Devices

Standard Conformity is Not Regulation Compliance: Consultant

Halloran Consulting Group principal consultant Michael Wienholt says that the fact that a medical device firm has received ISO 13485 certification does not mean that it is complying with FDA Quality System regulations. “The basic message is that conformity to a standard does not equal compliance with a regulation,” Wienholt writes in a MedDevice Online guest column. “An auditor representing the registrar that issues your ISO certificate is trained to assess conformity to the standard by employing a methodology that is different from that of an FDA inspector, and the consequences for nonconformance are different.”

The post includes a hypothetical example of a violation in design controls, and how it is handled by an ISO auditor and an FDA investigator. “The principal differences between these two examples are the quality system’s level of scrutiny and the significant enforcement actions that FDA can employ as a result of a violative Quality System Regulation inspection,” the post says.

Wienholt concludes that understanding the differences between the ISO standard and the FDA regulation is a key step toward creating a Quality Management System that provides both conformity and compliance.

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