re: Should Mobile Medical Apps Require FDA Approval?
"The new FDA guidelines may create headaches for developers, but there is an upside for doctors and patients. "
Registrar Corp's team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:
Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed at no extra cost.
Assistance determining if U.S. FDA Medical Device User Fees are required for your registration and, if so, help prepare and submit your payment per U.S. FDA's requirements.
Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.