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.

M4A1 Case Study ScenarioSCENARIO: Mr. G. is a resident at the Excelsior Assisted Living Center.. He has lived here for the past three years in a single studio unit. His wife passed away 4 years ago. He is 83 years old. He is friendly and active in recreational activities in the facility and in the community. In addition, he sees his son and grandchildren every other week.Members of Mr. G’s Excelsior care team:•Assisted Living Administrator–Ms. Miller•Resident (Mr. G.)•Floor Supervisor (you)•Nurse Manager•Recreation Therapist.–Greg, CTRS•Dietitian•Social Worker•Resident’s adult son –TedYou are a Floor Supervisor at Excelsior Assisted Living Facility and are assigned to the floor where Mr. G. resides. Greg, the Recreation Therapist, comes to talk to you about Mr. G. Greg has built a close relationship with Mr. G. He explains that Mr. G. appears unkempt, and sometimes smells of urine. Other residents have started to make remarks about Mr. G’s odor and staff is complaining as well. You review the situation by having a discussion with Mr. G. and several discussions with other staff on the floor.It becomes clear to you that Mr. G. needs more personal hygiene care than he can provide for himself or that the facility can provide. You present this information to the administrator, Ms. Miller.Ms. Miller contacts Mr. G’s son, Ted, and explains the situation. She offers the son the option to pay for extra services from the facility or to hire an external Personal Care Assistant.(PCA). She explains thatit may be more cost effective to hire someone from an outside agency. He asks for a recommendation and Ms. Miller provides a list, highlighting an agency that the facility has worked with in the past. Ted contacts the agency and Gloria is hired as a PCA. Gloria begins visiting three times per week.(Two months later) cut to your office!Greg comes to your office. Over a cup of coffee, he explains that while Mr. G’s hygiene has significantly improved he has new concerns he wants to run by you. He and Mr. G. were at the mall buying a birthday gift for one of the grandchildren. Mr. G. was expressing anger and confusion about the medications his doctor is prescribing.As the conversation progressed Mr. G. confided the following to Greg. He is thinking of stopping his statin medication under the advice of his PCA, Gloria. Gloria was asking him about side effects from his medications. Mr. G. thinks that he has been experiencing some of these side effects and wonders if his lack of bladder control might be from his medications. He acknowledges feeling deeply embarrassed by having to wear adult“diapers.” Mr. G. told him that Gloria was also showing him news articles regarding potential dangers of taking statins long term.Cut to Ms. Miller’s officeYou and Greg ask to meet with Ms. Miller. You express your concerns about Gloria overstepping her role and the potential medical risks for Mr. G who has a significant history of cardiac disease. At the same time, you don’t want to impinge on the working relationship he has with Gloria as he is very fond of her and has improved since her hiring.Your charge: Ms. Miller decides to call a meeting of Mr. G’s entire care team (see team listed above). She asks you to prepare an SBAR for the meeting.