Download Medical Device de Novo Classification Process PDF Free - Full Version
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About Medical Device de Novo Classification Process
This document establishes new regulations for the medical device De Novo classification process. The De Novo process provides a pathway for new devices to obtain marketing authorization as class I or II devices instead of being designated as class III devices requiring premarket approval. The final rule outlines procedures and criteria for submitting and reviewing De Novo requests, as well as classifying devices. It is intended to provide an efficient process to ensure appropriate device classification consistent with public health protections.
Detailed Information
| Author: | ['qfbfabyhola'] |
|---|---|
| Publication Year: | 2021 |
| Pages: | 84 |
| Language: | English |
| Format: | |
| Price: | FREE |
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