Medical.

Legal Publisher, December, 2005

FDAnews (Washington, D.C.) has released "Roadmap to FDA Laws and Regulations: Medical Devices and Radiation Emitting Products," a management report that includes definitions and classifications of medical devices, relevant guidance for FDA and the industry, specifics on medical device tracking, specifics on reporting requirements, and legal precedents in the areas of the Doctrine of Preemption and 'fraud on the FDA.' Available only as a PDF file, it also includes information on risk assessment, advertising, labeling requirements, agency enforcement actions, criminal enforcement actions for not reporting malfunctions, and enforcement of electronic product radiation control.

The report costs $249.