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Resource : Information & Details

Reporting Problems with Medical Devices

[13484]

Guidance regarding FDA's Safe Medical Device Act of 1990 (SMDA) requirements

Click on any of the Library Categories below to find this and similar resources:
Health : Medical Center Mgt
Handbooks for medical staff and patients, departmental resources

Full text of a medical staff handbook and of a patient handbook in use by the National Institute of Health. Medical department intranet websites. Medical records management.

Health Care Safety : Medical Devices
FDA regulatory guidance for manufacturers of 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.

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