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GLOSSARY of terms
regulatory & clinical terminology distilled
Whether you are an emerging medical device or drug company, we're here to help.
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21 CFR 812
21 CFR 820
21 CFR Part 11
510k
Abbreviated New Drug Application (ANDA)
Code of Federal Regulations (CFR)
Cooperative Research
De Novo
European Union’s Medical Device Regulation (EUMDR)
Exploratory IND
FDA Form 483
Form FDA 1571
Form FDA 1572
General Control
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Human Factors
Humanitarian Device Exemption (HDE)
Humanitarian Use Device (HUD)
ISO 13485
In Vitro Diagnostic (IVD)
Informed Consent Form (ICF)
Institutional Review Boards (IRB)
International Conference on Harmonization (ICH)
Investigational Device Exemption (IDE)
Investigational New Drug Application (IND)
Investigator
Medical Device
Medical Device Directive
New Drug Application (NDA)
Predicate Device
Premarket Approval (PMA)
Quality Management System
Serious Adverse Event (SAE)
Software as a Medical Device (SaMD)
Special Control
Sunshine Act
Warning Letter
21 CFR 812
21 CFR 820
21 CFR Part 11
510k
ISO 13485
Abbreviated New Drug Application (ANDA)
Code of Federal Regulations (CFR)
Cooperative Research
De Novo
European Union’s Medical Device Regulation (EUMDR)
Exploratory IND
FDA Form 483
Form FDA 1571
Form FDA 1572
General Control
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Human Factors
Humanitarian Device Exemption (HDE)
Humanitarian Use Device (HUD)
In Vitro Diagnostic (IVD)
Informed Consent Form (ICF)
Institutional Review Boards (IRB)
International Conference on Harmonization (ICH)
Investigational Device Exemption (IDE)
Investigational New Drug Application (IND)
Investigator
Medical Device
Medical Device Directive
New Drug Application (NDA)
Predicate Device
Premarket Approval (PMA)
Quality Management System
Serious Adverse Event (SAE)
Software as a Medical Device (SaMD)
Special Control
Sunshine Act
Warning Letter
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