Material for Exam 1
What/when was the birth of the FDA?
1862 - President Lincoln - Dept. of Chemistry - birth of FDA
What/when was the founding of the FDA?
1906 - Roosevelt - Pure Food and Drug Act - founding of FDA
Give an example of when and why the FDA began to oversee food, drugs, and cosmetics.
1937 - Over 100 people died after consuming a raspberry flavored sulfa elixir which consisted of 70% ethylene glycol (antifreeze) The Food, Drug and Cosmetic Act of 1938 gave authority to the FDA to oversee the safety of food, drugs and cosmetics
Rank the following applied part types in the order of increasing electrical protection: BF B CF
2 1 3
How many years does a utility patent last from the non-provisional patent filing date?
20 years
What is the duration of a patent from the earliest effective filing date in the US?
20 years
Learn to translate requirements into MR doc.
21 CFR Part 820.3(c): Design input Establish and maintain procedures to ensure that design requirements meet user needs Address incomplete, ambiguous, or conflicting requirement Be documented Approved in design review Review should be documented Takes problem statement and translates the problem into a need Measureable Parts of MR Doc Problem Statement User Needs Product Description/Function Intended Users/Uses Environments of Use Market Size/ Sales Price Estimate/Competitive Product Analysis Regulatory Requirements Voluntary Standards Functional Requirements/Physical and Performance Requirements/Human and System Interfacing Requirements Conceptual Design
Out of the following, which devices are not exempt from 510k clearance? Veterinary devices Custom devices (intended for use by a single patient) Finished devices not sold in the US Preamendment devices
All of these are exempt
Out of the following, which are not considered intellectual property: Trade secret Trademark Patent Copyright
All of which are considered intellectual property
What are the 3 minimum requirements for obtaining a patent?
An invention must be: Novel Non-obvious or include an inventive map Useful or capable of industrial application
Describe Marketing requirements:
Basis for specs, prototype development, and verification/validation testing Considers user needs, safety, ergonomics, performance, regulatory standards Identify additional requirements
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.
Which center do we care about?
Center for Devices and Radiological Health (CDRH)
Class I devices are not intended to what (3)? What do they intend to do (2)?
Class I devices do not intend to: To be used in supporting or sustaining life To present a potential unreasonable risk or illness or injury To be of importance in preventing impairment to human life But, they do intend to: To possibly be ingested or inhaled To be administered by a physician
Define Class I:
Class I: General Controls Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, hand-held surgical instruments and other common types of equipment. Subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures. These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage.
Define Class II:
Class II: General Controls w/ Special Controls Devices are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps and surgical drapes. General controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance.
Define Class III:
Class III: General Controls and Premarket Approval A Class III devices is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls. Example devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."
How to successfully work in a team environment
Clear goals: inspire members Collaborative climate: Increase knowledge sharing Principled leadership Strong interpersonal relationships Open to discussing issues: Long and short term Trust Open to criticism among members Cohesion
Describe a DHF:
Contains all information to provide evidence that all project phases and regulatory requirements have been met
List 4 reasons why you would use design control in the development of a medical device:
Customer focused Allows multidisciplinary input Required by law Systematic approach robust
What should be included in the Device History Record?
Date of manufacture Quantity manufactured Quantity released for distribution Acceptance records to match back to DMR Primary identification label and labeling used for each unit Any device identification and control numbers used
What are the keys to a good project plan?
Dates, who, what, when.
Design output?
Define design output Approval Documented
What 4 things need to be defined or done within the Design and Development plan?
Define or reference activities Define responsiblities Define group interfaces Must be well documented
Documentation required by QSR:
Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) Technical File
What is involved in design input?
Design requirements Needs of user and patient Approval Documented
Describe Design specifications:
Detailed embodiment of the design in the design input phase of device development Gateway to validation/verification testing Mitigate identified hazards and risks
Describe Patent and scientific research:
Determine intellectual property landscape surrounding the project Better understand the general and specific application Determine historical trends Determine current state of the art
What does ANSI Y.14.5 (Now renamed to ASME Y14.5) relate to?
Dimensioning and tolerancing
Describe Design and Development planning:
Direct activities/identify factors in generation of a design/development plan Flexibility build in to determine which parts of the plan are necessary for each project
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?
Drugs achieve their effect through chemical action and is dependent upon being metabolized
What is design validation?
Ensuring that the developed medical device confirms to user needs and intended uses
What branch of government is the FDA in?
