Devices

QSR Proposed Revisions Will Advance Harmonization: Post

Pharmatech Associates managing director Stephanie Gaulding says proposed revisions to FDA’s Quality System Regulation for medical devices “is a significant step toward global harmonization and reduces the amount of U.S.-specific regulations for medical device manufacturers, especially relating to structure and requirements for a medical device quality management system.” In a Med Device Online post, Gaulding reviews some of the changes in terminology that will still require U.S.-specific terms because either they are not included in the harmonized document or the definition in that document conflicts with FDA institutionalized terminology.

She also notes a “subtle” change in the regulation title from Quality Systems Regulation to Quality Management System Regulation. “While this seems insignificant,” she writes, “think about how many places this title may be listed. Given the one-year proposed transition period for the revised regulation, manufacturers will need to review in-house terminology against the proposed definitions and terminology to identify where changes are needed within their own quality management system infrastructure. For medical device manufacturers (including those who manufacture components that have never implemented ISO 13485:2016, more significant updates will be required to comply with the proposed Quality Management System Regulation.”

Gaulding says one significant change resulting from the proposed FDA revision would be replacing the Quality Systems Inspection Technique approach to medical device manufacturing facility inspections with a yet-to-be-developed document on inspectional approaches for medical device manufacturers.

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