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DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health Serviced and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002November 5, 2014 NeuroInvent
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Review the 21 CFR 882.1350 regulation to understand the requirements
02
Identify the medical device that falls under this regulation
03
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Submit the completed documents to the appropriate regulatory authority

Who needs 21 cfr 8821350 regulation?

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Manufacturers of medical devices that fall under the category of 21 CFR 882.1350 regulation
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Regulatory affairs professionals responsible for ensuring compliance with medical device regulations
03
Healthcare facilities and providers who use or prescribe medical devices covered by this regulation
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The 21 CFR 882.1350 regulation pertains to external limb prosthetic components.
Manufacturers of external limb prosthetic components are required to file 21 CFR 882.1350 regulation.
To fill out 21 CFR 882.1350 regulation, manufacturers need to provide detailed information about their external limb prosthetic components.
The purpose of 21 CFR 882.1350 regulation is to ensure the safety and effectiveness of external limb prosthetic components.
Manufacturers must report detailed information about the design, composition, and performance of their external limb prosthetic components on 21 CFR 882.1350 regulation.
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