Executive
Fill in the blank: _____ 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
T/F: 510k submissions never require any data collected in clinical investigations.
False
T/F: A needs statement should have a conceptual solution embedded into it.
False
T/F: All class I devices exempt from special controls that apply to class II and class III devices.
False
T/F: Class III devices are never eligible for 510k clearance.
False
T/F: Grounding is not required for Class I equipment.
False
T/F: It is okay for a requirement to be vague, ambiguous, or conflicting.
False
T/F: Patients are autmatically enforced by the USPTO.
False
T/F: Planning is not mandated by 21 CFR 820.30, but it will help you complete the project on time, within the budget, and using the allocated resources.
False
T/F: Reproducibility and precision imply accuracy
False
T/F: Software cannot be considered a medical device.
False
Understand the FDA design control principles
Five reasons for design control: It is systematic Create process to meet needs It is team based Can bring in multidisciplinary teams Customer Focused Requirements play a key role in driving specifications and validations Robust Verification and validation ensure a higher quality design Required by law Yea, it is
How do you define a medical device?
Food Drug and Cosmetic Act (1938) section 201(h): ... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Design review?
Formal review are documented. Bring in one person who is not a part of the design process. To validate the relevant stages of the project.
Describe what Special Controls are:
Generally for Class II or III devices Assume that General Controls are not sufficient to ensure the safety and effectiveness of the device Varies by product. May include: Special labeling requirements Conformance with certain FDA guidelines Mandatory performance standards Human clinical trials Post market surveillance
What is a design master record?
Given to manufacturing/quality assurance Finished design output (device, packaging/labeling, prototyping/results)
Describe Design verification:
Guarantee that device specifications are met Partial evaluation of safety and effectiveness Methods for evaluation
Which of the following ISO standards applies to risk management?
ISO 14971
A device is considered substantially equivalent if it: (2)
If it has the same intended use as the predicate and the same technological characteristics If it has the same intended use as the predicate, but different technological characteristics, the information submitted to the FDA does not raise new questions about safety and efficacy, and it demonstrates the device is at least as safe and effective as the legally marketed device
The objectives of a design review include:
Include individual(s) who does not have direct responsibility for the design stage being reviewed Evaluate the return on investment (ROI) Evaluate the adequacy of the design requirements Confirm and assure that the device is safe and effective
What is design?
It is NOT research or craftsmanship! Involves devices, processes, re-engineering, systems, optimization, regulations, finances, innovation, invention, entrepreneurship, etc. Product refers to hardware, service or mission Process refers to the means by which a product is manufactured and supported Development refers to the refinement of products and processes to correct problems
Which of the following statements is true?
Leakage currents are measured during both normal and single fault conditions
What 3 requirements are considered to be the minimal requirements for general controls?
Manufacturing per cGMP Manufacturing registration Device labeling
Fill in the blank: A specification consists of a _______ and a _______ .
Metric; Value
What is an example of a need?
Need Statement Example: Patients need more effective pain relief.
How do needs funnel into requirements?
Needs are broadly stated Requirements should be well defined and (are often) measurable Specifications provide the detail (a metric and value)
Electrical safety must be tested:
On newly acquired equipment prior to being accepted for use After repairs have been carried out on equipment During routine planned preventative maintenance
At what point during the medical device design process must risk management take place?
Ongoing during the entire process
What parts of a project are ongoing activities?
Planning and Risk Analysis are always on going throughout the design process, and are updated as needed.
What is an example of a problem?
Problem Example: Patients after gallbladder removal surgery were in pain
Design verification?
Procedures for verifying device design Confirm output = input Documented
Design Validation?
Production units - usually 3 consecutive production lots Defined operating conditions Ensure devices conform to user needs and intended uses Documented
Why do medical devices fail and therefore impose risk on the user?
Quality assurance deficiencies Misuse Design deficiencies
What's the purpose for conducting a risk analysis?
Reduce probability of having a recall Required in PMA and 510(k) filings Required by law Reduce product liability and damage awards
The multifaceted nature of medical device design
Represent different company departments management/financial Marketing Regulatory Manufacturing and Quality Assurance R&D (Engineering Design Team) Team lead and team members (electrical, mechanical, materials, computational, etc.)
What is the significance of a traceability matrix in medical device design?
Required by the FDA Basic design control tool used to establish clear linkages between design inputs, outputs, verifications, validations and risk analyses
Fill in the blank: Product design specification must be specific in translating and interpreting __________ into engineering, quantifiable terms.
