Florida health care attorney, Medicare compliance & suspension, AHCA licensing, Florida Board of Medicine, and Florida Medicaid overpayments. FDA attorney attorney for drug, cosmetics and medical devices including software as a Medical Device (SaMD), and digital therapeutics.

Phone: 786.440.8115

Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.

Monthly Archives: September 2013

26 Sep

FDA to begin regulating mobile medical applications

The FDA has issued Mobile Medical Applications Final Guidance regarding the monitoring of Smartphone software applications with medical applications as a “medical device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Consistent with FDA’s existing regulatory approach that considers functionality rather than platform, the FDA intends to exercise its jurisdiction over those mobile

24 Sep

Ann Marie Gaitan offers FREE webinar on medical device regulation

Due to the overwhelming positive response after Mrs. Gaitan’s speaking engagement at the FIME International Medical Exposition on “How FDA Regulates Non-Compliant Medical Devices Not Intended for U.S. Consumers”, Mrs. Gaitan will be presenting a webinar on basic FDA requirements for medical devices on Monday, September 30th, 2013. “Introduction to FDA Medical Device Regulatory Requirements”