based upon the review of assigned fda guidance write a short analysis paper

PART I: A manufacturer is developing a device which is a bone graft product, and indicated only for bony voids or gaps that are not intrinsic to the stability of the bone structure. The therapeutic aspect of this product would be treating the surgically created osseous defects or osseous defects created from traumatic injury to the bone, and will be used as graft syringe. Identify this subject product from the FDA database, and write a summary including 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 justify its intended purpose. o Include all information per the product identification template provided. Part II – ANALYSIS The 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 a benchmark, write an analysis about challenges in developing such products, and their requirements to maintain safety and efficacy. Also consider if this guidance applies to subject product described above and/ or if the guidance meets the requirement for all products within this category in alignment to the current regulatory environment. After identifying the referenced subject product, and based upon the review of assigned FDA Guidance, write a short “ANALYSIS PAPER” including the following: 2 | P a g e o What could be a regulatory challenge with this product, and how the regulatory guidance 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 regulating such products and their future scope. Include any other criterion per your research on the topic. NOTE: THE PAPER SHOULD BE WRITTEN AS AN DESCRIPTIVE COMPREHENSIVE ANALYSIS (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 the topic should be properly cited as a reference. The assignment must include proper citation practices (AMA or APA style). o Do not copy direct text from the citations, rather research, analyze and write in your own words.

O Note: This is a graded assignment, and applicable to Individual grade points. Refer to the 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 FORM THE 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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