Originally Published MDDI November 2001

A monthly review of new and notable additions to FDA's Web site.

Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance

This document, issued on October 5, 2001, supersedes both Guidance for Electrical Safety, Electromagnetic Compatibility, Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions, issued June 28, 2000, and Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions, issued February 21, 2000. The document describes a means by which indwelling blood gas analyzers may comply with the requirement of special controls for Class II devices. Manufacturers attempting to establish that their device is substantially equivalent to a legally marketed indwelling blood gas analyzer device should demonstrate that the proposed device complies with either the specific recommendations of this guidance or some alternative control that provides equivalent assurances of safety and effectiveness.

Medical Device Reporting—Remedial Action Exemption; Guidance for Industry and FDA

Issued on September 26, 2001, this document supersedes MDR Guidance Document: Remedial Action Exemption E 1996001, dated July 30, 1996. The medical device reporting (MDR) regulation requires device manufacturers to report adverse events for products undergoing remedial action. This document offers guidance on requesting an exemption under 21 CFR 803.19 for reporting certain adverse events that involve device remedial action. FDA intends to grant this exemption to manufacturers when they provide information that indicates additional reports about a device that already has been the subject of a remedial action will not provide any significant new data.

Cancer Drug and Biological Products—Clinical Data in Marketing Applications; Guidance for Industry

This document provides recommendations for sponsors on data collection for cancer clinical trials submitted to FDA to support marketing claims in new drug applications, biologics license applications, or supplemental applications for new indications. Collected data should be sufficient to evaluate the safety and effectiveness of the treatment but need not include other data. This guidance is also intended for private investigators, cooperative cancer groups, contract research organizations, and others designing and conducting studies that later can be used in a marketing application for an anticancer drug or biological product. Because of the complexity of clinical trials and different data that should be included in different situations, the precise data for each trial cannot be specified in a guidance document. This guidance provides general principles for data collection and submission.

Presentation to Central New York Healthcare Central Service Professionals

This September 11, 2001, presentation by Office of Compliance staff describes FDA's current regulatory policy regarding facilities that reprocess single-use devices (SUDs). It also summarizes the regulations that now apply to reprocessors of SUDs and provides information on where to get questions answered.

Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices

This site includes a letter, dated September 25, 2001, to hospital administrators and risk managers. The letter outlines changes in FDA's policy on the reuse of single-use devices (SUDs) that will affect hospital SUD reprocessors. FDA has extended the deadline for active enforcement to August 14, 2002, for the following postmarket requirements: medical device reporting, tracking, corrections and removals, quality system, and labeling.

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections under United States/European Community Mutual Recognition Agreement

FDA is seeking public comment on the proposed collection of information by the agency regarding third-party premarket submission reviews and quality system inspections under the United States/European Community mutual recognition agreement. Written or electronic comments on the collection of information must be submitted to the agency by December 4, 2001.

Updated Information for Clinical Investigators

This site has been recently updated by CBER. Information is provided on participation of females in clinical trials and gender analysis of data in biologic product applications, clinical trials and institutional review boards, good clinical practice in FDA-regulated trials, HHS human research protections, and Center for Drug Evaluation and Research information for clinical investigators.

Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance

This document describes FDA's recommendations for data and information to be provided in 510(k) premarket notifications for radioallergosorbent test (RAST) methods for allergen-specific immunoglobulin E (IgE) test systems. RAST testing measures specific allergen antibodies and may aid in the diagnosis of various pulmonary disorders. The document has been modified to include allergens for which few patient samples are available.

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