Devices

‘Significant Violations’ at Steiner Clinical Study Site

FDA says that a 12/12-12/16/16 San Francisco District Office inspection at Steiner Biotechnology, Henderson, NV, found objectionable conditions in the firm’s role as sponsor-investigator in significant risk clinical studies of Ridge Graft and Skeletal Graft. According to a just-released 6/21 Warning Letter, the inspection was conducted under a program designed to ensure that data and information contained in requests for IDE, PMA, and 510(k) submissions are scientifically valid and accurate. Another program objective, the letter says, is to ensure that human subjects are protected from undue hazards or risks during the course of scientific investigations. Specific violations noted on an FDA-483 were:

failing to submit an IDE application to FDA and obtain approval from FDA and an institutional review board before allowing subjects to participate in the investigation;
failing to maintain accurate, complete, and current records relating to participation in an investigation; and
failing to obtain informed consent in accordance with the regulations on the protection of human subjects and failing to adhere to informed consent requirements.

The letter notes the company’s statement that it did not conduct an investigation and has done nothing requiring regulatory oversight. It says that the agency disagrees with that assessment and reiterates that investigations on Ridge Graft and/or Skeletal Graft to determine their safety and effectiveness require IDEs.

Steiner was told to respond with documentation of the corrective and preventive actions it has taken or will take to correct the violations and prevent their recurrence, along with dates for each action to be completed and a plan for monitoring corrective action effectiveness.

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