Devices

Webinar Explains 510(k) Change Guidance

A 11/16 FDA webinar explained requirements in two recent final guidances on when to submit a 510(k) for a change to an existing device and when to submit a 510(k) for a software change to an existing device. During the program, CDRH acting associate director for regulations and guidance Rebecca Nipper outlined the 10 principles that underlie both guidances:

if a change is intended to significantly affect the safety or effectiveness of a medical device, such a change would likely require a new 510(k) submission;
make a risk-based assessment to determine whether a change would significantly affect the device and confirm any decision that a new 510(k) is not required through routine verification and validation activities;
after considering whether a change was made with the intent to significantly affect safety or effectiveness, also consider whether the change could have unintended consequences;
risk management plays a central role in determining when a change could significantly affect safety or effectiveness;
when there are multiple changes, they should be assessed both separately and together;
conduct a risk-based assessment comparing the changed device to the device even previously found to be substantially equivalent in the most recently cleared 510(k);
when the cumulative effect of individual changes triggers the regulatory threshold for submission, submit a new 510(k);
when a change is made to a device, comply with the Quality System regulation requiring, among other things, that device changes be documented;
when a 510(k) is submitted for a device with multiple changes, it should describe all changes that trigger the requirement for submission of a new 510(k) as well as other changes since the most recent 510(k);
even though one correctly follows the guidance and submits a new 510(k) when necessary, a substantially equivalent determination is not assured.

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