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…intent to preempt state law is expressly set forth in a statute. For instance, § 521 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) expressly preempts state law imposing…
…account for certain instances of adverse events and product problems in order to ensure safety issues can be identified and addressed quickly. The FDA recently revised MDR policies and published…
…with the Medical Device Reporting (MDR) regulation (21CFR 803). The FDA requires device companies to account for certain instances of adverse events and product problems in order to ensure safety…
…strong working knowledge of core FDA competencies. Call for Speakers Now Open The next installment of the conference will take place on March 11-12, 2015 in New York City. Planning…
Many marketing applications for in vitro diagnostics (IVDs) need to be supported by clinical data. This is especially likely for new analytes or new intended uses. In some instances, the…
…the author, Deputy Attorney General Paul J. McNulty). In reality, the McNulty Memorandum generally replicates the two memos it replaced. For instance, it leaves largely unchanged DOJ’s “General Principles” for…
…Web made possible nearly instantaneous global transmission of information about medical products. It appeared that FDA might be forced to rethink its entire approach to regulating advertising and promotion, especially…
Displaying investigational and unapproved devices at trade shows, in directed mailings, and on the Internet is important to the vitality of the medical device industry. For instance, to attract investment…
…FDA-imposed REMS requirements. Given the powerful resources available to the government, the key is to avoid scrutiny in the first instance. This article provides tips on how to minimize risk…