RAC Devices Verified Multiple Choice and
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. What is a modular PMA? - ANSWER Same content as a traditional PMA
but the sections are submitted and reviewed as the work is completed.
2. What is a PDP? - ANSWER Product Development Protocol. Alternate to
a PMA where you plan the design and timelines for product development
up front with FDA and send updates
3. When is a PMA supplement needed? - ANSWER Significant changes to
product such as indications, labels, mfg location, mfg method or quality,
sterilization, packaging, performance, stability
4. Types of PMA follow ups - ANSWER Annual report (doesn't impact S&E),
180 day (for significant changes), Special PMA (for changes that increase
S&E like added controls or removal of misleading information), 30 day
notice (changes to mfg procedure or method that impact S&E)
,5. General controls - ANSWER Establishment reg and device listing, GMP,
labels, clearance before marketing
6. 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
7. What are special controls? - ANSWER Special labeling, PMS,
performance data
8. Which devices classes generally have a 510K or PMA? - ANSWER Class 2
= 510K, Class 3= PMA
9. What is substantial equivalence? - ANSWER Same intended use,
technology, no new questions of safety/effectiveness, as safe as the
marketed device
10.All clinical studies of investigational devices need IDE approval when? -
ANSWER Before the start of the study
11.What is a step device? - ANSWER A device for less serious conditions
than a breakthrough device, but reduces risk, hazards, or improves on
safety of a current treatment
, 12.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
13.What types of IDEs require FDA approval? - ANSWER implants or
devices that present significant risk to patient safety, are life sustaining,
measure serious conditions
14.When is a supplemental IDE required? - ANSWER When there is a
change to informed consent, investigation plan, or critical study parameter
15.What types of entities are required to submit a 510k prior to marketing? -
ANSWER Domestic FG manufacturers selling into the US, foreign
manufacturer/exporter introducing to the US, spec developers,
repackager/relabeler that makes a significant change to the label
16.A 510K is required for which classes? - ANSWER Some Class I, most class
2, a small number of class 3
17.When is a traditional 510k used? - ANSWER Initial 510k or any changes.
Most common
18.Special 510(k) - ANSWER 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.
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. What is a modular PMA? - ANSWER Same content as a traditional PMA
but the sections are submitted and reviewed as the work is completed.
2. What is a PDP? - ANSWER Product Development Protocol. Alternate to
a PMA where you plan the design and timelines for product development
up front with FDA and send updates
3. When is a PMA supplement needed? - ANSWER Significant changes to
product such as indications, labels, mfg location, mfg method or quality,
sterilization, packaging, performance, stability
4. Types of PMA follow ups - ANSWER Annual report (doesn't impact S&E),
180 day (for significant changes), Special PMA (for changes that increase
S&E like added controls or removal of misleading information), 30 day
notice (changes to mfg procedure or method that impact S&E)
,5. General controls - ANSWER Establishment reg and device listing, GMP,
labels, clearance before marketing
6. 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
7. What are special controls? - ANSWER Special labeling, PMS,
performance data
8. Which devices classes generally have a 510K or PMA? - ANSWER Class 2
= 510K, Class 3= PMA
9. What is substantial equivalence? - ANSWER Same intended use,
technology, no new questions of safety/effectiveness, as safe as the
marketed device
10.All clinical studies of investigational devices need IDE approval when? -
ANSWER Before the start of the study
11.What is a step device? - ANSWER A device for less serious conditions
than a breakthrough device, but reduces risk, hazards, or improves on
safety of a current treatment
, 12.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
13.What types of IDEs require FDA approval? - ANSWER implants or
devices that present significant risk to patient safety, are life sustaining,
measure serious conditions
14.When is a supplemental IDE required? - ANSWER When there is a
change to informed consent, investigation plan, or critical study parameter
15.What types of entities are required to submit a 510k prior to marketing? -
ANSWER Domestic FG manufacturers selling into the US, foreign
manufacturer/exporter introducing to the US, spec developers,
repackager/relabeler that makes a significant change to the label
16.A 510K is required for which classes? - ANSWER Some Class I, most class
2, a small number of class 3
17.When is a traditional 510k used? - ANSWER Initial 510k or any changes.
Most common
18.Special 510(k) - ANSWER 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.
