Medical Device Regulation Flashcards
What does not apply to medical devices?
A) Devices are intended for use in the diagnosis, cure, mitigation, prevention or treatment of disease
B) Not all marketed devices have been proven to be safe and effective in human clinical trials.
C) FDA’s Center for Device and Radiological Health is mainly responsible for regulating the manufacture and approval of medical devices
D) Medical devices have longer life cycles (5-10 years) in the marketplace as compared to drugs
E) Devices do not achieve their primary intended purposes through chemical action within or on the body
D) Medical devices have longer life cycles (5-10 years) in the marketplace as compared to drugs
What does not apply to the Supreme Court case involving Riegel vs Medtronic?
A) Court decision was based on law that device makers can’t be sued by states if a device meet FDA’s safety requirements
B) Rendered medical device manufacturers immune from product liability lawsuits in state courts
C) The Supreme Court awarded Riegel for loss of income
D) Manufacturers can still get sued for injury due to a defective device in Federal Courts
E) The Supreme Court ruled in favor of Medtronic
C) The Supreme Court awarded Riegel for loss of income
What does not apply to Quality systems regulations for medical devices?
A) Manufacturers of devices where QSR compliance is not required, are also exempted from keeping complaint files
B) QSR for medical devices is equivalent to cGMP for pharmaceuticals
C) QSR applies to development and manufacturing process for Class III devices
D) Certain devices are exempted from QSR
E) QSRs are found in CFR21 Part 820
A) Manufacturers of devices where QSR compliance is not required, are also exempted from keeping complaint files
What is not a component of design controls?
A) Evaluating conformance of finished design to user needs and intended use
B) Describing the intended use of the device
C) Defining marketing strategy
D) Validation of device performance under actual use settings
E) Assignment of responsibilities to manufacturing personnel
C) Defining marketing strategy
What would be the best description of human factor as a component of design control?
A) Not all humans know the use of factors in math
B) Device design can lead to malfunction
C) Many devices are naturally designed to cause bodily harm
D) Humans can not be trusted to use devices properly
E) Device design can cause harm depending on who uses it
E) Device design can cause harm depending on who uses it
CDRH follows a seven system quality system inspection technique (QSIT) to assess a device manufacturers compliance with QSRs. Which is not one of the four major or foundation systems that are the main focus of CDRH inspections ?
A) Management
B) Corrective and Preventive Actions
C) Records and Documents
D) Design controls
E) Production and process controls
C) Records and Documents
Mandatory reporting of certain device-related adverse events and product problems by device manufacturers are submitted in which online reporting site?
A) MedWatch
B) DrugAlerts.com
C) AdversFX.com
D) SmartWatch
E) DeviceWatch
A) MedWatch
Like drugs, advertising and promotion of approved medical devices require pre-clearance of the materials with the FDA.
A) FALSE
B) TRUE
A) FALSE
What crisis led to the passage of the Medical Device Regulation Act of 1976, a law that gave the FDA authority to regulate the safety and effectiveness of devices?
A) A not-so-hip replacement that led to frequent dislocations
B) An strong X-ray that caused mutations and deformities in fetuses (feti?)
C) An exploding vaping device
D) An artificial heart that was contaminated with tetanus toxin
E) A contraceptive device that promoted migration of bacteria and infection of the ovaries and uterus
E) A contraceptive device that promoted migration of bacteria and infection of the ovaries and uterus
What does not apply to a 510k for a medical device?
A) 510k is more of a marketing clearance rather than an approval
B) Demonstration of safety through clinical trials is not required for 510k approval by the FDA
C) FDA’s 510k evaluation process takes longer than getting a pre-market approval
D) A 510k submission is required when the new device is substantially different from a related device that was previously cleared through 510k
E) 510k is normally submitted to FDA 90 days prior to marketing a device
C) FDA’s 510k evaluation process takes longer than getting a pre-market approval
Which of these devices poses minimal health risks to patients and is least likely to be classified as a Class III device? Use FDA’s product classification tool to find the answer. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
A) insulin Dosing Device
B) pregnancy test kit
C) Brain Stimulator For Epilepsy
D) defibrillator
E) artificial heart
B) pregnancy test kit
An Investigational Device Exemption allows an unapproved device to be tested in human subjects. The IDE submitted to FDA is not expected to contain:
A) Identification of investigators or trial sites
B) Sponsors role during the clinical trial
C) Statistical analysis of data obtained from clinical testing of the device
D) Description of the device design
E) Clinical study protocol
C) Statistical analysis of data obtained from clinical testing of the device
All marketed devices have been proven to be safe and effective in human clinical trials.
A) FALSE
B) TRUE
A) FALSE
Six months after CDRH accepts the filing of PMA application for a device, what type of letter will CDRH send the manufacturer if the application meets regulatory requirements and the device is cleared for marketing?
A) approval order
B) approvable letter
C) refuse to file letter
D) not approvable
E) direct-to-consumer letter
A) approval order
Six months after CDRH accepts the filing of PMA application for a device, what type of letter will CDRH send the manufacturer if the manufacturer refuses to allow the FDA to examine all records which are relevant to the application?
A) refuse to file letter
B) order denying approval
C) approval order
D) approvable letter
E) not approvable
B) order denying approval
