BME 3801 BioDesign Final

Lakukan tugas rumah & ujian kamu dengan baik sekarang menggunakan Quizwiz!

According to 21 CFR Part 820.30h what is design transfer?

-Correctly translated into production

According to 21 CFR Part 820.30d what is design output?

-Define design output, approval, documented

According to 21 CFR Part 820.30b what is design and development planning?

-Define or reference activities -Define responsibilities -Define group interfaces -Documented

According to 21 CFR Part 820.30c what is design input?

-Design requirements -Needs of user and patient -Approval -Documented

Summarize all sections in 21 CFR 820.30

(a) General. (1) Each manufacturer of any class III or class II device, andthe class I devices listed in paragraph (a)(2) of this section, shallestablish and maintain procedures to control the design of the device inorder to ensure that specified design requirements are met.(2) The following class I devices are subject to design controls:(i) Devices automated with computer software; and(ii) The devices listed in the following chart. Section Device868.6810 Catheter, Tracheobronchial Suction.878.4460 Glove, Surgeon's.880.6760 Restraint, Protective.892.5650 System, Applicator, Radionuclide, Manual.892.5740 Source, Radionuclide Teletherapy. (b) Design and development planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves. (c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented. (d) Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented. (e) Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF). (f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.(g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s)performing the validation, shall be documented in the DHF. (h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications .(i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation. (j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

According to 21 CFR Part 820.30i what is design changes?

-Identification, validation, verification, review and approval of design changes -Documented

According to 21 CFR Part 820.30f what is design verification?

-Procedures for verifying device design -Confirm output = input -Documented

According to 21 CFR Part 820.30g what is design validation?

-Production units -Defined operating conditions -Ensure devices conform to user needs and intended uses -Documented

Why use design control?

-Systematic -Team based -Customer focused -Robust -Required by law

How many years does a utility patent last from the non-provisional patent filing date?

20

What is the duration (in years) of a patent from the earliest effective filing date in the United States of America?

20

What section is design control in CFR

21 CFR 820.30

What classes do general controls pertain to?

All

How can properly implemented GD&T save money in the manufacturing process?

Better definition of the design requirements, increased availability of tolerances, better communication between design, manufacturing and inspection, fewer engineering changes

What are the three regions of the risk index graph?

Broadly acceptable, ALARP region, intolerable region

What class of medical devices does an adhesive bandage belong to?

Class I

What devices classes have to follow design control?

Class I, II, III

What class of medical devices does a replacement heart valve belong to?

Class III

What branch of the US government is responsible for the regulation of medical devices?

Department of Health and Human Services

_____ is used to identify a failure/safety hazard and all possible ways to create that hazard, while _____ assumes a basic defect on a component level, assesses the effect and identifies potential solutions.

FTA, FMEA

Are all Class I devices exempt from special controls that apply to Class II and III devices? True or False

False

True or False? A needs statement should have a conceptual solution embedded into it.

False

What are class I devices subjected to?

General controls

What do general controls cover?

Manufacturing registration, label devices per regulations, submit premarket notification 510k unless exempt, manufacture devices per cGMP (Current good manufacturing practice)

What are class III devices subjected to?

Premarket approval, scientific reviews, general controls

What is 21 CFR 820?

Quality System Regulations

Product design specifications must be specific in translating and interpreting __________ into engineering, quantifiable terms.

Requirements

Broadly acceptable level of risk determination is driven by:

Societal values

What do special controls include?

Special labeling requirements, mandatory performance standards, conformance with certain FDA guidelines, human clinical trials, postmarket surveillance

What FDA center regulates medical devices?

The center for devices and radiological health (CDRH)

If you want to know what is actually covered by a granted patent, what should you look at?

The claims

What are examples of class I devices?

Tongue depressors, bedpans, bandages, examination gloves, hand held surgical instruments

True or False? Class II electrical instruments use "live" and "neutral" connections only.

True

True or False? Requirements are often measurable.

True

Devices are regulated by the FDA according to the: a) risks posed by their use b) cost of development c) potential for profit d) number of people affected by the ailment being treated

a

A design review is an examination of a design or process that is: (choose all that apply) a) Documented b) An ongoing part of the entire design process c) A means to get a meeting with your boss d) Used to bring a cross-functional team to the table to ensure the design team has not missed something overall e) A discussion over dinner and or/drinks f) Recommended by 21 CFR 820.30(c)

a, b, d

Choose all that apply. A device is considered substantially equivalent (SE) if it: 1) has the same intended use as the predicate and the same technological characteristics b) has the same intended use as the predicate but different technological characteristics c) has a different intended use as the predicate but the same technological characteristics d) has a different intended use as the predicate but the same technological characteristics and the information submitted to the FDA does not raise new questions about safety and efficacy and demonstrates the device is at least as safe and effective as the legally marketed device e) has the same intended use as the predicate but different technological characteristics and the information submitted to the FDA does not raise new questions about safety and efficacy and demonstrates the device is at least as safe and effective as the legally marketed device

