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US Medical Document Regulations
The following documents are provided as a service to
the medical device community. Although we do our best to ensure that these
documents are the latest versions, changes may occur without notice. If
you would like to suggest a document for inclusion or we have included
an outdated version, please let
us know. All documents were published by the US Food and Drug Administration
and are in PDF format unless otherwise noted.
Bar
Code Label Requirements - Question and Answer
Container
and Closure System Integrity Testing in Lieu of Sterility Testing
Content
of Premarket Submissions for Software Contained in Medical Devices
Current
Good Manufacturing Practice for Combination Products
Expedited
Review for Medical Device Submissions
FDA Export Certificates
FDA User Fees: 2008-2012
Food,
Drug and Cosmetic Act - Medical Devices
General
Principles of Software Validation
Human
Factors in Medical Device Design
ICH Q9
Quality Risk Management
In
Vitro Diagnostic (IVD) Device Studies FAQ
Labeling
for Medical Devices
Post
Market Surveillance Guidance
Premarket
Assessment of Pediatric Medical Devices
Premarketing
Risk Assessment
Providing
Regulatory Submissions in Electronic Format - Content of Labeling
Quality
Systems Regulations (QSR)
Use
of Symbols on Labels of IVDs for Professional Use
Validation
Data for Reprocessed Single-Use Devices
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