Devices

VALID Could Hurt Home Sample Testing: Attorneys

Attorneys Gail Javitt and Jeffrey Gibbs (Hyman, Phelps & McNamara) say the “grandfathering” provision in the proposed VALID Act to regulate laboratory-developed tests (LDTs) could adversely affect in-home specimen collection used in telehealth applications. Writing in their firm’s FDA Law Blog, the two say it does not appear that inhibiting telehealth laboratory services is a goal of the legislation. Rather, they say, it is an inadvertent side effect of the rush to approve legislation that has never been considered by a House committee or by either chamber as a standalone bill.

Javitt and Gibbs say that under the grandfather provision, laboratories may continue performing their LDTs on home-collected specimens only if the specimen collection devices have been specifically authorized for such use or, for devices that are otherwise exempt from FDA review, the device’s use is deemed consistent with the limitations on the exemption.

“Since very few specimen collection devices include home use indications and FDA could take the view that an otherwise exempt device forfeits the exemption if intended for home use, the VALID Act may effectively limit the performance of LDTs to specimens collected in a healthcare setting,” the attorneys write. “Thus, this seemingly insignificant clause in VALID could have far-reaching, unintended consequences. This makes us wonder what else is lurking in this nearly 250-page, 43,000-word bill that could have far-reaching, and unintended, consequences…. The seemingly inadvertent limitation on home testing for telehealth stands as a warning sign that the effects of the bill should be better understood by Congress before the bill is enacted.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome