Heed wk 3
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Heedwk3assign.docx
- 15_grlr_part_1_validation_overview_v3.pdf
study_guide_17a_pathway_to_medical_device_approval_slides_1_15_grlr_v1.docx
Global Regulatory and Legal Requirements of Quality.v1
17a Study Guide- Pathway to Medical Device Approval Part 1
1. Which branch of FDA Approves Medical Device products?
2. The Approval Pathway is Based on Device Risk. Fill in the following table:
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Medical Device Risk Classification |
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Classification |
Define |
Examples |
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Class I |
|
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Class II |
|
|
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Class III |
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3. Explain the following:
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FDA Submission Types |
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PMA |
510(k) |
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4. What do you think is meant by “least burdensome” on slide 6, and why is this important (refer to slides 12-13)?
5. Define Predicate (slide 6):
6. Define DeNovo (slide 6):
7. What is a Pre-Sub, and why is this beneficial for companies?
8. On slide 11, a 510(k) is to request ________________ for your product to be on the market, whereas a Pre-Market Approval application is to request approval.
9. Explain Substantial Equivalence
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Heedwk3assign.docx
Version 6
Homework Assignment 3
Pathway for Patient Health
Global Regulatory and Legal Requirements of Quality
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Complete this assignment by typing your answers into this Word document |
First Name:
Last Name:
Email address:
· Save this file as: First Name Last Name GRLR Project 3 (e.g. Marla Phillips GRLR Project 3.doc)
· Submit this assignment in Canvas
· Assignment due dates are as listed in the syllabus.
· Generative AI use is not allowed on this assignment.
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This assignment must be submitted by the due date that was provided to you by 11:59pm (EST) |
Review the FDA Guidance on Cleaning Validation, and describe:
1. What series of events (plural) caused the FDA to focus on how equipment is cleaned, and when did that occur? (Note: this is described in the FDA guidance document)
2. Describe what can be tested in order to determine if the equipment is clean. (Note: what would you test and give a short narrative description on why)
3. Describe 2 examples of why it is critical to document the cleaning process.
4. What types of contamination can be present in the equipment? (list 3 types)
5. An entrapment area (a.k.a. dead-legs) in equipment is a place where part of the product/formulation can become trapped/lodged in the equipment (for example, where two parts of the equipment are joined together, where there is curvature in the equipment, etc.), and is challenging to flush, rinse or wipe clean. The entrapped product/formulation can become dislodged during the production of another product and cause cross-contamination. How could you reduce the risk of entrapment?
( Hint: See the assignment rubric below to ensure that you are providing a complete answer.)
Resource you will need for this Assignment:
· Lecture notes
· Review the FDA Guidance on Cleaning Validation. Access Cleaning Validation Document
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Grading Comments for Question 1 |
Score for Question 1 (Possible 2) |
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Grading Comments for Question 2 |
Score for Question 2 (Possible 2) |
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Grading Comments for Question 3 |
Score for Question 1 (Possible 2) |
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Grading Comments for Question 4 |
Score for Question 2 (Possible 2) |
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Grading Comments for Question 5 |
Score for Question 1 (Possible 2) |
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Rubric:
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Does not meet requirements |
Excellent |
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Question 1
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No engagement/effort with this question. (0) Use of AI (0) |
The student identified a logical series of events that led to the focus on cleaning validation. (1-2) |
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Question 2 |
No engagement/effort with this question. (0) Use of AI (0) |
The student identified at least one example of what can be tested (1-2) |
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Question 3 |
No engagement/effort with this question. (0) Use of AI (0) |
The student explained why it is critical to document the cleaning process. (1-2) |
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Question 4 |
No engagement/effort with this question. (0) Use of AI (0) |
The student lists 3 types of contamination. (1-2) |
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Question 5 |
No engagement/effort with this question. (0) Use of AI (0) |
The student explained how to reduce the risk of entrapment. (1-2) |
Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health
[email protected] | 513-238-4338 | www.Pathway4PH.org
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study_guide_17a_pathway_to_medical_device_approval_slides_1_15_grlr_v1.docx
Global Regulatory and Legal Requirements of Quality.v1
17a Study Guide- Pathway to Medical Device Approval Part 1
1. Which branch of FDA Approves Medical Device products?
2. The Approval Pathway is Based on Device Risk. Fill in the following table:
|
Medical Device Risk Classification |
||
|
Classification |
Define |
Examples |
|
Class I |
|
|
|
Class II |
|
|
|
Class III |
|
|
3. Explain the following:
|
FDA Submission Types |
|
|
PMA |
510(k) |
|
|
|
4. What do you think is meant by “least burdensome” on slide 6, and why is this important (refer to slides 12-13)?
5. Define Predicate (slide 6):
6. Define DeNovo (slide 6):
7. What is a Pre-Sub, and why is this beneficial for companies?
8. On slide 11, a 510(k) is to request ________________ for your product to be on the market, whereas a Pre-Market Approval application is to request approval.
9. Explain Substantial Equivalence
