Oberons rac drugs - Study guides, Class notes & Summaries

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...

Oberon-s RAC Drugs Exam Questions and Answers

Oberon's RAC Drugs Questions and Answers TEA process ANSWER 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) ANSWER ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt ANSWER no effectiveness data required misbranded device ANSWER not cleared through 510k process (but needs one) adultered device ANSWER does not have PMA but needs one design input for device ANSWER requirements that must be met I...

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