a, e

What is the significance of a traceability matrix in medical device design? (Choose all that apply) a) Basic design control tool used to establish clear linkages between design inputs, outputs, verifications, validations, and risk analyses b) Useful only during design verification activities c) Keeps your boss off your back throughout the design process d) Ensures that all customers will be happy with the product e) Required by the FDA

a, e

A design project does not have to contain the following? a) A signature block for responsible parties b) Gantt charts c) An assignment of responsibilities d) Subprojects, tasks, and milestones

b

All of the following are characteristic of a patent drawing except: a) Number, letters, and reference characters b) Detailed annotation c) Shading d) Black and White e) Variety of views f) Scale

b

Design output includes: a) Specifications, verification test data b) Validated manufacturing protocols c) Labeling and packaging specifications d) User demographics

c

Sections 201(g) and 201(h) of the FD&C Act provide definitions for the terms "drug" and "device". What is the main difference between the two? a) Devices are not meant to be ingested b) There is no difference between the two c) Drug achieves its effect through chemical action and are dependent upon being metabolized d) Devices are intended for the diagnosis of disease

c

Which of the following is NOT part of FDA Design control? a) Manufacturing b) User Needs c) Regulatory Approval d) Design Reviews e) Design Testing

c

Which of the following statements is true? a) Leakage currents are measured during both normal and multiple fault conditions b) Leakage currents are not measured until the instrument malfunctions c) Leakage currents are measured during both normal and single fault conditions d) Leakage currents are measured during all normal and abnormal fault conditions

c

A Class II device requires: a) General exemption b) Special exemption c) Premarket notification d) Premarket approval e) All of the above

d

Design input does not include: a) Cost b) Safety c) Identification of Users d) Clinical Trial Protocols

d

Electrical shock may result from: a) One part of the body being in contact with a conductive surface b) A different part of the same body being in contact with a second conductive surface c) A voltage source driving current through the body between those two points of contacts d) Conditions a through c must occur simultaneously e) Conditions a through c must occur separately

d

The minimum requirements for obtaining a patent are that the invention must be: a) novel b) non-obvious or include an inventive step c) a and b d) a, b, and c

d

Choose all that apply. Which of the following devices are not exempt from 510(k) notification? a) Veterinary device b) Custom devices (intended for use by a single patient) c) Finished devices not sold in the US d) Preamendment devices e) All are exempt

e

Which of the following is NOT considered intellectual property? a) Patent b) Trademark c) Trade Secret d) Copyright e) All are considered intellectual property

e

Before deciding on a project and developing design requirements, the team must: 1) Define the ______ 2) Define the ______

problem, need

According to 21 CFR Part 820.30j what is design history file?

-Establish and maintain DHF -Demonstrate design control -Documented

According to 21 CFR Part 820.30e what is design review?

-Formal reviews -Documented

What are design requirements?

-Voice of the customer: Identification of user and user needs -High level engineering analysis -Analysis of Market -Defining the requirements

What are the four laws of design control?

1) Document Everything - DHF 2) Inputs = Outputs - Acceptance criteria 3) Trust but verify and validate everything - verify acceptance criteria and specifications. Validate we are making what customer asked for 4) Transfer is inevitable - repeatedly manufacturing the product

Which of the following ISO standards applies to risk management?

14971

What class of medical devices does a surgical drape belong to?

Class II

The phrase the "voice of the customer" refers to what aspect of design and development:

Development of user needs

What is class 1 device?

Device that present minimal potential for harm to the user and are often simpler in design that class II and class III devices.

What is a medical device?

Device which is: -Recognized in official National formulary or US pharmacopoeia -Intended for use in the diagnosis, treatment, or prevention of disease or other conditions -Intended to affect the structure or function of the body and which does not achieve primary function through chemical action within the body

What are class III devices?

Devices for which sufficient information exists to assure safety and effectiveness solely through general or special controls

What are class II devices?

Devices held to a higher level of assurance that class I devices that they will perform as indicated and not cause injury or harm to patient or user.

What does ANSI Y.14.5 (Now renamed to ASME Y14.5) relate to?

Dimensioning and tolerancing

What is included in high level engineering analysis?

Early prototypes, sketches and drawings

What is the FDA's responsibility?

Ensuring that no adulterated or misbranded food, drug, or medical devices enters into interstate commerce.

What is design validation?

Ensuring that the developed medical device conforms to user needs and intended uses

What branch of government is the FDA in?

Executive

Rank the following applied part types in the order of increasing electrical protection: BF B CF

F>BF>CF

True or False? 510(k) submissions never require any data collected in clinical investigations.

