Devices

Medical Device Animal Source Guidance Explained

CDRH Office of Compliance materials engineer Scott McNamee says a final guidance on the use of animal tissues in the manufacture of medical devices succeeds a 1998 guidance that gave the FDA understanding of how to address the risk to the public health from bovine spongiform encephalopathy (BSE). “Since 1998, a great deal has changed in our understanding of transmissible diseases and the impact on the medical device market in particular from the use of materials derived from bovine animals,” he told a 4/23 Webinar.

He said that a 2014 draft guidance was revised to provide clarity on the intersection between recognized standards in the guidance, what information should be documented in a premarket submission versus what information should be maintained in manufacturing facility records, and how to apply the Quality System regulation.

Three key differences between the final guidance and the 1998 version, McNamee said, were (1) the guidance now provides recommendations on viral pathogens and all transmissible spongiform encephalopathies and not just BSE; (2) the guidance outlines information needed related to the sourcing of animal materials and how that information should be provided and documented; and (3) the guidance recommends how viral inactivation studies should show the sum of log reduction of viral load within the steps of the manufacturing process that will lead to a safe product for the market.

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