Direct Links to important GMP Medical Device Guidelines

FDA Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, June 1, 2004

This guidance document describes the types of validation data that FDA recommends be submitted under section 510(o) of the Act. In addition, it provides guidance to industry and FDA staff on how the agency will implement this new section with respect to the submission of validation data in 510(k)s for reprocessed Single Used Devices

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Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1)

The document provides requirements on audit language

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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 we recommend you include in premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software

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Implementatin of risk management principles and activities within a QMS

This document is intended to assist medical device manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples.

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FDA Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff

This guidance has been prepared by the Center for Devices and Radiological Health (CDRH), in coordination with the Center for Biologics Evaluation and Research (CBER), to assist medical device manufacturers in preparing and maintaining the QS information required in premarket submissions1. This guidance replaces “Guidance for Preparation

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FDA Applying Human Factors and Usability Engineering to Medical Devices

FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments.

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FDA HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING

This report presents principles for medical device labeling for use by labeling developers and designers.

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Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices

The objective of the adverse event reporting and subsequent evaluations is to improve protection of the health and safety of patients, users and others by disseminating information which may reduce the likelihood of, or prevent repetition of adverse events, or alleviate consequences of such repetition.

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Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers based on the process approach to quality management system requirements (e.g., ISO 13485:2003 and 21 CFR Part 820).

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Principles of Medical Devices Classification

This guidance document is one of a series that together describe a global regulatory model for medical devices. Its purpose is to assist a manufacturer to allocate its medical device to an appropriate risk class using a set of harmonized principles.

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GMP Conferences by Topics

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