Health and Medical the Bone Treatments Analysis Paper

December 14, 2022

Health and Medical the Bone Treatments Analysis Paper

Order Number	636738393092
Type of Project	ESSAY
Writer Level	PHD VERIFIED
Format	APA
Academic Sources	10
Page Count	3-12 PAGES

Instructions/Descriptions

Health and Medical the Bone Treatments Analysis Paper

Health, Medical, Bone, Treatments ,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.

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Health and Medical the Bone Treatments Analysis Paper

RUBRIC

Excellent Quality

95-100%

Introduction

45-41 points

The context and relevance of the issue, as well as a clear description of the study aim, are presented. The history of searches is discussed.

Literature Support

91-84 points

The context and relevance of the issue, as well as a clear description of the study aim, are presented. The history of searches is discussed.

Methodology

58-53 points

With titles for each slide as well as bulleted sections to group relevant information as required, the content is well-organized. Excellent use of typeface, color, images, effects, and so on to improve readability and presenting content. The minimum length criterion of 10 slides/pages is reached.

Average Score

50-85%

40-38 points

More depth/information is required for the context and importance, otherwise the study detail will be unclear. There is no search history information supplied.

83-76 points

There is a review of important theoretical literature, however there is limited integration of research into problem-related ideas. The review is just partly focused and arranged. There is research that both supports and opposes. A summary of the material given is provided. The conclusion may or may not include a biblical integration.

52-49 points

The content is somewhat ordered, but there is no discernible organization. The use of typeface, color, graphics, effects, and so on may sometimes distract from the presenting substance. It is possible that the length criteria will not be reached.

Poor Quality

0-45%

37-1 points

The context and/or importance are lacking. There is no search history information supplied.

75-1 points

There has been an examination of relevant theoretical literature, but still no research concerning problem-related concepts has been synthesized. The review is just somewhat focused and organized. The provided overview of content does not include any supporting or opposing research. The conclusion has no scriptural references.

48-1 points

There is no logical or apparent organizational structure. There is no discernible logical sequence. The use of typeface, color, graphics, effects, and so on often detracts from the presenting substance. It is possible that the length criteria will not be reached.