RAC Sample Test 2024 | 100 Questions
with 100% Correct Answers | Verified |
Latest Update | Graded A+
FDA has issued a Complete Response Letter to a company. The company views
many of the deficiencies as minor. The regulatory professional should meet with
the team to:
A. Devise a strategy for responding to all deficiencies identified by FDA
B. Devise a strategy to respond to any minor deficiencies in order to restart the
review clock
C. Inform the team a Class 1 resubmission has a six-month review clock
D. Inform the team a Class 2 resubmission has a three-month review clock -
✔✔A. Devise a strategy for responding to all deficiencies identified by FDA
Question Feedback: Resubmissions purport to answer all of the deficiencies
needing to be addressed by the applicant prior to the original application's
approval as set forth in a previous action letter.
,A drug manufacturer creates a game-based simulation to assist diabetes patients
with management of their blood glucose levels and to motivate them to adhere to
their medication schedules. The game will be based on a password protected
website that will be made available to patients when an FDA-approved drug is
prescribed to them. How will the game most likely be regulated by FDA?
A. It should be included as part of the NDA submission
B. It will be regulated as a Class I medical device
C. It will be regulated as an in vitro diagnostic product
D. It will not be an FDA regulated product - ✔✔D. It will not be an FDA
regulated product
Question Feedback: This type of "advertising" would fall under the category of a
"help-seeking" advertisement because the product is not named, although it likely
makes recommendations about actions that might be taken based on a particular
symptom, i.e., low or elevated glucose levels. Unlike drug and device promotional
labeling and prescription drug and restricted device advertising, disease
,awareness communications are not subject to the requirements of the FD&C Act
and FDA regulations.
For which device below does the Quality System Regulation require the
same procedures for identifying the control number for each unit, lot or
batch of finished devices as those mandated by the new UDI Rule?
A. Surgical gloves
B. X-ray machines
C. Pacemakers
D. Syringes - ✔✔C. Pacemakers
Question Feedback: According to 21 CFR 820.65,"Each manufacturer of a device
that is intended for surgical implant into the body or to support or sustain life and
whose failure to perform when properly used in accordance with instructions for
use provided in the labeling can be reasonably expected to result in a significant
injury to the user shall establish and maintain procedures for identifying with a
control number each unit, lot, or batch of finished devices and where appropriate
, components." The Pacemaker is a Class III implantable device and subject to 21
CFR 820.65. (Sec. 820.65 Traceability- Each manufacturer of a device that is
intended for surgical implant into the body or to support or sustain life and whose
failure to perform when properly used in accordance with instructions for use
provided in the labeling can be reasonably expected to result in a significant injury
to the user shall establish and maintain procedures for identifying with a control
number each unit, lot, or batch of finished devices and where appropriate
components. The procedures shall facilitate corrective action. Such identification
shall be documented in the DHR.)
Your company is developing a new drug to be developed and used in combination
with a cystoscopic light device for the early detection of bladder cancer. You are
asked to develop an overall regulatory strategy. The first step you undertake is:
A. Submit a Request for Designation to FDA Office of Combination Products for
determination of the lead center for primary jurisdiction for the combination
product.
B. Make a preliminary internal company determination of the combination
product's primary mode of action.
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