The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
Origin/Publisher:
FDA
Document Type:
Guidance
Content:
This guidance serves to assist manufacturers in their development, and to assist Center reviewers in their review and evaluation of medical device patient labeling to help make it understandable.
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