Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
FDA’s 510(k) Third-Party Review program benefits the public health by allowing low-to-moderate risk medical devices obtain FDA-equivalent review while enabling FDA to focus more resources on higher risk and more complex devices.
Read MoreOn May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM) devices (aka 3D printed medical devices), the category of manufacturing that includes 3-dimensional (3D) printing. The FDA described this as a “leapfrog” guidance through
Read MoreToday the FDA posted draft guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). When finalized, this guidance will provide information on: FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices The special considerations that apply
Read MoreElva Navarro, of Hidalgo,Texas, has been sentenced to three years in federal prison to be immediately followed by one year of supervised release for violating the U.S. Food, Drug and Cosmetics Act by using an adulterated device. Court documents demonstrated that Navarro administered injections of liquid silicone into individuals who would frequent her facility – Bella
Read MoreThe 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
Read MoreDue 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”
Read MoreAnn Marie Gaitan will be presenting “Import for Export: How FDA Regulates Non-Compliant Medical Devices Not Intended for U.S. Consumers” at FIME International Medical Exposition, on August 8 at 2:00 PM, at the Miami Beach Convention Center. Mrs. Gaitan, leads the firm’s FDA Compliance practice group. She represents medical device companies from across the globe,
Read MoreManufacturers often make changes or modifications to a device after FDA clearance such as incorporating new technology or upgrading certain aspects of the device. Many changes do not require a 510(k) submission. But when the changes could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.
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