Devices

AdvaMed Urges Prioritized Work on Guidances

AdvaMed has identified guidance documents that FDA should prioritize in its fiscal year 2019 plan on proposed documents to be developed. In comments to the agency, AdvaMed recommends that FDA finalize several of the draft guidances that it has issued within the last year. For example, the group says the following guidances should have the highest priority:

The Least Burdensome Provisions: Concept and Principles
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Breakthrough Devices Program
Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
Clinical and Patient Decision Support Software
Content of Premarket Submissions for Cybersecurity of Medical Devices of Moderate and Major Level of Concern
Multiple Function Device Products: Policy and ConsiderationsThe Special 510(k) Program
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

Additionally, AdvaMed said the top two draft guidance documents that should be developed are Nonbinding Feedback After Certain FDA Inspections of Device Establishments and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The group says the inspection feedback guide is important because device firms face significant sanctions if they do not correct observations identified during these audits. “Consequently, they often invest massive time and resources in corrections without confidence that these measures meet FDA expectations,” it says. “The nonbinding feedback mechanisms better assures that proposed corrections align with FDA’s view of the remediation that should occur.”

Regarding the software submission draft guidance, AdvaMed contends that the current guidance is over 13 years old (2005) and software practices have changed significantly. “Updating this guidance document would reflect current software development life cycle practices and documentation,” it says.

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