Direct Links to important GMP Medical Device Guidelines

FDA PART 820—QUALITY SYSTEM REGULATION

cGMP rules for Medical Devices (21 CFR 820)

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FDA Guide to Bioresearch Monitoring Inspections of in vitro Diagnostic Devices

The purpose of this guide is do describe that bioresearch monitoring inspections is to ensure that data and information contained in premarket applications are scientifically valid and accurate.

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FDA Alternative to Certain Prescription Device Labeling Requirements

The guidance for industry addressess manufacturers, repackers, relabelers, and distributors of prescription devices which may wish to use the same symbol statement “Rx only” as an alternative to the prescription labeling requirements, under sec.801.109.

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FDA Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems

This guide provides FDA investigators with information regarding electromagnetic compatibility (EMC) and how it is likely to be addressed in a medical device firm's Quality System/Good Manufacturing Practices

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FDA Inspections of Medical Device Manufacturers

This guide was prepared to address concerns about consistency and uniformity of inspection between the domestic and foreign inspection programs. Consistency and uniformity of inspection and enforcement represent high priority goals for the Office of Regulatory Affairs (ORA). This guide sets forth clear instructions regarding the approach to the foreign inspection.

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FDA Guide to Inspections of Infectious Disease Marker Testing Facilities

This guide provides the current interpretation of certain regulations and guidelines regarding Infection Disease Marker Testing Facilities

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Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable1 medical devices.

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Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations

This document defines the content of the Regulatory Assessment Program. The Assessment Program defines how Regulatory Authorities will recognize, monitor, and re-recognize Auditing Organization under the framework of the IMDRF MDSAP.

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Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.

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Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

This Directive shall apply to active implantable medical devices.

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GMP Conferences by Topics

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