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
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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”
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Ann 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,
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Earlier today, the U.S. Food and Drug Administration (FDA) announced the publication of two proposed rules, as part of the implementation of the Food Safety Modernization Act (FSMA). The proposed rules address the “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (FSVP) and ” Accreditation of Third-party Auditors”, aimed at ensuring
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The U.S. Food and Drug Administration (FDA) announced today that it “is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.” The FDA’s announcement comes just days after the agency issued Warning Letters to 15 foreign and
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