Biomedical Engineering Design Quiz

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Questions and Answers

What is the primary focus of biomedical engineering design?

Developing software and applications for medical facilities.

Integrating artistic design into healthcare technology.

Using a systematic approach to develop medical devices. (correct)

Applying principles of biology to improve patient care.

According to WHO, what is the critical factor that determines if a product is a medical device?

The product's complexity.

The product's intended medical purpose. (correct)

Whether the product is used in a hospital setting.

If the product is innovative and new.

Which aspect is NOT explicitly mentioned as a key element in biomedical engineering design?

Use of medical knowledge

Application of engineering principles

Focus on cost-effectiveness (correct)

Use of Biological knowledge

What range of products can be classified as a medical device, according to the context?

Both simple and complex instruments, software, and materials. Signup and view all the answers

What is the role of creativity in biomedical engineering design?

It is used to develop novel solutions. Signup and view all the answers

According to section 520(o)(1)(B) of the FD&C Act, which of the following is NOT considered a medical device?

Fitness trackers that encourage a healthy lifestyle. Signup and view all the answers

What is the primary factor determining the classification of a medical device?

The level of risk associated with the device's use. Signup and view all the answers

Which class of medical devices involves the lowest risk to the user?

Class I Signup and view all the answers

A medical device that does NOT help support life, nor is important in preventing impairement of human health would be classified as:

A Class I device. Signup and view all the answers

Which of these is an example of a Class I medical device?

Surgical masks. Signup and view all the answers

What type of controls are required for Class I medical devices?

General Controls, some may require a 510(k). Signup and view all the answers

According the document available, what is the correct way to find medical device classifications?

Google 'accessdata.fda.gov' Signup and view all the answers

Which medical device class requires both general controls and pre-market approval (PMA)?

Class III Signup and view all the answers

True or False: According to the text, all class I medical devices require 510(k) premarket notification.

False Signup and view all the answers

Which of the following is NOT an example of a Class II medical device?

Pacemakers Signup and view all the answers

Under which classification can a new medical device that does not pose a significant risk be placed?

Class I or II Signup and view all the answers

Which of the following is a general control applicable to medical devices?

Good Manufacturing Practices Signup and view all the answers

Which of these controls is specific to devices requiring Pre-Market Approval (PMA)?

Bench testing Signup and view all the answers

What was the original placement for a new medical device not already in the FDA database, according to the Medical Device Regulation Act of 1976?

Class III Signup and view all the answers

Which of the following factors differentiate Class II devices from class I devices?

Class II devices require special controls. Signup and view all the answers

What is the primary purpose of the De-Novo classification pathway?

To allow low-risk new devices to be placed in Class I or II. Signup and view all the answers

According to the FDA definition, which of these is a primary characteristic of a medical device?

It is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Signup and view all the answers

What is a crucial first step in determining if a product is classified as a medical device?

Determining the intended use of the product. Signup and view all the answers

Which of the following best represents the described use for personal protective equipment, according to the examples?

Protecting against the spread of microorganisms in adults. Signup and view all the answers

What is a key difference between a medical device and a pharmaceutical product, according to the text?

Medical devices achieve their purpose without chemical action, whereas pharmaceuticals might act through chemical action. Signup and view all the answers

Which of the following best describes how to define the intended use of a product?

By stating the general purpose, the disease or condition addressed, and the intended patient/user population. Signup and view all the answers

If a product increases mobility for an outpatient after a leg amputation, what is its general purpose, as stated in the example?

Increasing mobility of users Signup and view all the answers

Which characteristic, if present, would automatically exclude a product from being classified as a medical device, according to the text?

Achieving its primary purpose through chemical action within the body. Signup and view all the answers

Where would you look to find if a product is officially recognized as a medical device component?

The official National Formulary or the United States Pharmacopoeia. Signup and view all the answers

Study Notes

Biomedical Engineering Design I - BME 251

The BME design process includes: Design Team Development & Planning, Project Statement, Specification, Solution Concepts & Selection, Detailed Design & Prototype, Validation and Verification Testing, Standards, Regulation & Ethics, Commercialization & Post-Market Surveillance.
The lecture was delivered by Dr. Daniel Akwei Addo.
The course covered Biomedical Engineering Design, Medical Device Determination, and Medical Device Classification.
One learning objective was identifying elements determining a product's qualification as a medical device.
Another learning objective was classifying medical devices.
A third learning objective was describing how the stage-gate model, engineering design process, and spiral model affect medical device design decisions.

What is Biomedical Engineering Design?

Biomedical engineers systematically develop solutions addressing healthcare challenges.
The process combines engineering principles, biological and medical knowledge, and creativity to design devices, systems, or processes improving patient care, diagnosis, and treatment.
In essence, the role of biomedical engineers is designing medical devices.

Is My Product a Medical Device?

A medical device is defined by the World Health Organization (WHO) as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or related article, intended by the manufacturer to be used for a medical purpose.
The U.S. Food and Drug Administration (FDA) defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or related article (including components) used in the diagnosis, cure, mitigation, treatment, or prevention of disease, or in the alteration of structure or any function of the human body, that doesn't rely on chemical action within or on the body for primary function.
Factors determining if a product is a medical device include the intended use, and function of the device.
Clearly describing the general purpose or function of the product,
Describing the disease condition, and whether the device will diagnose, cure, mitigate, treat or prevent a condition.
Identifying the intended patient population.

Special Considerations for Product Classification

In Vitro Diagnostics (IVDs): These include reagents, instruments, and systems for diagnosing diseases, such as home pregnancy tests and glucose test strips. These devices typically involve collecting, preparing, and examining specimens from the human body, either in a laboratory setting or at home.
Radiation Emitting Products: These are electronic products containing electronic circuitry that emit electronic radiation. The majority of radiation-emitting products are not considered medical devices, although some may qualify if used with medical applications and claims.
Mobile Medical Applications (SaMDs): Software intended for one or more medical purposes, such as viewing MRI images from a smartphone.
General Wellness Products: Products intended for general wellness use and present a very low risk to users. These generally do not perform functions categorized as medical in nature. Examples include fitness trackers and apps.

Medical Device Classification

Medical devices are classified based on risk.
The higher the risks, the higher the class.
Class I devices involve low risk. They require general controls, and most examples are 510(k) exempt.
Class II devices present a higher risk than Class I and require both general and special controls (510k).
Class III devices present the highest risk and require a pre-market approval (PMA) process.
General controls include provisions for adulteration, misbranding, device registration and listing, and banned devices.
Special controls (510k) have specific sections required for submission.

Medical Device Regulation, De Novo Classification

For medical devices not in the FDA database, the FDA classifies them under Class III.
The de novo classification, introduced in 1997, allows for new devices with low risk to be classified under class I or II.
The de novo classification process requires general and special controls.

### Medical Device Definition Questions.

Is the device intended to diagnose, cure, mitigate, treat or prevent disease?
Is it intended to affect human body structure or function?
Does it achieve its intended purpose through chemical action or metabolism?
Based on the answers to these, the product can be determined to be a medical device of a certain class.

Existing Product Classification.

To determine if an existing product classification exists, use resources like the FDA's product classification database accessed at: https://www.accessdata.fda.gov/

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Description

Test your knowledge on the principles of biomedical engineering design and regulatory classifications of medical devices. This quiz covers key elements such as risk levels, creativity's role, and FDA regulations. Challenge yourself and deepen your understanding of this vital field.