Drehereien

Kategorie: Industrie: Drehereien:


http://www.drehereien.com/
Eintrag vom: 21.06.2013.


Life-supporting or life-sustaining device means a device that is essential to or that yields information that is essential to the restoration or continuation of a bodily function important to the continuation of human life.
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860/subpart-A/section-860.3
 ECFR


In 1976 the Medical Device Amendments were added to the United States (U.S.) Federal Food Drug and Cosmetic Act (FD&C Act) of 1938 establishing the current risk-based classification system for all medical devices the FDA regulates.
https://www.emergobyul.com/sites/default/files/2023-06/US-FDA-Device-Classification-white-paper.pdf
 EMERGOBYUL


The United States Food and Drug Administration regulates medical devices. See what is regulated the classification systems and outline of the approval process.
https://www.regdesk.co/regulations-library/united-states/
 REGDESK


Learn the essentials of the US FDA medical device definition and its classifications.
https://www.bioaccessla.com/blog/understanding-the-us-fda-medical-device-definition-and-classifications
 BIOACCESSLA


Medical Device's definition according to European Union Medical Device Regulation (EU MDR) United States Food and Drug Administration (FDA) and WHO.
https://www.scilife.io/glossary/medical-device
 SCILIFE


Facilitate medical device innovation by advancing regulatory science providing industry with predictable consistent transparent and efficient regulatory pathways and assuring consumer confidence in devices marketed in the U.S.
https://www.standardsalliance-mdrc.org/wp-content/uploads/2023/12/Overview-of-FDA-Regulation-of-Medical-Devices-FDA-101_Michelle-Noonan_USFDA-CDRH_6nov23.pdf
 STANDARDSALLIANCE-MDRC


Learn more about the eCFR its status and the editorial process.
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H
 ECFR



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