Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
Licensees of the Department of Health are required to renew their licenses biennially in order to maintain the right to practice in the health care industry. The DOH required medical doctors to renew their licenses in two groups: Group 1 – current license will expire at midnight, Eastern Time, January 31, 2014 Group 2 – current license will expire
Read MoreThe U.S. Food and Drug Administration (FDA) issued a warning letter to Jin Han International, Inc., d/b/a Pacific Foods Co., after a facility inspection revealed “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123)”. According to the letter, the
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 MoreCMS sought recovery of an alleged overpayment in excess of $730,000 from a diagnostic laboratory, upon the conclusion and recommendation of Safeguard Services (SGS) to deny all claims submitted for 3,006 Medicare beneficiaries. Mr. Gaitan and Mr. Suarez, of our health care practice group, appealed the overpayment claim through the reconsideration (second level appeal),
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
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