Northeaster University Global Health Paper

Review the FDA Guidance for Industry – Polymethylmethacrylate (PMMA) Bone Cement – Class II Special
Controls Guidance Document for Industry and FDA. Using this guidance document as a benchmark, write
an analysis about challenges in developing such product types (i.e., refer to guidance), and their
requirements to maintain safety and efficacy applicable to therapeutic use.

After identifying the referenced subject product, and based upon the review of assigned FDA
Guidance, write an “ANALYSIS PAPER” including the following:
• Write a summary about the identified subject product.
• Explain what type of safety issues could apply towards the use of the subject product. Add
any regulatory issue?
• Per your analysis on this topic, conclude the paper with your outlook for regulating the product
types applicable to the guidance, and their future scope. Include any other criterion per your
research on the topic.
• Add any research based new information about current market trends.
• Add yourrecommendation in terms of how regulation should be developed for future
innovative products in this category.
• Add any other information that would support your analysis.