation is “Appendix A,” a memorandum from scientists in the Division of Bioresearch Monitoring in the Office of Compliance in FDA’s Center for Devices and Radiological Health. These public health professionals make a strong case for compliance with the GLP regulations. Although there is the necessary technical writing, it is a rare glimpse into how FDA regulations are enforced, the steps FDA scientists are taking to protect public health, and is worth reading. The Blog reprints the memorandum, Appendix A, in whole in Interesting Articles on the right, “POGO Report…”

You can read additional posts on FDA Commentaries here:


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