CASE DESCRIPTION:
Assessment 1: Regulatory Strategy & Submission
A manufacturer is developing an absorbable hemostatic agent. The product is indicated in surgical
procedures, and could serve as an aide to hemostasis, to control mild or moderate bleeding symptoms.
The product should not be used in tissue, or vessels (including clamped, or bypassed); closure of skin
incisions; in absence of active blood flow; and for the treatment of severe or extreme bleeding. The risk
factors include allergic- anaphylactoid reaction and/or thromboembolic events; hypersensitivity to
materials of porcine or bovine origin.
As a team project prepare a regulatory strategy demonstrating how to introduce a device to the commercial
market by selecting an appropriate regulatory path. Consider that your team is hired as a consulting firm
and prepare a regulatory strategy with appropriate submission type, comprehensive details for submission
(all levels of product development), and recommendations for market approvals for release.
Review the US FDA PMA database for identifying the subject product based upon the product description
[Yr. 2017-2019]. This is a team project, and all team members must participate in class presentation, and
paper preparation.
Include all elements of an applicable submission including the following criteria, though not
limited to, the following:
1. Determine the device classification
2. Identification (Definition of the type of device)
3. Applicable Product code
4. Identify the Subject device and its category (i.e. type of device)
5. Predicate device (if any)
6. Medical Specialty
7. Advisory Panel
8. Device type (Combination, Implanted Device or Medical device) – As applicable.
9. Identify applicable CFRs.
10. Write a full regulatory pathway for an appropriate regulatory submission and best route for
clearance or approval for market. Consider the FDA’s guidance of least burdensome approach.
11. What type or category approval can be expected for this product?
12. Any conditions on device approval?
13. What could be the potential clinical trials plan (population, grouping, inclusions/exclusions, and
related information)? What could be the type of endpoints to determine the safety and
effectiveness?
14. What type of stability data and packaging applicable for the device shelf life proposal?
15. Add information for the post market compliance requirements.
16. Any other additional information.
Note – for Assessment 2 and 3 section below, apply the compliance strategy that would apply to
the product in the current FDA regulated environment.
Assessment 2: Create Draft Labeling
Include in this assignment paper full labeling overview.
a) Based upon the type of product and therapeutic indication (disease condition), create a DRAFT
proposed label, inclusive of indication and contraindications, with comprehensive risk/benefits and
safety (warnings/precautions) criterion summary.
b) Assess all possible types of therapeutic conditions which can be treated with the subject device.
c) Based upon your assessment of Contraindications – draft the applicable contraindications for this
product, including the reason why these could attribute towards or could lead to serious adverse
events, or health complications.
d) Include an Appendix with full safety and effectiveness summary description based upon the
research on the identified subject device, including a comparison with at least ONE most recent
product approved through the similar regulatory path in the US market.
e) Add the most effective clinical end points criterion applicable to the product.
f) Create a risk profile by assessing the requirements for a regulated product such as the identified
subject device. Add a comprehensive outline of the risk assessment to the paper.
Assessment 2, Appendix page limit 3-5 pages.
Assessment 3: Post-market PMA Supplement.
The manufacturer is expected to apply post-market phase changes to the product. Assess the following and
prepare an appropriate post-market supplement rationale inclusive of PMA type category and high-level
overview of rationale to be included in submission.
1) Modified design/components including material change.
2) Change in the controls of the manufacturing environment.
Assessment 3, Appendix page limit 1-2 pages.
IN CLASS PRESENTATION: 15-18 SLIDES (15 MINS., ALLOWED)
PAPER PAGE LIMIT: 20 PAGES, AND ASSESSMENT WITH APPLICABLE
APPENDICES. FONT: TIMES NEW ROMAN (12 SIZE, DOUBLE-LINE SPACING)
INSTRUCTIONS FOR THE WRITTEN ASSIGNMENT:
o REQUIRED: The assignment must include relevant citations. The web resources reviewed on
the topic should be properly cited as a reference. The assignment must include proper citation
practices (AMA style
Did you know that effective analysis of concepts requires professionalism in handling academic research Papers? Do no compromise on your grade choose professional Research writers at elitetutorslab.com