Requirements
Fill in the blank: Risk index = _________ index x _________ index
Severity Index x Likelihood Index
All of the following are characteristic of a patent drawing:
Shading, Scale, Black & White, Variety of views, Number, Letters and Reference Characters
Broadly acceptable level of risk determination is driven by:
Societal values
Describe major milestone:
Team meets with other to review if project plan and proposed design is meeting requirements
What are the 5 centers in the FDA?
The Center for Drug Evaluation and Research (CDER) The Center for Biologics Evaluation and Research (CBER) The Center for Devices and Radiological Health (CDRH) The Center for Food Safety and Applied Nutrition (CFSAN) The Center for Veterinary Medicine (CVM)
What branch of the US government is responsible for the regulation of medical devices?
The Department of Health and Human Services
List and describe any subsequent legislation.
The Medical Device Amendments, 1976 Safety and effectiveness of medical devices Manufacturer registration Develop processes for premarket notifications, approvals, predicate devices, and performance standards Safe Medical Devices Act (SMDA), 1990 Requires hospitals to report incidents involving medical devices that are reasonably believed to have caused or contributed to the serious injury or death of a patient or employee Requires manufacturers to conduct post-market surveillance of implanted devices Food and Drug Admin. Modernization Act (FDAMA), 1997 Increased efficiency of reviews, harmonized FDA and other regulatory standards, QSR Medical Device Fee and Modernization Act, 2002 Allows FDA to collect fees to review medical device submissions
If you desire to know what is actually covered by a granted patent, what should you look at?
The claims
Leakage current is:
The current that passes through the patient's body in the course of device operation The current that passed through the caregiver's body in the course of device operation
The phrase "the voice of the customer" refers to what aspect of design and development?
The development of user needs
Electrical shock may result from:
The following 3 conditions must occur simultaneously A voltage source driving current through the body between those two points of contacts One part of the body being in contact with a conductive surface A different part of the same body being in contact with a second conductive surface
What language should the user needs be written in?
The language of the user.
What key factors contribute to something being classified differently?
The location and the duration of the devices use.
Devices are regulated by the FDA according to the:
The risks posed by their use
A design project does not have to contain what (1)? What do they have to contain (3)?
They do not have to contain Gantt charts, but they do contain: Subprojects, tasks, and milestones A signature block for responsible parties An assignment of responsibilities
Before deciding on a project and developing design requirements, the team define what 2 items?
They must define the problem They must define the need
What should be involved in a NEED statement?
Translation of clinical problems into need statements Need statement shouldn't be too broad or too narrow Need statement addresses the question DO NOT EMBED SOLUTION INTO NEED STATEMENT Include a "user" - who "needs" to have the problem solved Include a metric - a way to determine whether the solution meets the need (when it's completed) Remember, WHAT not HOW
T/F: A need statement should have a quantifiable metric associated with it.
True
T/F: Accuracy is a measure of the total error.
True
T/F: After the patent terms expire, the invention becomes "public domain" and may be made, used, or sold by anyone without licensing.
True
T/F: All medical devices are subject to general controls.
True
T/F: Class II electrical instruments use "live" and "neutral" connections only.
True
T/F: Requirements are often measurable
True
Design History File organization:
Use subsections for document flow. Input requirements SOP for an example Required to contain the following: Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) Technical documentation File (TDF) Typically contains: Executive summaries Research bibliographies Marketing requirement document Design specification document Others (design output, testing, etc.)
Describe what General Controls are:
Used for all medical devices Considered to be the minimum requirements Manufacturing registration Label devices per regulations Submit a premarket notification [510(k)], unless exempt Manufacture devices per cGMP regulations (Current Good Manufacturing Practice)
A design review is an examination of a design or process that is:
Used to bring a cross-functional team to the table to ensure the design team has not missed something overall Documented An ongoing part of the entire design process
Put the following components of the design process in order:
User needs in user terms Marketing requirements are measurable Specifications provide the details to build Prototype is built to specifications Verification testing ensures prototype (specifications) meets requirements
What are (3) types of patents? What are (2) that are not?
Utility patent, design patent, and plant patent are considered types of patents. Whereas a copyright patent and a trade secret patent are not considered types of patents.
Understand the BIO EN 3801 DC SOPs (6)
What is the purpose of the document? Lay out the design and development plan. What is the scope of the document/project? Responsibility - who is in charge? How are revisions made? How are things approved? Include definitions, references, applicable documents, and history. Safety considerations Procedures or policy(s)
