Heed wk 3 | Business & Finance homework help

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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?

1. The Approval Pathway is Based on Device Risk. Fill in the following table:
2. Explain the following:
3. What do you think is meant by “least burdensome” on slide 6, and why is this important (refer to slides 12-13)?
4. Define Predicate (slide 6):
5. Define DeNovo (slide 6):
6. What is a Pre-Sub, and why is this beneficial for companies?
7. 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.
8. Explain Substantial Equivalence

image1.png Version 6 Homework Assignment 3 Pathway for Patient Health Global Regulatory and Legal Requirements of Quality

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.

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

Rubric:

Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health [email protected] | 513-238-4338 | www.Pathway4PH.org