Biomedical Devices:
Information Sources for Standards, Patents, & Regulation
Recommended reading: White, Beth. “Medical Devices and Combination Products.” In: Srodin, Sharon. Using the Pharmaceutical Literature. New York: Taylor & Francis, 2006. Pp. 233-297. On electronic reserve (http://eres.lib.ku.edu/) for ME 633 (Fall 2006) and ME 643 (Spring 2007).
Standards (see White, pp. 255-60)
1. ANSI’s NSSN Search Engine http://www.nssn.org/. “The world’s most comprehensive search engine for standards.”
2. ASTM standards online (linked from http://infogateway.ku.edu/index.cfm?type=dba2z)
Patents (see White, pp. 248-255)
1. Online tutorials for patent searching:
a. http://www.uspto.gov/go/ptdl/step7.htm
b. http://www.lib.utexas.edu/engin/patent-tutorial/index.htm
c. http://www.lib.washington.edu/engineering/ptdl/patents/pt.html)
2. U.S. Patent and Trademark Office. Patent Full-Text and Full-Page Image Databases (http://www.uspto.gov/patft/). Includes U.S. patents issued since 1790 and applications since 2001.
3. esp@cenet. http://www.espacenet.com/ Databases of foreign and international patents.
4. KU resources http://www.lib.ku.edu/EngLib/PatentsAndTrademarks.shtml,
5. White (pp. 251) gives a list of key U.S. patent classes for medical devices.
Regulation (see White, pp. 238-48)
1. FDA (U.S. Food and Drug Administration) Center for Devices and Radiologic Health (CDRH). http://www.fda.gov/cdrh/index.html
a. Guidance Documents http://www.fda.gov/cdrh/guidance.html
b. Device Advice http://www.fda.gov/cdrh/devadvice/
c. CDRH Databases http://www.fda.gov/cdrh/databases.html. Includes:
§ Device Listing (devices in commercial distribution);
§ Premarket Notifications (devices planned for distribution)
§ MAUDE (reports of adverse events involving devices);
2. FDA Office of Combination Products (OCP). http://www.fda.gov/oc/combination/
3. FDA online training materials http://www.fda.gov/ora/training/ORAU/default.htm
4. Regulations.gov http://www.regulations.gov . “On this U.S. Government Web site you can find, view, and comment on regulations and other actions for all Federal agencies.”
Other information sources
1. AdvaMed: Advanced Medical Technology Association http://www.advamed.org/. Represents the manufacturers of “nearly 90 percent of the health care technology purchased annually in the United States.” See “Industry Resources” reports linked from http://www.advamed.org/aboutadvamed.shtml
2. Medical DeviceLink http://www.devicelink.com/ “The online information source for the medical device industry, provides news, information, employment and recruiting services, as well as collaborative opportunities for people who design, manufacture, and market medical devices.”
November 27, 2006
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