Job Description
b. Overview: Research FDA regulations surrounding neurofeedback training in the USA
c. Reason for position: Our company is on the verge of massive expansion. Our product’s concept is proven and we are ready to bring our product to the consumer market. The number of individuals that we train will rise from in the 100’s to in the 100,000’s. We plan to sell in the USA and are looking to clarify the laws governing our niche product’s sale and use in commercial markets. We will not be able to sell our product in the US without knowing this information: this is very important work.
d. Objectives:
i. Present regulations governing EEG machine use and sale in the USA.
ii. Present regulations governing neurofeedback training in the USA, for medical treatment purposes (ADHD, depression, etc.) and non-medical purposes (meditation, etc.).
iii. Present regulations governing performance improvement technology and sports technology in the USA.
iv. Present the steps required in the following processes: a) Approving our product for the American medical market (rehabilitation) b) Approving our product for the American non-medical market (performance improvement) c) Approving our specific hardware, manufactured in Russia, for use in the USA.
e. Phases of Work (all phases are supervised closely):
i. Design Project Plan (with approval of company)
ii. Gather Legal Information & Review
iii. Write Report
iv. Report Revisions, Further Direction
v. Final Presentation
Benefits
Qualifications
Legal student (future, present or past)