RAC DEVICE GENERAL PREP FINAL
PAPER 2026 QUESTIONS WITH FULL
ANSWERS VERIFIED
⩥ 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
⩥ 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
⩥ PMA Day 100. Answer: PMA deficiencies. PMA Days 90-100
⩥ Breakthrough designation request. Answer: Request breakthrough
designation for device. 60 days
⩥ Acceptance Review. Answer: application meets the submission
requirements. 14-15 days
⩥ Substantiative interaction. Answer: 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. Answer: FDA plans a meeting to address issues
with submission
⩥ MDUFA meeting. Answer: Meeting to resolve issues preventing FDA
from giving final ok. 100 days for 510k or 20 after the PMA goal
PAPER 2026 QUESTIONS WITH FULL
ANSWERS VERIFIED
⩥ 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
⩥ 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
⩥ PMA Day 100. Answer: PMA deficiencies. PMA Days 90-100
⩥ Breakthrough designation request. Answer: Request breakthrough
designation for device. 60 days
⩥ Acceptance Review. Answer: application meets the submission
requirements. 14-15 days
⩥ Substantiative interaction. Answer: 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. Answer: FDA plans a meeting to address issues
with submission
⩥ MDUFA meeting. Answer: Meeting to resolve issues preventing FDA
from giving final ok. 100 days for 510k or 20 after the PMA goal
