Question
Answer
Explanation
A startup has created an implantable cardiac
device that provides real-time electrochemical
monitoring of heart function. The technology is
entirely new, and no predicate device exists. The
device is classified as Class III due to its high-risk
nature.
What is the most appropriate premarket
submission for this device?
A) 510(k)
B) PMA
C) De Novo
D) IDE
B) PMA
Product requiring PMAs are Class III devices are high risk
devices that pose a significant risk of illness or injury, or
devices found not substantially equivalent to Class I and
II predicate through the 510(k) process. The PMA
process is more involved and includes the submission of
clinical data to support claims made for the device.
De Novo cannot be the correct answer as a De Novo
classification is used for novel, low- to moderate-risk
devices that do not have a legally marketed predicate.
A company develops a wearable sensor that
monitors hydration levels in real-time and
provides alerts to prevent dehydration. The
device has no existing predicate, but the
company believes it poses low to moderate risk
and does not meet the criteria for Class III.
Which premarket pathway should they pursue?
A) 510(k)
B) PMA
C) De Novo
D) IDE
C) De Novo
The De Novo pathway is designed for low to moderate-
risk devices that do not have a predicate but do not pose
high risk. Since the hydration monitoring device is novel
but presents minimal safety concerns, the company
should submit a De Novo request. If granted, this device
would be classified as Class I or II and could serve as a
predicate for future 510(k) submissions.
A small biotech company has designed a
neurostimulation implant that reduces tremors
in patients with a rare genetic disorder. The
disorder affects fewer than 8,000 individuals in
the U.S. each year. The company wants to get
the device to market quickly without proving
effectiveness through large-scale clinical trials.
Which pathway is the best regulatory option?
A) PMA
B) HDE
C) 510(k)
D) De Novo
B) HDE
Explanation:
The Humanitarian Device Exemption (HDE) applies to
devices intended to treat or diagnose rare diseases
affecting fewer than 8,000 people in the U.S. per year.
Unlike PMA, HDE does not require proof of effectiveness
but must still demonstrate safety. Since this device
meets these criteria, an HDE submission is appropriate.
A manufacturer is developing a next-generation
knee implant that features a bioresorbable
coating to enhance post-surgical recovery.
Because this technology has never been used in
orthopedic implants before, the FDA classifies
the device as significant risk.
What regulatory process must the company
follow before conducting a clinical trial in the
U.S.?
A) 510(k) submission
B) Humanitarian Device Exemption (HDE)
C) Investigational Device Exemption (IDE)
D) Real-Time Supplement
C) Investigational Device Exemption (IDE)
Explanation:
An Investigational Device Exemption (IDE) allows a
company to conduct clinical trials on a device that has
not yet been FDA-approved. Since the knee implant uses
a new material and is classified as significant risk, an IDE
is required before clinical trials can begin in the U.S.
A company submits a 510(k) notification for a
new surgical stapler that is substantially
equivalent to a legally marketed predicate. The
company wants to know how long it will take to
receive clearance before they can market their
product.
What is the standard review timeline for a 510(k)
submission?
A) 30 days
B) 90 days
C) 180 days
D) 12 months
B) 90 days
A medical device company receives PMA
approval for a Class III orthopedic implant. A
year later, the company wants to add a new
manufacturing site for the device.
Which type of PMA Supplement is required?
A) Panel-Track Supplement
B) 30-Day Notice
C) 180-Day Supplement
D) Real-Time Supplement
C) 180-Day Supplement
Explanation:
A 180-Day Supplement is required when making
significant changes to a PMA-approved device, such as
adding a new manufacturing site. The FDA reviews the
supplement within 180 days to ensure that the changes
do not impact the device's safety or effectiveness.
A company receives HDE approval for a new
pediatric heart valve. They are considering mass
production and international sales but are
unsure about U.S. sales limits under HDE.
What is the maximum number of units that can
be sold per year under an HDE?
A) 4,000
B) 8,000
C) 10,000
D) Unlimited
A) 4,000 RAC Book page 157.
A company receives De Novo approval for a
novel wound-healing device. They are
considering future expansions and partnerships
with other companies.
Can future manufacturers use this device as a
predicate for their 510(k) submissions?
A) Yes
B) No
A) Yes
Explanation:
Once a De Novo request is granted, the device is
classified as either Class I or Class II, meaning future
devices can reference it as a predicate in 510(k)
submissions.
