Biomedical Diagnostic Product

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This project requires that you identify and describe a cutting edge biomedical diagnostic product or service — you may want to choose something that has recently been marketed, is in development or imagine a near-future product/service.
Your team are regulatory affairs consultants and your task is to give the company developing this new product or service advice about the regulatory environment it will be entering. What are the regulatory issues that the company will face in developing, commercializing and marketing their product?

Each paper should include information about the following:
Product/Service context:
Explain the technology to the best of your ability, how does it function, what will it be used to do (claim)
What is the need for this product?
Tell us who the developer is (can be a fictitious or real company/organization) and who will be performing the tests?
Is this an entirely new product or service or is it similar to something already on the market?
FDA market access regulation
Is the FDA going to regulate this product or service?
Is the technology an in vitro diagnostic, a laboratory based test, a companion diagnostic, an over the counter or direct to consumer product?
If it is subject to FDA regulation, what sort of risk will the device pose? What risk classification would you propose it fall under?
CLIA regulation
Who will be performing this assay or using this diagnostic product?
Does the lab or company that will be using the product/service need to comply with CLIA regulations? Why or why not?
If yes, what sort of CLIA certification will be needed to offer the diagnostic?
Miscellaneous Regulations — as relevant please discuss:
Clinical trials:
Does the company need to develop evidence about the product’s safety & efficacy?
Will the manufacturer/developer conduct clinical trials?
Will clinical trial protocols need to be reviewed by an IRB?
Is there any need for the company to apply for an Investigational Device Exemption, a Research Use Only or Investigational Use Only of the diagnostic/device. Explain why?
Privacy: Does the assay or device pose any particular data privacy issues?
Manufacturing:
Is the device being manufactured?
Are there any particular manufacturing regulations or post marketing regulations that it should comply with?
Pricing, Reimbursement, and Post-Market Issues
Who is this product intended for (e.g. specific types of patients, pharmaceutical firms or researchers, general public)?
What is the approximate size of the market for this product?
What can the manufacturer/developer need to do to demonstrate the test’s value?
To whom do you think the manufacturer/developer need to demonstrate clinical utility? CMS, insurance companies, hospitals?
Do you have any sense of what price this product or service will be able to ask on the market? At what approximate level will it be priced or reimbursed?
Conclusions
What is the main regulatory challenge it needs to overcome to get this product to market and profitable?
Do you advise the company to continue the development of this product? Why or why not?
References
References can be cited using any common citation style (eg, APA or AMA)
Tutorials can be found online (https://lib.asu.edu/tutorials (Links to an external site.))
(Please make sure that you cite the sources that you used in researching your sections, especially when using another author’s data)

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