Scott Danzis practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading
On October 24, 2016, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register announcing the indefinite extension of the Parallel Review Program. The agencies’ decision was based on “positive experience” from the Parallel Review Pilot Program, which has allowed manufacturers to … Continue Reading
Yesterday, FDA issued a Notice announced that it will be holding a 2-day public hearing on November 9-10, 2016 on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” In the Notice, the agency explained that “FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved … Continue Reading
FDA recently published two draft guidance documents related to the development of devices that utilize next generation sequencing (NGS) technologies. These two draft guidances support the Administration’s Precision Medicine Initiative (PMI), which is intended to promote technologies that use genetic, environmental, and other data to tailor health care tools to unique needs of individual patients. … Continue Reading
On September 24, 2015, FDA published a proposed rule that, if finalized, would amend the agency’s regulations defining “intended use” for drugs and devices. Given the central role that “intended use” plays in FDA’s regulatory system, we regard this as an important development. Background The concept of “intended use” has long served as a fundamental … Continue Reading
FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies. Although FDA reportedly has approached app developers in the past about obtaining 510(k) clearances for their products, this is the first time that FDA … Continue Reading
Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at FDA, recently described the regulatory environment for personalized medicine as “chaotic,” noting the need for FDA to provide better clarity on many issues. Indeed, a strategic priority for the Center for Devices and Radiological Health (“CDRH”) in 2013 is to further … Continue Reading