Direct Links to important GMP Medical Device Guidelines

Information Document Concerning the Definition of the Term “Medical Device” and IVD

This document is intended to provide harmonized definitions of the terms ‘medical device’ and ‘In Vitro Diagnostic (IVD) medical device’. Bodies and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of Regulatory Authorities to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry.

Medical Devices Post Market Surveillance: Content of Field Safety Notices

This document identifies elements that should and should not be included in safety related notifications issued by the medical device manufacturer or its representative.

Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form

This document provides guidance on: • the criteria to be used for deciding when to exchange information with other national competent authorities and other NCAR participants • the procedures to follow when exchanging information • the forms to use for exchanging the information

Review of Current Requirements on Postmarket Surveillance

This document provides an overview of the current regulatory requirements for Postmarket Surveillance in the 5 founding members of GHTF. As such it is meant to be a status document, representing a brief overview only and does not represent the full scope and nature of the regulations.

Summary of Current Requirements for Where to Send Adverse Event Reports.

Study Group 2 has made an attempt at producing unified guidance regarding who should adverse event reports must be sent to. The main alternatives discussed were: 1. Submission of reports to every regulatory authority of the countries where the device subject of the adverse event report is marketed; 2. Submission of a single report to the regulatory authority of the country in which the adverse event took place, and 3. Submission of a single report to a central global repository (database) of adverse event information.

FDA Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

This guidance document is intended to provide information to industry regarding the documentation that FDA recommends you include in premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software.

FDA Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This guidance provides medical device manufacturers of communicable disease tests, information about performing studies to support modifying the indication for use to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).

FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container

Classification of Cord Blood Processing System and Storage Container

FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule

The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.

FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

This guidance document provides recommendations to manufacturers for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices.

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