Devices

Warning Letter Cites ‘Right-to-Try’ Law

A 2/6 CDRH Warning Letter to ExThera Medical Corp. said the company distributed unapproved devices to hospitals without obtaining FDA approval to do so under its open IDE. Writing in an online post, Mintz attorneys Joanna Hawana and Benjamin Zegarelli say ExThera is the sponsor of certain clinical research and compassionate use protocols for an unapproved device system.

In response to the Warning Letter observations, ExThera said, “The device can be distributed and used in certain states based on compliance with federal and state ‘right-to-try’ laws.” The attorneys say FDA flatly rejected that position, noting that the federal right-to-try law is not applicable to medical devices and complying with a state right-to-try law that conflicts with applicable federal law would not relieve the firm of complying with federal law.

The CDRH letter appears to be the first time FDA has cited the right-to-try law that was approved during President Trump’s first term in a Warning Letter or other public notice of violation to a drug or medical device company, the attorneys say.

“As public interest in investigational medical products continues to increase,” they add, “developers may be under greater pressure to make such products available to patients and their healthcare providers. It is critical, however, for companies to ensure that they interpret and apply relevant laws correctly and that their operations are defensible and lawful.”

The post says the ExThera Warning Letter also includes important reminders about the risk of disseminating misleading or promotional statements about unapproved devices, rendering the devices misbranded and adulterated, and a reminder that FDA is reviewing multimedia content created or controlled by a product’s sponsor. For example, it says, CDRH objected to statements made in a podcast featuring the company’s chief medical officer that implied the device was approved by FDA for marketing in the U.S.

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

Read more

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