Biomed

Design History File (DHF)

contains the complete design history and is a major component of design control.

Device Master Records (DMR)

are essentially the “recipe” for producing a current device such as all the device specifications, process specifications, quality specifications, and packaging and labeling specifications

Device History Records (DHR)

essentially all evidence that production followed the “recipe.”; “a compilation of records containing the production history of a finished device”

Quality System Records (QSR)

records not specific to other record types and include management responsibility records such as training records.

Premarket Approval (PMA)

The FDA is required by law to find valid scientific evidence for its approval; In reality, this can be like a “game” with loopholes. FDA can ask questions which restarts the clock.

premarket notification (pmn) aka 510(k)

has no statutory review standard; process shows substantial equivalence to a previous legally marketed device or “predicate” device; intended use, safety

investigational device exemption (ide)

“to encourage the discovery and development of useful medical devices intended for human use and to maintain optimum freedom for scientific investigators in their pursuit of this purpose”; must include the statement: CAUTION– Investigational Device. Limited by Federal (or United States) law to investigational use.

institutional review boards (irb) aka ethics committee

a special committee that has regulatory responsibility for clinical trials regulated by FDA; primary purpose is to assure the protection of the rights and welfare in clinical trials

for each individual country

The EU does not a have a central federal government enacting statutes; rather, the statutes exist….

directives

Instead the EU enacts ____and the individual country laws should harmonize with these

conformite europeene (CE)

Approval in the EU results in ____ that means the product may be marketed in EU countries

competent authorities and notified bodies

• The EU system has two types of entities in the regulation process.

follow the ENs, but the normal route is to comply

The use of the EU standards is different than in the US in that a company is not required to….

engineering

EU is more “____” oriented

therapy

fda is more ____ oriented

its intended purpose which is determined by what it “claims.

What is the most important criterion for determining the legal status of a medical device?

Institutional Review Board

What group of persons is responsible to review, approve or oversee biomedical research involving human subjects and whose primary purpose is to assure the protection of the rights and welfare of human subjects in a clinical trial?

systemic quality issues exist for a manufacturer

CAPA systems are heavily inspected by FDA since this relates to whether….

• define what is meant by medical device

• Understand the nature of the FDA

• Gain a working knowledge of Quality System Regulations

• Identify basic requirements for testing

objectives

Protecting the rights of the subjects; Assuring the integrity of the study data

two key general issues regarding regulations for testing on human subjects

Warning letters

_________ are given for severe, egregious or systematic errors.

Safety and intended use

A predicate device should be used to show substantial equivalence in which two areas?

Medical Device Reporting

Complaints are evaluated to determine if they should be reported to FDA under ________

1. Extensive regulations for the entire design process

2. Biological uncertainty of medical design

3. Mulitidisiplinary nature

Which of the following is a difference of device design to other engineering disciplines.

cosmetic

Intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the body for cleansing, beautifying, promoting attractiveness, or altering the appearance

CDRH

What is the primary division for medical devices?

medical device

_______ means an instrument, apparatus, implement, machine, contrivance, implant, or other related article that is recognized in the official National Formulary, is intended for use in diagnosis, and is intended to affect the structure of the body

fda

The ____ is a large federal agency with over 10,000 employees nationwide and serves a consumer protection organization

Medical Devices Amendments of 1976

“Modern” control of medical devices resulted when this act was amended in 1976 by the _____________________.

undergo the PMA process.

Class III devices are considered to be the riskiest devices and therefore must …

PMN/510(k) process

Class II devices are considered to be moderate risk and therefore undergo the …...

no formal approval or clearance process.

Class I devices are considered to be low risk and therefore require ….

predicate device

A previous legally marketed device that can be shown to have substantial equivalence to a device going through the 510(k) process

bench testing

Testing done in a lab that involves neither animals nor humans

f

t/f Class III devices are exempt from following the general controls established by QSR.

t

t/f A quality policy is required by FDA for a medical device company

t

t/f Clinical data is the primary basis for the FDA determining substantial equivalence for 510(k) submission.

f

t/f A medical device company is required to notify FDA of all complaints it receives regarding it products.

t

t/f A GLP study must follow a preapproved written protocol for testing medical devices on animals.

t

t/f Prior to all clinical testing of medical devices on humans, the entire process of informed consent must be followed without exception.

t

t/f An inaccurate or untraceable label affixed to the packaging of a medical device renders the medical device as adulterated.

t

t/f A warning letter is issued to a medical device company for severe or systematic errors in their quality control.

t

t/f Any significant risk medical device that is going to be tested on humans must have Premarket Approval (PMA) from FDA.

legal

legal/illegal for informed consent doc: As a research participant you have the right to be informed of the nature and purpose of the experiment and the right to be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits.

legal

legal/illegal for informed consent doc: As a research participant you have the right to be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.

FDCA of 1938

prohibited “adulterated” or misbranded items from commerce.