False

True or False? Class III devices are never eligible for 510(k) clearance.

False

True or False? Grounding is not required for Class I equipment.

False

True or False? It's OK for a requirement to be vague, ambiguous, or conflicting.

False

True or False? Over 90% of the devices placed on the market in the US are cleared by the FDA after the review of a PMA (pre-market approval).

False

True or False? Patents are automatically enforced by the USPTO.

False

True or False? Planning is not mandated by 21 CFR 820.30, but it will help you complete the project on time, within budget, and using the allocated resources.

False

True or False? Reproducibility and precision imply accuracy.

False

True or False? Software cannot be considered a medical device.

False

What are class II devices subjected to?

General controls and special controls

What are examples of class III devices?

Heart valve, silicone gel breast implant, pacemaker

A specification consists of a _____ and a ____

Metric, Value

At what point during the medical device design process must risk management take place?

Ongoing during the entire process

Risk Index (R) = ____ index x _____ index

Severity, probability

True or False? A need statement should have a quantifiable metric associated with it.

True

True or False? Accuracy is a measure of the total error.

True

True or False? After the patent terms expire, the invention becomes 'public domain' and may be made, used or sold by anyone without licensing.

True

True or False? All medical devices are subject to general controls.

True

What are examples of class II devices?

X-ray, PACS, powered wheelchairs, infusion pumps

What are the sections in 21 CFR 820.30?

a) General b) Design Development and Planning c) Design Input d) Design Output e) Design Review f) Design Verification g) Design Validation h) Design Transfer i) Design Change j) Design History File

Define each of the following statements as a need, requirement, or specification: a) Audible by someone with unimpaired hearing in a mixed frequency 80 dB environment b) 1 W speaker driven at 3V, 2000Hz for 2 sec/1 sec intermittent c) Audible in a noisy environment

a) Requirement b) Specification c) Need

Pick all that apply. Which of the following are a type of patent? a) Design patent b) Plant patent c) Utility patent d) Copyright patent e) Trade secret patent

a, b, c

What's the purpose for conducting a risk analysis? (Choose all that apply) a) Required in PMA and 510(k) filings b) Required by law c) Reduce product liability and damage awards d) Decrease clinician malpractice insurance rates e) Reduce the cost of design and development f) Decrease manufacturing cost g) Reduce probability of having a recall h) Shorten time to market

a, b, c, g

Which of the following are considered to be the minimal requirements for general controls? (pick all that are applicable) a) Manufacturing per cGMP b) Device labeling c) Post market surveillance d) Manufacturing registration e) Human clinical trials

a, b, d

Electrical safety must be tested: (Choose all that apply): a) During routine planned preventative maintenance b) Any time you feel like doing it c) On newly acquired equipment prior to being accepted for use d) After repairs have been carried out on equipment e) Before each use

a, c, d

Choose all the apply. Class I devices are not intended to a) Be used in supporting or sustaining life b) Be ingested or inhaled c) Be administered by a physician d) Present a potential unreasonable risk of illness or injury e) Be of importance in preventing impairment of human life

a, d, e

The objectives of a design review include all of the following except: (choose all that apply): a) Include individual(s) who does not have direct responsibility for the design stage being reviewed b) Educated or bring new employees or unprepared employees up to speed c) Evaluate individual team member contributions to the project d) Evaluate the return on investment (ROI) e) Confirm and assure that the device is safe and effective f) Evaluate the adequacy of the design requirements

b, c

Why do medical devices fail and therefore impose risk on the user? (Choose all that apply) a) Lack of FDA approval b) Quality assurance deficiencies c) Lack of coverage from insurance company d) Design deficiencies e) Misuse f) High cost

b, d, e

Why would you use design control in the development of a medical device? (Choose all that apply) a) Reduces cost b) Customer focused c) Will ensure you don't get sued d) Allows multidisciplinary input e) Required by law f) Leads to a 100% risk free device g) Systematic approach

b, d, e, g

Leakage current is (choose all that apply) a) The current that flows in the neutral conductor b) The current that passes through the patient's body in the course of device operation c) The current consumed during device operation d) The current that flows in the live conductor e) The current that passes through the caregiver's body in the course of device operation

b, e

Put the following components of the design process in order: a) Prototype is built to specifications b) Verification testing ensures prototype (specifications) meets requirements c) Specifications provide the details to build d) User needs in user terms e) Marketing requirements are measurable

d, e, c, a, b


Set pelajaran terkait

Ch 7 Legal Aspects/Professionalism

View Set

AP Euro: Unit 3 Absolutism Review

View Set

Rekenen breuken procenten kommagetallen

View Set

Political Globalization Midterm II

View Set

PY 361 Chapter 9: Internal Regulation

View Set