based upon the review of assigned FDA Guidance, write a short ANALYSIS PAPER
Question Description
PART I:A manufacturer is developing a device which is a bone graft product, and indicated only forbony voids or gaps that are not intrinsic to the stability of the bone structure. Thetherapeutic aspect of this product would be treating the surgically created osseous defectsor osseous defects created from traumatic injury to the bone, and will be used as graftsyringe. Identify this subject product from the FDA database, and write a summaryincluding the following:
o Type of product.o Classification type.o Regulatory submission type.o Medical Specialty, Product Classification Code.o Shelf-life of the product.o Regulatory pathway for market (Priority, Standard., etc.)o Any other specifics to be included in labeling.o Any special standards that would need to develop design for this product to justifyits intended purpose.o Include all information per the product identification template provided.Part II – ANALYSISThe US FDA issued a Guidance for Industry – Class II Special Controls Guidance Document:Resorbable Calcium Salt Bone Void Filler Device. Using this guidance document as abenchmark, write an analysis about challenges in developing such products, and theirrequirements to maintain safety and efficacy. Also consider if this guidance applies tosubject product described above and/ or if the guidance meets the requirement for allproducts within this category in alignment to the current regulatory environment. Afteridentifying the referenced subject product, and based upon the review of assigned FDAGuidance, write a short “ANALYSIS PAPER” including the following:2 | P a g eo What could be a regulatory challenge with this product, and how the regulatoryguidance is applicable to the regulation of this product?o What could be the safety issues (bone void filler type product)?o Based upon the analysis, add any regulatory issue?o Per your analysis on this topic, conclude the paper with your outlook for regulatingsuch products and their future scope. Include any other criterion per your researchon the topic.NOTE: THE PAPER SHOULD BE WRITTEN AS AN DESCRIPTIVE COMPREHENSIVEANALYSIS (NO BULLET POINTS).INSTRUCTIONS FOR THE WRITTEN ASSIGNMENT:o This assignment is an individual write-up, and must be completed individually (i.e.,no group discussion is required)o Assignment must be submitted using TURNITIN link on blackboard.o The assignment can include relevant citations. The web resources reviewed on thetopic should be properly cited as a reference. The assignment must include propercitation practices (AMA or APA style).o Do not copy direct text from the citations, rather research, analyze and write in yourown words.
O Note: This is a graded assignment, and applicable to Individual grade points. Refer tothe course syllabus for detailed grade point distribution for assignments.PAGE LIMIT:1. PRODUCT STUDY – 2 PAGE WRITE-UP.2. ANALYSIS – SUBMIT 2 PAGE WRITE-UP.TOTAL = 4 PAGES ALLOWED.THE TITLE PAGE AND CITATIONS CAN BE INCLUDED SEPARATE FORMTHE PAGE COUNT.FONT: TIMES NEW ROMAN (12 SIZE, SINGLE-LINE SPACING)
And the device should be within the past 4 years.
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