RAC DEVICES 2022 ACTUAL EXAM QUESTIONS
WITH VERIFIED ANSWERS
What did the safe medical device act do?
Extended AE reporting to user facilities, required 510ks with SE, recall authority
General controls
Establishment reg and device listing, GMP, labels, clearance before marketing
What controls are required by the 3 US classes?
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?
Special labeling, PMS, performance data
Which devices classes generally have a 510K or PMA?
Class 2 = 510K, Class 3= PMA
What is substantial equivalence?
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?
Before the start of the study
FDA Admin meeting
private or public meeting used for review of disputes, applications, approvals
FDA Regulatory Communications
release of regulations, guidance documents
Citizen Petition
Formal request to FDA to refrain from an admin action
Types of Qsub meetings
Presub, informational, study risk determination, early collab, submission issue request, PMA
Day 100, Breakthrough designation request
Presub meeting
get feedback on a submission or IDE prior to submitting. Have 70 days
, Informational meeting
present information or an overview to FDA without getting feedback. 90 days
Study Risk Determinations
Determine if IDE is significant risk or exempt
Early Collaboration Meeting
get direction on required testing, product development. Focus on clinical studies. 30 days
Submission Issue Request
discuss deficiencies. 21 days
PMA Day 100
PMA deficiencies. PMA Days 90-100
Breakthrough designation request
Request breakthrough designation for device. 60 days
Acceptance Review
application meets the submission requirements. 14-15 days
Substantiative interaction
FDA working with manufacturer to address questions on the submission or place on hold while
you respond. 60 days for 510k, 90 for PMA
Interactive review
FDA plans a meeting to address issues with submission
MDUFA meeting
Meeting to resolve issues preventing FDA from giving final ok. 100 days for 510k or 20 after the
PMA goal
Design Verification
Confirm outputs meet inputs, requirements are met (confirming internal requirements)
Design Validation
confirming the device meets the intended use / function, external user requirements
Device Indication
The condition that the device is to be used for
Device Intended Use
WITH VERIFIED ANSWERS
What did the safe medical device act do?
Extended AE reporting to user facilities, required 510ks with SE, recall authority
General controls
Establishment reg and device listing, GMP, labels, clearance before marketing
What controls are required by the 3 US classes?
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?
Special labeling, PMS, performance data
Which devices classes generally have a 510K or PMA?
Class 2 = 510K, Class 3= PMA
What is substantial equivalence?
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?
Before the start of the study
FDA Admin meeting
private or public meeting used for review of disputes, applications, approvals
FDA Regulatory Communications
release of regulations, guidance documents
Citizen Petition
Formal request to FDA to refrain from an admin action
Types of Qsub meetings
Presub, informational, study risk determination, early collab, submission issue request, PMA
Day 100, Breakthrough designation request
Presub meeting
get feedback on a submission or IDE prior to submitting. Have 70 days
, Informational meeting
present information or an overview to FDA without getting feedback. 90 days
Study Risk Determinations
Determine if IDE is significant risk or exempt
Early Collaboration Meeting
get direction on required testing, product development. Focus on clinical studies. 30 days
Submission Issue Request
discuss deficiencies. 21 days
PMA Day 100
PMA deficiencies. PMA Days 90-100
Breakthrough designation request
Request breakthrough designation for device. 60 days
Acceptance Review
application meets the submission requirements. 14-15 days
Substantiative interaction
FDA working with manufacturer to address questions on the submission or place on hold while
you respond. 60 days for 510k, 90 for PMA
Interactive review
FDA plans a meeting to address issues with submission
MDUFA meeting
Meeting to resolve issues preventing FDA from giving final ok. 100 days for 510k or 20 after the
PMA goal
Design Verification
Confirm outputs meet inputs, requirements are met (confirming internal requirements)
Design Validation
confirming the device meets the intended use / function, external user requirements
Device Indication
The condition that the device is to be used for
Device Intended Use
