Originally Published MDDI December 2001
NEWS & ANALYSIS
FDA Web Site Update
A monthly review of new and notable additions to FDA's Web site.
Originally issued October 5, 2001, this document supersedes the June 28, 2000, Guidance for Electrical Safety, Electromagnetic Compatibility, Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions, and February 21, 2000, Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions. The document describes a means by which indwelling blood gas analyzers may comply with the requirement of special controls for class II devices. The guidance has been developed as a special control to support a change in classification from class III to class II, and identifies material required for a 510(k) premarket notification application.
Proceedings of the ACR/FDA Workshop on Fluoroscopy
This site provides an out-of-print document that includes presentations from an American College of Radiology (ACR)/FDA workshop, Strategies for Improvement in Performance, Radiation Safety, and Control, which was held October 16–17, 1992.
This memorandum provides written procedures for handling inquiries regarding the need for an investigational device exemptions (IDE) application for research involving medical devices.
This notification emphasizes the importance of keeping radiation doses as low as reasonably achievable during CT procedures, particularly during treatment of pediatric and small adult patients. Such patients may sometimes receive more radiation than needed to obtain diagnostic images. The document emphasizes the importance of adjusting CT scanner parameters appropriately for each individual's weight and size, and for the anatomic region being scanned.
Special Controls Guidance Documents to Reduce Regulatory Burden
CDRH recently developed a special controls guidance document to reduce the regulatory burden associated with obtaining marketing authorization for indwelling blood gas analyzers, and to serve as a possible template for special controls guidance documents for other device types. The site provides a link to indwelling blood gas analyzer documents.
Guidance for FDA Staff: The Leveraging Handbook
Described as a resource for effective collaborations, this guidance to FDA staff represents the agency's current thinking on the topic. Leveraging consists of partnerships, cooperative agreements, or similar collaborative arrangements entered into by FDA and another organization.
Reuse of Single-Use Devices: FDA's Regulatory Requirements for Third-Party and Hospital Reprocessors
This was a presentation by Lily Ng, of FDA's Office of Surveillance and Biometrics at CDRH, at the Regulatory Affairs Professional Society 2001 Annual Conference in Baltimore, MD, in November. The main points of the presentation included development of FDA's policy, principles underlying the policy, a list of regulatory requirements and important dates, premarket submissions received to date, and key issues FDA has encountered in the process.
Annual Comprehensive List of Guidance Documents at FDA
This site provides FDA's annual comprehensive list of all guidance documents currently in use at the agency.
Science at Work in CDRH: A Report on the Role of Science in the Regulatory Process
This is a final report by the CDRH External Review Subcommittee on its assessment of "whether the needed scientific expertise is available currently, whether it is effectively used, and a determination of the scientific expertise needed for the future." The review of the individual FDA Centers by subcommittees of the science board began three years ago with the Center for Biologics Evaluation and Research and more recently included the Center for Food Safety and Nutrition.
NIH Human Embryonic Stem Cell Registry
This site provides an overview of CBER's current regulatory strategy for human tissue. A link is also provided to the National Institutes of Health (NIH) embryonic stem cell registry.
Medical Devices; Exemptions From Premarket Notification; Class II Devices, Final Rule
FDA issued this final rule in response to a petition requesting an exemption for the F-Spoon fluoroscopic compression device. The final rule exempts the device from premarket notification requirements. The manual compression device allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam.
Copyright ©2001 Medical Device & Diagnostic Industry
