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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