BTEC 3317 Quiz 13

What does not apply to an approved IDE?

An approved IDE will allow approval of a device for the treatment or diagnosis of a rare disease even without effectiveness data.

An approved IDE will allow an unapproved device to be used in clinical study to obtain data in support of a 510k submission

An approved IDE will allow the marketing of an unapproved device which is significantly superior to a already marketed device

An approved IDE will allow an unapproved device to be used in clinical study to obtain data in support of a premarket approval application

An approved IDE will allow the marketing of an unapproved device which is significantly superior to a already marketed device

3 multiple choice options

All marketed devices have been proven to be safe and effective in human clinical trials.

FALSE

TRUE

FALSE

1 multiple choice option

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?

not approvable

refuse to file letter

approval order

order denying approval

order denying approval

3 multiple choice options

What is not true about the Supreme Court case involving Riegel vs Medtronic?

Rendered medical device manufacturers immune from product liability lawsuits in state courts

The Supreme Court awarded Riegel for loss of income

Court decision was based on law that device makers can't be sued by states if a device meet FDA's safety requirements

Manufacturers can still get sued for injury due to a defective device in Federal Courts

The Supreme Court awarded Riegel for loss of income

3 multiple choice options

What does not apply to Quality systems regulations for medical devices?

Manufacturers of devices where QSR compliance is not required, are also exempted from keeping complaint files

QSR applies to development and manufacturing process for Class III devices

QSRs are found in CFR21 Part 820

QSR for medical devices is equivalent to cGMP for pharmaceuticals

Manufacturers of devices where QSR compliance is not required, are also exempted from keeping complaint files

3 multiple choice options

What is not a component of design controls?

Assignment of responsibilities to manufacturing personnel

Evaluating conformance of finished design to user needs and intended use

Defining marketing strategy

Validation of device performance under actual use settings

Defining marketing strategy

3 multiple choice options

What would be the best description of human factor as a component of design control?

Many devices are naturally designed to cause bodily harm

Humans can not be trusted to use devices properly

Device design can lead to malfunction

Device design can cause harm depending on who uses it

Device design can cause harm depending on who uses it

3 multiple choice options

Center for Device and Radiological Health (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 ?

Corrective and Preventive Actions

Design controls

Records and Documents

Production and process controls

Records and Documents

3 multiple choice options

Mandatory reporting of certain device-related adverse events and product problems by device manufacturers are submitted in which online reporting site?

MedWatch

DrugAlerts.com

DeviceWatch

AdversFX.com

MedWatch

3 multiple choice options

Like drugs, advertising and promotion of approved medical devices require pre-clearance of the materials with the FDA.

TRUE

FALSE

FALSE

1 multiple choice option

What does not apply to medical devices:

Devices do not have to be metabolized to achieve their intended purposes

Most devices exert their therapeutic effects systemically

Devices do not achieve their primary intended purposes through chemical action within or on the body

Medical devices include diagnostic tests and instruments

Most devices exert their therapeutic effects systemically

3 multiple choice options

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 not-so-hip replacement that led to frequent dislocations

A contraceptive device that promoted migration of bacteria and infection of the ovaries and uterus

An artificial heart that was contaminated with tetanus toxin

An strong X-ray that caused mutations and deformities in fetuses (feti?)

A contraceptive device that promoted migration of bacteria and infection of the ovaries and uterus

3 multiple choice options

What does not apply to a 510k for a medical device?

510k should be submitted to FDA 30 days prior to marketing a device

A 510k is required when significant changes have been made to a device previously cleared through 510k

Purpose of a 510k filing is to demonstrate that a new device is substantially equivalent to a marketed device that was previously cleared through a 510k process

A 510k is more of a marketing clearance rather than an approval

510k should be submitted to FDA 30 days prior to marketing a device

3 multiple choice options

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

defibrillator

oxygen mask

artificial heart

insulin Dosing Device

oxygen mask

3 multiple choice options

An Investigational Device Exemption allows an unapproved device to be tested in human subjects. The IDE submitted to FDA is not expected to contain:

Sponsor's role during the clinical trial

Identification of investigators or trial sites

Description of the device design

Names of clinical trial patients

Names of clinical trial patients

3 multiple choice options