Devices

Expanded Standard in Special 510(k) Program Guidance

Hogan Lovells attorneys say that a 9/28 FDA draft guidance, The Special 510(k) Program, “introduces a different, more expansive standard for assessing which devices are eligible for review under the program.” In an online post, the attorneys say the modified standard may enable medical device manufacturers to obtain a faster and less burdensome review for a broader scope of device modifications.

The post says the draft guidance updates the Special 510(k) pathway to:

expand eligibility to cover certain changes to the indications for use; and
clarify eligibility with respect to technological changes.

Under the revised framework, it says, proposed changes that are made and submitted by the manufacturer authorized to market the existing device would be eligible for the Special 510(k) pathway when:

performance data are unnecessary; or
performance data are necessary, but well-established methods are available to evaluate the change and all data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.

“The practical implications are similar to those under the existing standard, but the new draft guidance provides a clearer roadmap for assessing Special 510(k) pathway eligibility,” the attorneys write. “In particular, it offers more granular guidance on the types of changes that are and are not eligible and clarifies the types of data FDA considers appropriate for supporting a modification under this pathway.”

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

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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