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GCat: Safety
MCat: Safety
Cat: Medical Devices

US Food and Drug Administration guidance on the CDRH requirements related to medical device manufacturing safety requirements - recalls, reporting, quality, use errors, etc. Various inspection guides used by FDA field staff for audits. Mammography facility regulatory guidance.

47 Resources
AdvaMed - Advanced Medical Technology Association [26980] ?

Represent manufacturers of medical devices

Association for the Advancement of Medical Instrumentation [16457] ?

Create medical instrumentation standards

Can Inspection Time Be Reduced?: Developing a HACCP Plan [25397] ?

The experience of a medical device company

Design Control Practices for Medical Devices [26572] ?

A series of articles related to the subject

Developing a Comprehensive Quality System [26573] ?

Articles on quality assurance and control for medical device safety

Developing a Comprehensive Quality System for Medical Devices [25396] ?

An effective quality system must integrate risk management, customer satisfaction, and continuous improvement

ECRI Medical Device Problem Reporting [24285] ?

How to report a problem to ECRI and to the FDA

Updated Electronic Product Radiation Control [22446] ?

US FDA requirements for ionizing and non-ionizing products, including medical products

Exploring Postdevelopment Risk Management [26571] ?

Applying HACCP principles can minimize the introduction of risk factors in medical device safety

Exporting Medical Devices [16495] ?

Procedures options for U.S. firms to export both approved and unapproved medical devices

Factoring the Law into Medical Device Design [25398] ?

Certain steps during the design process can reduce a manufacturer's risk

FDA Databases [25401] ?

Databases of interest to medical device manufacturers

FDA Electromagnetic Compatibility Program [24730] ?

FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities

FDA Guidance Documents for Medical Device Manufacturers [16472] ?

For manufacturers of medical devices

FDA Inspection Guide of Medical Device Manufacturers [16465] ?

Guidance to FDA inspectors on medical device Quality System/GMP Regulation (QS/GMP) audits

FDA Inspection Guide to Bioresearch Monitoring of In Vitro Diagnostic Devices [16463] ?

Guidance to the FDA field staff conducting bioresearch monitoring inspections for IVD devices

FDA Inspection Guide: Mammography Quality Standards Act Auditor's Guide [16464] ?

This guidance document represents the FDA's current thinking on MQSA audits

FDA Inspection Handbook: Guide to Inspections of Quality Systems (QSIT) [16461] ?

Guidance to the FDA field staff to assess a medical device manufacturer's compliance

FDA Inspection of Electromagnetic Compatibility Aspects of Medical Device Quality [16462] ?

Guidance to FDA investigators regarding EMC & how it's addressed in a manufacturer's QS/QMP

FDA Inspector's Technical Guides [16466] ?

Provide FDA personnel with technical background in a specific piece of equipment

FDA Labeling Requirements of Medical Devices [16492] ?

Guidance on FDA medical device labeling requirements

FDA Medical Device Databases [16488] ?

501(k)s, PMAs, GGP, MDR, MAUDE, NHRIC and other FDA medical device databases

FDA Medical Device Guidance Documents [16489] ?

Good guidance practice documents

FDA Medical Device Reporting - Event Problem Codes [16482] ?

Mechanism for FDA to identify and monitor significant adverse events involving medical devices

FDA's Human Factors Standard [26575] ?

HE 75 is the result of the effort to create best practices guidance in medical device human factors engineering

HACCP: Resolving Medical Product Safety and Liability Nightmares [25395] ?

The benefits of implementing HACCP into a product development and manufacturing process are well worth the effort

HE74:2001 Human Factors Design Process for Medical Devices [24260] ?

Provides an overview of the standard - does not provide the text of the standard

Human Factors & Medical Devices [16454] ?

Information for Manufacturers and Distributors on medical device labeling, etc.

Human Factors in Medical Devices Primer [16468] ?

Primer to improve the safety of medical devices by reducing likelihood of user error

Human Factors in Medical Devices: Design, Regulation, and Patient Safety [1283] ?

Incorporating Human Factors Engineering into Risk Management

Human Factors Program - FDA Medical Devices [16456] ?

Human factors guidance from the FDA

Medical Device Safety Reports [14751] ?

A repository of medical device incident and hazard information

Medical Device Standards [25399] ?

A series of articles on complying with standards that affect the medical device industry

Medical Device Testing and Inspection [26574] ?

A series of articles related to the subject

Medical Device User Fee and Modernization Act (MDUFMA) of 2002 [22453] ?

Federal Register notices, fees, forms, guidance documents, reports

Medical Imaging - FDA Requirements [16473] ?

Laws, regulations, industr guidance and more

MQSA FDA Inspection Guide: Mammography Facilities [16474] ?

Implementation of the Mammography Quality Standards Act of 1992 (MQSA) - inspections

MQSA Regulatory Guidance Documents [16477] ?

FDA compliance guidance for mammography facilities

Postmarket Medical Device Requirements [16483] ?

Manufacturers must follow certain requirements and regulations once devices are on the market

Quality System (QS) Regulation/Medical Device Good Manufacturing Practices [16467] ?

FDA Good Manufacturing Practice (GMP) Requirements Quality System (QS) Regulation Information

Quality System (QS) Regulation/Medical Device Good Manufacturing Practices [16470] ?

The Good Manufacturing Practice (GMP) (also known as the Quality System Regulation) - FDA requirements

Radiation Emitting Devices FDA Labeling Requirements [16479] ?

Guidance on FDA requirements

Recalls of Medical Devices [16490] ?

FDA database of medical device recalls

Risk Management for Medical Devices [25400] ?

A series of articles on the subject

The Use & Misuse of FMEA in Risk analysis [26570] ?

Failure modes and effects analysis can be a helpful tool in risk management for medical devices but has traps

Tracking of Medical Devices - Unique Device Identification [16491] ?

Requirements of the Food and Drug Administration Amendments Act of 2007 for unique device identifiers

Wireless Medical Telemetry - Electromagnetic Interference Concerns and Solutions [24732] ?

FDA Guidance for Industry - Wireless Medical Telemetry Risks and Recommendations


Related Categories & Information

- rmLibrary : Related Categories (6)

Legal / Health Law
Case developments, articles, resources related to medical law

Medicine / Radiation
Resources related to nuclear medicine

Risk Mgt / Medical Liability
Medical malpractice, risk management in medicine, insurance, etc.

Safety / Needlesticks
Needlestick injury prevention, legislation, safety devices

Safety / Patient Safety
Medical errors, medication errors, patient safety guidance

USA Government / FDA
Departments and agencies of US Food and Drug Administration


- Cross References to other LAD Libraries (9)


- Cross References to LAD Directories (6)


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