Robinson Bradshaw

Topic: medical devices

Removing the Cables: New FCC Rule Paves Way for Utilization of Wireless Medical Technology

Amit Bhagwandass is a rising third-year student at University of North Carolina School of Law. New rules adopted by the Federal Communications Commission (FCC) have an appreciable impact on the way that hospitals, nursing homes and other inpatient and outpatient health care providers will monitor their patients in the future. The new FCC rules enable […]

Weekly Roundup: Science Funding, DTC and Medical Device Caucusing

With so many developments at the intersection of genomics and the law, there are 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. Here we recap several recent key developments and, at bottom, round up all of the recent […]

The FDA and DTC: Time to Set the Record Straight

Earlier this month an FDA advisory panel met for two days to consider a range of issues pertaining to clinical direct-to-consumer (DTC) genetic testing. The non-voting advisory panel’s discussion (pdf), including whether certain genetic tests or categories of tests should be made available only through qualified healthcare professionals, sparked considerable controversy (see here for a […]

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 […]

Breaking: FDA Moves to Broadly Regulate LDTs

Earlier today, the U.S. Food and Drug Administration (FDA) announced that it will hold a public meeting July 19-20 to “discuss how the agency will oversee laboratory-developed tests (LDTs).” The FDA has made several high-profile announcements over the past month – particularly in the area of direct-to-consumer (DTC) genetic testing – but today’s development, despite its not […]

Breaking: Congressional Committee Requests Additional Information Regarding 23andMe Sample Swap

Nearly a month ago we reported that the House of Representatives Committee on Energy and Commerce had launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to several of the most prominent DTC companies: 23andMe, Pathway Genomics and Navigenics. Today the Committee has followed up with another letter, this one directed to 23andMe president […]

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 […]

Of Drugstores and Devices: Parsing the FDA’s Evolving DTC “Policy”

Andrew Pollack of The New York Times reports that, in an interview, OIVD Director Alberto Gutierrez indicated that the saliva collection kit Pathway had planned to sell through Walgreens may be a clearer case of a DTC genetic test subject to FDA oversight. According to Director Gutierrez, “Once you take a collection device and you […]

FDA Puts the Brakes on Pathway-Walgreens Pairing; What’s Next for DTC?

Well that was quick. On Tuesday, Pathway Genomics and Walgreens announced a partnership to sell a saliva collection kit for Pathway Genomics’ direct-to-consumer (DTC) genetic tests in Walgreens’ thousands of drugstores nationwide. Less than forty-eight hours later, after the FDA repeatedly voiced its concerns about the arrangement, Walgreens has hit the brakes. According to an […]