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Device Exam Questions And Answers 2024/2025
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Device Exam Questions And Answers 2024/2025
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Device Exam Questions And AnswersWhat is the 1991 FDA Intercenter agreement between CBER and CDRH? - ANS"Describes
product characteristics or medical indications that require a collaborative review effort by the two
centers and regulatory jurisdiction for biologic product and medical devices is clearly stated.
CBER has the responsibility for regulating all in vitro tests.
http://www.fda.gov/CombinationProducts/JurisdictionalInformation/ucm121175.htm"
How many days does the FDA have to review a special 510k, abbreviated 510k and traditional
510k? - ANS30 (special), 90 (abbreviated), 90 (traditional)
Devices that are exempt from premarket notification are: - ANSmost Class I and some Class II
A Special 510k requires _________ along with the submission with the design control
requirements - ANSDeclaration of conformity
The document required by the Quality System Regulation (QSR) that tracks each device's
manufacture by unit, lot and batch is the: - ANSDevices History Record
What is a special PMA supplement? - ANSthis is used when the change enhances or increases
the devices safety.
Where are the GMPS located for devices? - ANS21 CFR 800
FDA is authorized to regulate advertising for what types of medical devices? 1)Restricted
devices, 2) Non-restricted devices, 3) all medical devices, 4) None- the FTC oversees
advertising - ANS1) Restricted devices
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after
treatment with an approved device. This side effect is not listed in the package insert. This event
must be reported by the manufacturer to FDA no later than: 1) 5 calendar days, 2) 15 calendar
days, 3) 30 calendar days, 4) the next quarterly report - ANS1)5 calendar days (review)
While reviewing complaint files for a drug-eluting stent, a single entity combination product, it
was noticed that an adverse event had occurred and a patient was hospitalized for two
additional days. Such an adverse event was a foreseeable event and the mechanical features of
the stent contributed to the occurrence. As a regulatory professional, your decision regarding
the adverse event reporting would be: 1) Report to FDA in a 15 day alert report, 2) No action is
needed as ADE reporting is only required for serious and unexpected adverse events; this ADE
is expected so no reporting is needed. 3) report to FDA in form 3500A(MDR) within 30 days of
becoming aware of the event. 4) Report to FDA within seven calendar days of becoming aware
of the event. - ANS3) Report in 30 days on Form 3500A
,Advertising and promotional materials are required to be submitted to FDA at the time of initial
dissemination or publication for all prodcuts EXCEPT: 1) prescription drugs, 2) biologics,
3)non-restricted devices and OTC drugs, 4) none, all products require submission of advertising
and promotional material. - ANS3) non-restricted devices and OTC drugs
According to the Quality System Regulation, when an investigation of a complaint is conducted,
all of the following are requirements for inclusion in the record of the investigation except: 1) the
dates and results of the investigation, 2) the nature and details of the complaint, 3) changes in
procedures correcting quality problems, 4) any reply to the complainant - ANS3) changes in
procedures correcting quality problems
When design validation activities are being performed by a manufacturer, which element is NOT
included as a requirement under the device design validation section of QSR? 1)Conformance
to defined user needs and intended uses, 2) testing of production units under actual or
simulated use conditions, 3) software validation and risk analysis where appropriate, 4)
translation of device design into production specifications - ANS2) testing of production units
under actual or simulated use conditions
A medical device company has received a warning letter because mold has been found in two
batches of its product. The letter cites that the product is: Quarantined, Adulterated,
Misbranded, Fraudulent - ANSAdulterated
A medical manufacturer is preparing a submission that requires a Declaration of Conformity with
design control requirements. What type of submission is the manufacturer preparing to submit
to FDA? 1) A PMA 2) A special 510k, 3) an individual device exemption (IDE), 4) an annual
report for a PMA - ANS2) special 510k
A company intends to add an indication for use to a 510k device that is currently being
marketed, but which has not yet been distributed. Which type of submission is most
appropriate? 1) A PMA, 2) An investigational device exemption, 3) a special 510k 4) a traditional
or abbreviated 510k - ANS4) traditional or abbreviated 510k
An important distinction of a Humanitarian Device Exemption (HDE) is that: 1) The HDE
application must contain the same information as a PMA 2) An HDE application is not required
to contain the results of scientifically valid analytical safety studies 3) An HDE application is not
required to contain the results of scientifically valid clinical investigations demonstrating
effectiveness for its intended purpose. 4) An HDE application must be submitted within 30 days
after marketing begins. - ANS3) An HDE application is not required to contain the results of
scientifically valid clinical investigations demonstrating effectiveness for its intended purpose
When is a 510k required? - ANSrequired for most class II and some class I devices. Some class
III devices are still subject to 510(k). Required for both new devices and some modified devices.
, Must demonstrate that the device is substantially equivalent to a predicate device. Predicate
device is a legally marketed device that is not subject to a premarket approval (PMA).
What are the contents of a 510k? - ANSadministrative information, executive summary(not in
regs but in guidance) , 510k summary or 510k statement, indications for use statement, truthful
and accuracy statement, class III summary and certification, financial certification/disclosure
statement, device description, substantial equivalence, labeling, sterilization, test data (bench,
biocompatibility, animal, clinical).
What is substantial equivalence? - ANSmeans the new/modified device has the: same intended
use as predicate device and same technological characteristics as the predicate device or
different technological that don't raise new types of safety or effectiveness questions.
Performance data may be necessary to demonstrate equivalence (technological differences will
require performance data) (at least as safe and as effective ~10%-15% have clinical data). Must
have the same intended for use.
What is a predicate device? - ANSlegally marketed device that was cleared by 510k.
What is a preamemdment device? - ANSdevice from before 1976, can be used but sponsor
should really find a predicate device.
what are some modifications to a 510k that would require a new 510k? - ANSexamples that
require a new 510k submission: sterilization method, structural material, manufacturing method,
operating parameters or conditions for use, patient or user safety features, sterile barrier
packaging material, stability or expiration claims, design. When a new 510k is not submitted
sponsors should document and file a rationale as to the reasoning.
When can a traditional 510k be used? - ANScan be used for any new type of device or
modification. Used for most new devices and significant modifications in intended use or
technology. 90 day review process. ~80% of all 510ks.
When would a special 510k be used? - ANSmay be used for device modifications that do not
affect intended use or fundamental scientific technology. Company must certify compliance in
the 510k. 30 day review process. ~18% of all 510ks
When would an abbreviated 510k be used? - ANSmay be used when device complies with:
guidance document, special control, FDA recognizes consensus standard. 90 day review
process, ~3% of all 510ks- not widely used.
What are they different types of premarket approval applications? - ANS(there are several types
of PMA: traditional, Product development process, modular PMA, streamlined PMA, HDE)for
class III devices, in depth scientific review of the safety and effectiveness of a device in its own
right, review standard: reasonable assurance of safety and effectiveness, FDA holds an
advisory panel meeting for many, but not all PMAs. (Key PMA Contents: administrative
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