Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
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”
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 MoreEarlier 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
Read MoreThe 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
Read MorePhoenix Cardiac Surgery, P.C., of Phoenix and Prescott, Arizona, has agreed to pay the U.S. Department of Health and Human Services (HHS) a $100,000 settlement and take corrective action to implement policies and procedures to safeguard the protected health information of its patients. The settlement with the physician practice follows an extensive investigation by the HHS Office for Civil Rights (OCR) for potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. For assistance developing a HIPAA compliance program or responding to a HIPAA breach, contact Rafael A. Gaitan, Esq. Mr. Gaitan has over 15 years experience in the health care industry and regularly counsels physician practices on regulatory matters including HIPAA and the HITECH rules.
Read MoreOn March 5, 2012, The U.S. Food and Drug Administration (FDA) issued a warning letter to Breathable Foods Inc., makers of AeroShot1, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the
Read MoreThe U.S. Food and Drug Administration (FDA) has asked a federal court to prevent Mexicali Cheese, a New York cheese manufacturer, from continuing to operate because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria. According to a complaint for permanent injunction filed by the U.S. Department
Read MoreThe FDA announced today that it will begin sampling import shipments of orange juice and will deny entry to shipments that test positive for carbendazim. In a letter to industry, the FDA informed that it received information on December 28,2011, that low levels of carbendazim (in the low parts per billion range) was detected in currently marketed finished orange juice products, and orange juice concentrate. The FDA traced the issue back to the 2011 crop of oranges from Brazil, where the carbendazim is a legally used fungicide to combat black spot, a type of mold that grows on orange trees.
Read MoreThe U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued Warning Letters in December 2011 to seven companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss. The letters warn the companies that they are violating federal law by selling unapproved new drugs, and by making
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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