GCP of Devices 100% Correct

GCP of Devices 100% Correct


510(k) Clearance - CORRECT ANSWER-A 510(k) clearance or premarket

notification [(510(k)] submission is a route the FDA uses to approve a medical

device. If the FDA agrees the new device is substantially equivalent to a legally

marketed device for which a premarket approval (PMA) is not required, the

manufacturer may market it immediately.

Humanitarian Device Exemption (HDE) Holder - CORRECT ANSWER-The

HDE Holder is the entity that obtains the approval of a HDE from the FDA and

may be a manufacturer, sponsor, firm, or an individual.

Humanitarian Use Device (HUD) Investigational Use - CORRECT ANSWER-

FDA uses this term to refer to a clinical investigation designed to collect safety and

effectiveness data

HUD Use - CORRECT ANSWER-The FDA uses the term "use" to refer to the

clinical use of a HUD according to its approved labeling and indications to treat or

diagnose patients.

Humanitarian Device Exemption (HDE) - CORRECT ANSWER-an application

that is similar to a premarket approval (PMA) application, but for which the

manufacturer does not need to provide evidence of efficacy. HDEs are subject to

,restrictions on profitability and can only be used in a facility after an IRB has

approved their use in that facility, except in certain emergencies.

Humanitarian Use Device (HUD) - CORRECT ANSWER-a device that is

intended to benefit patients in the treatment or diagnosis of a disease or condition

affecting not more than 8,000 individuals in the U.S. per year.

Investigational Device Exemption (IDE) - CORRECT ANSWER-refers to the

regulations under 21 CFR 812 that apply to clinical investigations. An approved

IDE means that the IRB (and FDA for significant risk [SR] devices) has approved

the sponsor's study application as meeting the requirements under 21 CFR 812

(Investigational Device Exemptions 2014).

Nonsignificant Risk (NSR) - CORRECT ANSWER-Device studies that involve a

device that does not pose a significant risk to subjects. Examples of NSR devices

include: most daily-wear contact lenses and lens solutions, ultrasonic dental scalers,

and temporary urinary catheters.

Premarket Approval (PMA) - CORRECT ANSWER-any type of premarket

approval application used to obtain FDA approval of certain types of medical

devices. It is the most stringent application for medical devices. The FDA

approves a PMA if it determines that the application contains sufficient valid

scientific evidence to provide reasonable assurance that the device is safe and

effective for its intended use(s).




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, Significant Risk - CORRECT ANSWER-Device studies that are those that involve

a SR device. Examples of SR devices include: sutures, cardiac pacemakers,

hydrocephalus shunts, and orthopedic implants.

The two-step process of obtaining an FDA marketing approval for a HUD

includes - CORRECT ANSWER-Obtaining a HUD designation then submitting a

Humanitarian Device Exemption (HDE) to the FDA

Unless the IRB or privacy board waives the requirement, HIPAA requires the

patient's authorization for the use and disclosure of protected health information

(PHI) - CORRECT ANSWER-If the use or disclosure of PHI is for the purpose

of a clinical investigation with a HUD

Clinicians using a HUD to treat or diagnose patients are responsible for -

CORRECT ANSWER-Submitting medical device reports to the HDE holder

A clinician may use a HUD without IRB approval - CORRECT ANSWER-If the

clinician determines that approval from an IRB cannot be obtained in time to

prevent serious harm or death to a patient

FDA approval of a Humanitarian Device Exemption (HDE) is based on all of the

following criteria EXCEPT - CORRECT ANSWER-Assurance of safety and

effectiveness

Which of the following statements is true regarding IRB approval of clinical use of

a HUD in a healthcare facility? - CORRECT ANSWER-The clinician obtains

initial IRB approval and ensures continuing review approval by the IRB