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DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE LABORATORY PATIENT REPORT AUTO FAXING/PRINTING CERTIFICATION / VALIDATION LOG Since mailed Pathology reports will be discontinued September 30, 2023,
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What is cures act fact sheet?
The Cures Act fact sheet provides information about the 21st Century Cures Act, a law designed to help accelerate medical product development and bring new innovations and advances to patients faster.
Who is required to file cures act fact sheet?
Manufacturers and importers of medical products regulated by the FDA are required to file the Cures Act fact sheet.
How to fill out cures act fact sheet?
The Cures Act fact sheet can be filled out electronically on the FDA's website or submitted through the FDA's electronic submission portal.
What is the purpose of cures act fact sheet?
The purpose of the Cures Act fact sheet is to provide transparency and accountability in the medical product industry, as well as to facilitate the reporting of information related to medical product development and safety.
What information must be reported on cures act fact sheet?
Information such as product details, manufacturing processes, safety data, adverse events, and product performance must be reported on the Cures Act fact sheet.
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