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A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 0 A PMA 1 A Special 510(k), 2 An Individual Device Exemption (IDE), 3 An Annual Report for...
Voorbeeld 2 van de 6 pagina's
In winkelwagenA medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 0 A PMA 1 A Special 510(k), 2 An Individual Device Exemption (IDE), 3 An Annual Report for...
Number of Days for review of PMA - ANSWER-180 days How many routes to a PMA? - ANSWER-3 Routes: 1. 2 3 What makes a PMA unique (vs 510k)? - ANSWER--Must include section on clinical investigations on human subjects -Must include a seperate volume on QS for review by CDRH/OC (office of compl...
Voorbeeld 1 van de 3 pagina's
In winkelwagenNumber of Days for review of PMA - ANSWER-180 days How many routes to a PMA? - ANSWER-3 Routes: 1. 2 3 What makes a PMA unique (vs 510k)? - ANSWER--Must include section on clinical investigations on human subjects -Must include a seperate volume on QS for review by CDRH/OC (office of compl...
Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - ANSWER-C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is ...
Voorbeeld 3 van de 27 pagina's
In winkelwagenWhich division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - ANSWER-C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is ...
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of sys...
Voorbeeld 2 van de 15 pagina's
In winkelwagenWhich of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of sys...
Similar but more detailed than the Essential Requirements - ANSWER-General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - ANSWER-13485:2016 Which entity affixes it's identification number ...
Voorbeeld 2 van de 10 pagina's
In winkelwagenSimilar but more detailed than the Essential Requirements - ANSWER-General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - ANSWER-13485:2016 Which entity affixes it's identification number ...
regulations - ANSWER-legally binding and directly enforceable directives - ANSWER-legally binding but just be transposed into national law each country can decide how they want to implement medical device directive (MDD) - ANSWER-directive 93/42/EEC includes essential requirements for sa...
Voorbeeld 2 van de 7 pagina's
In winkelwagenregulations - ANSWER-legally binding and directly enforceable directives - ANSWER-legally binding but just be transposed into national law each country can decide how they want to implement medical device directive (MDD) - ANSWER-directive 93/42/EEC includes essential requirements for sa...
device - ANSWER-instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article: -recognized by NF-USP -intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease -intended to affect the structur...
Voorbeeld 2 van de 11 pagina's
In winkelwagendevice - ANSWER-instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article: -recognized by NF-USP -intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease -intended to affect the structur...
Who is the European Medicines Agency (EMA) - ANSWER-an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the individual regulatory bodies in Europe. Relevance of EMA...
Voorbeeld 2 van de 5 pagina's
In winkelwagenWho is the European Medicines Agency (EMA) - ANSWER-an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the individual regulatory bodies in Europe. Relevance of EMA...
A 510k is Approved or Cleared? - ANSWER-Cleared A type of 510(k) submission for device modifications neither affecting the intended use nor altering its fundamental scientific technology. FDA processing time is 30 days. - ANSWER-Special 510(k) A type of 510(k) submission that is supported by c...
Voorbeeld 2 van de 12 pagina's
In winkelwagenA 510k is Approved or Cleared? - ANSWER-Cleared A type of 510(k) submission for device modifications neither affecting the intended use nor altering its fundamental scientific technology. FDA processing time is 30 days. - ANSWER-Special 510(k) A type of 510(k) submission that is supported by c...
In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to l...
Voorbeeld 3 van de 18 pagina's
In winkelwagenIn which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to l...
ADR - ANSWER-Adverse Drug Reaction AESGP - ANSWER-Association of the European Self-medication Industry AIFA - ANSWER-Italian Medicines Agency ATMP - ANSWER-Advanced Therapy Medicinal Products CA - ANSWER-Competent Authority CAT - ANSWER-Committee on Advanced Therapies CD-P-PH/ PHO ...
Voorbeeld 2 van de 8 pagina's
In winkelwagenADR - ANSWER-Adverse Drug Reaction AESGP - ANSWER-Association of the European Self-medication Industry AIFA - ANSWER-Italian Medicines Agency ATMP - ANSWER-Advanced Therapy Medicinal Products CA - ANSWER-Competent Authority CAT - ANSWER-Committee on Advanced Therapies CD-P-PH/ PHO ...
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