X-Frame-Options: SAMEORIGIN
: 516-482-9001

Tag Archives: FDA regulation

28 Oct

FDA Update: Hearing Aid – OTC

Hearing Aid – OTC For those with mild to moderate hearing loss the day may be close when hearing aids are available over the counter… The FDA Issues Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products Hearing loss affects an estimated

12 Nov

Medicare’s Regulations Regarding Coverage

The FDA’s regulations state that isolated case reports, random experience, reports lacking enough detail to permit scientific evaluation, and unsubstantiated opinions do not constitute valid scientific evidence. More device manufacturers are recognizing the importance of considering Medicare coverage and reimbursement principles during the development of their new technologies. By adopting long- and short-term strategies that

Archives