Quiz: Medical Device Submissions 1 -
(PMA,HDE)
Terms in this set (60)
How are changes or revisions to E)
an original PMA application
submitted to FDA?
A) Through a PMA Supplement
B) Through a PMA Amendment
C) Through a New PMA Filing
D) Through a PMA Withdrawal
E)Through a PMA
Supplement or
Amendment
According to PDUFA C) 180 days
performance goals, in how
many days should the FDA Explanation: Under PDUFA performance goals, the FDA is
provide the PMA applicant a required to provide a decision on the PMA application within
decision? 180 days, achieving this 90% of the time.
A) 90 days
B) 120 days
C) 180 days
D) 365 days
What is a Modular PMA? B) A PMA broken down into separate modules for early review
A) A PMA that combines
multiple applications Explanation: A Modular PMA allows the applicant to
into one submit a PMA in well- delineated components (modules),
B) A PMA broken down facilitating early FDA review of each module as it is
into separate modules completed, rather than waiting for a complete
for early review submission.
C) A PMA that only
focuses on
manufacturing
processes
D) A PMA submitted without
clinical data
,What is the target FDA review C) 90 days
time for each module of a
Modular PMA? Explanation: The FDA aims to complete its review of each
A) 30 days module of a Modular PMA within 90 days.
B) 60 days
C) 90 days
D) 120 days
How is a Humanitarian Use B) A device intended for fewer than 8,000 individuals per year
Device (HUD) defined?
A) A device used only for Explanation: A HUD is defined as a medical device intended
children
to benefit patients in the treatment or diagnosis of a disease
B) A device intended for fewer
affecting not more than 8,000 individuals in the
than 8,000 individuals per
U.S. per year, as per Section 3052 of the 21st Century Cures Act.
year
C) A device that is used in clinical
trials only
D) A device that must show
effectiveness data for
approval
What are the six types of PMA B) 30-Day Supplement, Real-Time Supplement, Special PMA
supplements? Supplement, PMA Panel Supplement, 135-Day Supplement,
A) Real Time Supplement, Traditional PMA Supplement
Special PMA Supplement,
PMA Panel Supplement Explanation: The six types of PMA
B) 30-Day Supplement, supplements include: 30-Day
Real-Time Supplement, Supplement
Special PMA Supplement, Real-Time
PMA Panel Supplement, Supplement
135-Day Supplement, Special PMA
Traditional PMA Supplement Supplement PMA
C) Minor Changes, Major Panel
Changes, No Changes, Supplement
New Applications 135-Day
D) New Device Supplements, Supplement
Amendment Supplements, Traditional PMA Supplement
Field Safety Notices
What is the primary focus of the B) To introduce significant changes to manufacturing processes
135-Day Supplement?
A) To expedite approvals for
innovative devices
B) To introduce significant
changes to
manufacturing
processes
, C) To allow modifications
with minimal safety risks
D) To streamline review
processes for nonclinical
data
Which organization is primarily C
responsible for evaluating
PMA modifications according Explanation: The Center for Devices and Radiological Health
to the guidance? (CDRH) is responsible for evaluating medical devices and
A) The Center for Drug modifications that fall under the PMA process.
Evaluation and Research
(CDER)
B) The Office of the
Inspector General (OIG)
C) The Center for Devices and
Radiological Health (CDRH)
D) The Center for Food Safety
and Applied Nutrition
(CFSAN)
(PMA,HDE)
Terms in this set (60)
How are changes or revisions to E)
an original PMA application
submitted to FDA?
A) Through a PMA Supplement
B) Through a PMA Amendment
C) Through a New PMA Filing
D) Through a PMA Withdrawal
E)Through a PMA
Supplement or
Amendment
According to PDUFA C) 180 days
performance goals, in how
many days should the FDA Explanation: Under PDUFA performance goals, the FDA is
provide the PMA applicant a required to provide a decision on the PMA application within
decision? 180 days, achieving this 90% of the time.
A) 90 days
B) 120 days
C) 180 days
D) 365 days
What is a Modular PMA? B) A PMA broken down into separate modules for early review
A) A PMA that combines
multiple applications Explanation: A Modular PMA allows the applicant to
into one submit a PMA in well- delineated components (modules),
B) A PMA broken down facilitating early FDA review of each module as it is
into separate modules completed, rather than waiting for a complete
for early review submission.
C) A PMA that only
focuses on
manufacturing
processes
D) A PMA submitted without
clinical data
,What is the target FDA review C) 90 days
time for each module of a
Modular PMA? Explanation: The FDA aims to complete its review of each
A) 30 days module of a Modular PMA within 90 days.
B) 60 days
C) 90 days
D) 120 days
How is a Humanitarian Use B) A device intended for fewer than 8,000 individuals per year
Device (HUD) defined?
A) A device used only for Explanation: A HUD is defined as a medical device intended
children
to benefit patients in the treatment or diagnosis of a disease
B) A device intended for fewer
affecting not more than 8,000 individuals in the
than 8,000 individuals per
U.S. per year, as per Section 3052 of the 21st Century Cures Act.
year
C) A device that is used in clinical
trials only
D) A device that must show
effectiveness data for
approval
What are the six types of PMA B) 30-Day Supplement, Real-Time Supplement, Special PMA
supplements? Supplement, PMA Panel Supplement, 135-Day Supplement,
A) Real Time Supplement, Traditional PMA Supplement
Special PMA Supplement,
PMA Panel Supplement Explanation: The six types of PMA
B) 30-Day Supplement, supplements include: 30-Day
Real-Time Supplement, Supplement
Special PMA Supplement, Real-Time
PMA Panel Supplement, Supplement
135-Day Supplement, Special PMA
Traditional PMA Supplement Supplement PMA
C) Minor Changes, Major Panel
Changes, No Changes, Supplement
New Applications 135-Day
D) New Device Supplements, Supplement
Amendment Supplements, Traditional PMA Supplement
Field Safety Notices
What is the primary focus of the B) To introduce significant changes to manufacturing processes
135-Day Supplement?
A) To expedite approvals for
innovative devices
B) To introduce significant
changes to
manufacturing
processes
, C) To allow modifications
with minimal safety risks
D) To streamline review
processes for nonclinical
data
Which organization is primarily C
responsible for evaluating
PMA modifications according Explanation: The Center for Devices and Radiological Health
to the guidance? (CDRH) is responsible for evaluating medical devices and
A) The Center for Drug modifications that fall under the PMA process.
Evaluation and Research
(CDER)
B) The Office of the
Inspector General (OIG)
C) The Center for Devices and
Radiological Health (CDRH)
D) The Center for Food Safety
and Applied Nutrition
(CFSAN)
