FDA Policy/General

Inspections Reviewing More Promo Materials: Law Firm

FDA has stepped up its surveillance of promotional materials during inspections, according to a client bulletin by Arnall Golden Gregory. The law firm says several recent Warning Letters to medical device companies have cited unlawful promotions, including the most recently released letter to Spectrum Medical in Gloucestershire, UK. The inspection also found Quality System Regulation violations in the firm’s manufacturing of unapproved Quantum Perfusion Systems medical devices. The Warning Letter said the firm markets several devices with indications beyond what the agency cleared in its 510(k) for the devices. The letter also says changes to the device’s scope of indications required the submission of a new 510(k).

The law firm notes that it appears an FDA inspection and not a trade complaint or routine monitoring of marketing materials prompted the Warning Letter. “A Quality System Regulation inspection does not have to be limited to quality and manufacturing issues,” it writes. “Once FDA is in the facility, it has wide discretion in what it can review (although there are limitations on its authority, not discussed here).”

Additionally, the law firm says the “agency acknowledged that the company had a number of cleared 510(k) devices (and, at times, prepared a Letter to File explaining its rationale for not submitting a new 510(k)). However, FDA concluded the promoted uses went beyond the scope of the clearances, as the changes and claims constituted ‘a major change or modification to its intended use.’ It did not help the company that the types of products at issue were used for a specific surgical procedure and were life-sustaining. A Letter to File that explains a company’s position not to submit a new 510(k) may help minimize a risk, but it does not eliminate risk if FDA disagrees with the company’s decision.”

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