QS & the FDA: Guidance Documents
Manufacturer Guidance
The FDA and the Global Harmonization Task Force (GHTF) provide several guidance documents to aid manufacturers in their compliance with the above regulations. Links to some of these documents are provided below. More documents can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfGGP/Search.cfm.
General
- Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers, December 2008
- Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements, GHTF Guidance SG4.(99)28, June 1999
- Recognition and Use of Consensus Standards, FDA OSEL, June 2001
- Essential Principles of Safety and Performance of Medical Devices, GHTF SG1/N41R9, May 2005
- Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy, GHTF Guidance SG4/N30R20, June 2006
- Medical Device Tracking: Guidance for Industry and FDA Staff, FDS/CDRH office of Compliance, November 2007
MDR
Labeling
Inspections
- Investigational Operations Manual, FDA ORA
- Compliance Program Guidance Manual for Inspection of Medical Device Manufacturers, FDA Compliance Program 7382.845, June 2006
- Guide to Inspections of Quality Systems (QSIT), FDA ORA, August 1999.
A formatted and bound version is available for purchase from AAMI - link here.
510(k) Submissions
- Quality System Information for Certain Premarket Application Reviews, FDA CDRH, February 2003
- The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, FDA CDRH, March 1998
- Deciding When to Submit a 510(k) for a Change to an Existing Device, FDA CDRH, January 1997
Risk Management
- Hospital Bed System Dimensional Guidance to Reduce Entrapment, FDA CDRH, March 2006
- Implementation of risk management principles and activities within a Quality Management System, GHTF Guidance SG3/N15R8, May 2005
- Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, FDA CDRH, July 2000
Software Validation
- Computerized Systems Used in Clinical Investigations, FDA OC, May 2007
- Content of Premarket Submissions for Software Contained in Medical Devices, FDA CDRH/CBER, May 2005
- Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, FDA CDRH/ODE, January 2005
- Part 11, Electronic Records; Electronic Signatures – Scope and Application, FDA, August 2003
- General Principles of Software Validation; Final Guidance for Industry and Staff, FDA CDRH/CBER, January 2002
- Off-The-Shelf Software Use in Medical Devices, FDA CDRH, September 1999
- Glossary of Computerized System and Software Development Terminology, FDA ORA, August 1995
Design Controls
- Human Factors Implications of the New GMP Rule, CDRH, April 1998
- Design Control Guidance for Medical Device Manufacturers, FDA CDRH, March 1997
- Do It by Design: An Introduction to Human Factors in Medical Devices, CDRH, December 1996