Get the free 21 CFR Part 814 Subpart E -- Postapproval Requirements
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CPT04_DE
Version: 1
Approval date: 20220222
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What is 21 cfr part 814?
21 CFR Part 814 pertains to the FDA regulations for premarket approval of medical devices.
Who is required to file 21 cfr part 814?
Manufacturers of medical devices that require premarket approval must file 21 CFR Part 814.
How to fill out 21 cfr part 814?
To fill out 21 CFR Part 814, submit the required application forms, including information on device safety and effectiveness, manufacturing, labeling, and proposed clinical studies.
What is the purpose of 21 cfr part 814?
The purpose of 21 CFR Part 814 is to ensure the safety and effectiveness of new medical devices before they can be marketed.
What information must be reported on 21 cfr part 814?
Information that must be reported includes device description, indications for use, manufacturing processes, and data from clinical studies.
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