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RAC Devices 2024/2025 Questions and Answers 100% CorrectRAC Devices 2024/2025 Questions and Answers 100% CorrectRAC Devices 2024/2025 Questions and Answers 100% CorrectRAC Devices 2024/2025 Questions and Answers 100% CorrectRAC Devices 2024/2025 Questions and Answers 100% CorrectWhat did the safe m...

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  • September 29, 2024
  • 18
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • rac devices questions and answers 100 c
  • rac devices questions and answers stuvia
  • what did the safe medical device act do answer

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  • RAC Devices
  • RAC Devices

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RAC Devices 2024/2025 Questions

and Answers 100% Correct


What did the safe medical device act do? - ANSWER-Extended AE reporting

to user facilities, required 510ks with SE, recall authority




General controls - ANSWER-Establishment reg and device listing, GMP,

labels, clearance before marketing




What controls are required by the 3 US classes? - ANSWER-Class 1 - general

controls. Class 2- General and special controls (which include special

labeling, PMS, and performance data) Class 3- general, special, and PMA




What are special controls? - ANSWER-Special labeling, PMS, performance

data




Which devices classes generally have a 510K or PMA? - ANSWER-Class 2 =

510K, Class 3= PMA

,What is substantial equivalence? - ANSWER-Same intended use, technology,

no new questions of safety/effectiveness, as safe as the marketed device




All clinical studies of investigational devices need IDE approval when? -

ANSWER-Before the start of the study




FDA Admin meeting - ANSWER-private or public meeting used for review of

disputes, applications, approvals




FDA Regulatory Communications - ANSWER-release of regulations, guidance

documents




Citizen Petition - ANSWER-Formal request to FDA to refrain from an admin

action




Types of Qsub meetings - ANSWER-Presub, informational, study risk

determination, early collab, submission issue request, PMA Day 100,

Breakthrough designation request




Presub meeting - ANSWER-get feedback on a submission or IDE prior to

submitting. Have 70 days

, Informational meeting - ANSWER-present information or an overview to FDA

without getting feedback. 90 days




What happens if an IDE is deemed not significant risk? - ANSWER-Still needs

IRB approval to have a clinical study, but does not need FDA IDE approval




What types of IDEs require FDA approval? - ANSWER-implants or devices that

present significant risk to patient safety, are life sustaining, measure serious

conditions




Study Risk Determinations - ANSWER-Determine if IDE is significant risk or

exempt




Early Collaboration Meeting - ANSWER-get direction on required testing,

product development. Focus on clinical studies. 30 days




Submission Issue Request - ANSWER-discuss deficiencies. 21 days

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