Biomedical Engineering Research: Industry / Product Info
FDA Medical Device Regulations & Resources
- Center for Devices and Radiological Health (CDRH)
Branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.
- Device Advice: Comprehensive Regulatory Assistance Device Advice, is the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) web page for comprehensive regulatory information, explains the many aspects of medical device laws, regulations, guidances, and policies.
- Device Labeling
- Product Classification for Medical Devices
FDA database that lists all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information.
- FDA Medical Device Databases
- How to Study and Market Your Device Explains the steps one must take prior to marketing a medical device in the United States.
- Quality System Regulation (QS) / Good Manufacturing Practices (GMP) Includes requirements related to designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.
Product Information / Suppliers
Directory of suppliers to the medical device industry.
AbleData provides information on over 40,000 assistive and rehabilitation products and equipment available from domestic and international sources. For each product, they provide a description of the product's functions and features, price information (when available), and contact information for the product's manufacturer and/or distributors.
Business Information / Marketing Reports / Directories
Citation Management Software
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