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US Medical Device Regulations

This class was created by Brainscape user Suzanne Wertz. Visit their profile to learn more about the creator.

By: Suzanne Wertz
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Decks in this class (11)

US Glossary
21st century cures act cca,
30 day hold,
120 day safety report
528  cards
US History (Ch. 1)
What are the three branches of th...,
What branch of the us government ...,
What branch of the us government ...
85  cards
Overview of US Regulatory Pathways (Ch. 2)
What is the cfr,
What is the usc,
How often is the cfr updated
45  cards
Clinical Trials (Ch. 3)
What is the purpose of clinical t...,
What does gcp stand for,
What is the definition of gcp
87  cards
ISO 14155:2020 Terms and Definitions
Adverse device effect ade,
Adverse event ae,
Audit
56  cards
ICH GCP E6(R2) Definitions
Adverse drug reaction adr,
Adverse event ae,
Applicable regulatory requirements
62  cards
cGMP and Quality System Design (Ch. 4)
What does cgmp stand for,
What does qsr stand for,
What is the cgmp qsr regulation f...
66  cards
Medical Device Submissions (Ch. 5)
What is the significance of the f...,
What is the significance of the m...,
What does cdrh stand for
80  cards
Medical Device Compliance and Post-marketing Activities (Ch. 6)
What is 21 cfr part 807,
How often do establishment regist...,
True false initial annual and upd...
52  cards
In Vitro Diagnostics Submissions and Compliance (Ch. 7)
What fda centers have oversight o...,
What is the role of cdrh for ivd ...,
What is the role of cber for ivd ...
51  cards
Advertising, Promotion, and Labeling for Medical Devices and IVDs (Ch. 8)
What is the definition of a label,
What is the definition of labeling,
What is the regulation for genera...
20  cards

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US Medical Device Regulations

  • Class purpose General learning

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