An Overview of the Regulatory Aspects of Medical Devices From the Viewpoint of Research and Device Manufacturing. (November 1993)

• Record Type: Journal Article
• Authors: Patrick, Jane
• Is Part Of: Regional anesthesia. Volume 18(1993)Supplement 6
• Page Start: 424
• Page End: 427
• Publication Date: 1993-11
• Subjects: [Premarket notification -- Premarket Approval -- Food and Drug Administration -- continuous spinal catheter -- medical device testing requirements.]; Conduction anesthesia -- Periodicals; Pain medicine -- Periodicals; 617.964
• DOI: 10.1136/rapm-00115550-199318061-00008
• Languages: English
• ISSNs: 0146-521X

Abstract

Abstract : Purpose: To review the Food and Drug Administration's regulatory requirements for bringing a new or substantially changed medical device to market in the United States, noting the history and current requirements for the continuous spinal catheter. Method: The relevant laws and guidelines for classifying, testing, and submitting a device to Food and Drug Administration approval are reviewed. Results: The Food and Drug Administration categorizes medical devices into three classes, based on potential risk for illness or injury presented by a malfunction or failure. Class III devices are the most critical ones, and require a Premarket Approval that includes clinical trials before market introduction. Classes I and II usually require a 510(k), or premarket notification, which usually does not need any clinical data. Testing requirements include biocompatibility testing; physical, functional, and packaging testing; and sterility testing. The continuous spinal catheter (25-32 gauge) was marketed under a 510(k) claiming substantial equivalence to the Bizzarri-Giuffrida 24-gauge catheter, which was a pre-Amendment device. After incidences of cauda equina syndrome were reported with use of the continuous spinal technique, the Food and Drug Administration reclassified the small-gauge catheters as Class III devices, which require a Premarket Approval before being marketed.