Robinson Bradshaw

Topic: 510(k)

House Holds mHealth Hearings, FDA Promises Final Guidance Forthcoming

Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th). The hearings, convened jointly by several subcommittees of […]

23andMe Seeks FDA Clearance (Podcast)

Last week, personal genetics company 23andMe announced that it had formally delivered the first round of documentation to the U.S. Food and Drug Administration (FDA) in an attempt to receive 510(k) clearance for its consumer product. 23andMe declared itself “first in the [ direct-to-consumer (DTC) genetic testing] industry to announce it is working towards FDA […]

Weekly Roundup: FDA Regulations, Science Funding and Newborn Screening

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of […]

The Business Effects of Regulatory Uncertainty in Genetic Testing

The business of genetic testing has progressed rapidly, if unevenly, over the past several years. Like any business based on new and rapidly developing science, the promise of new products and markets is counter-balanced by the obstacles of developing commercial products from raw science, fostering markets for those products, constructing profitable business models and overcoming […]

The Cost of Regulating LDTs

Jeffrey N. Gibbs is a director at the law firm of Hyman, Phelps & McNamara and specializes in FDA-related matters. For many years, the Food and Drug Administration (FDA) has taken the position that while it has the authority to regulate laboratory-developed tests (LDTs) as devices, the agency would exercise its enforcement discretion and not […]

What Five FDA Letters Mean for the Future of DTC Genetic Testing

The FDA has published online letters sent to five personal genomics companies – 23andMe, Navigenics, deCODE Genetics, Knome and Illumina – informing the companies that they are manufacturing and selling medical devices without appropriate FDA premarket review and approval. No surprise that the news that the FDA has sent out letters to some of the […]