Devices

Guide on Microneedling Product Regulatory Considerations

FDA has issued a final guidance on Regulatory Considerations for Microneedling Products. The document is intended to assist industry in understanding when a microneedling product is a device for regulatory purposes. It also provides information on the regulatory pathway to market for microneedling devices for esthetic use. According to the agency, microneedling products are regulated as devices if they are intended to diagnose disease or other conditions, or cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body. For example, a manual microneedling product with short, blunt needles is a device requiring a 510(k) if the firm makes claims that the product s intended to exfoliate, give skin a luminous look, stimulate collagen production, and treat wrinkles, FDA says.

The guidance also gives examples of a microneedling product that is not a device, such as one with short, blunt needles or “micro-protrusion” tips that do not penetrate living layers of skin and for which the firm claims that the product is intended to facilitate skin exfoliation. A microneedling product with short, densely packed needles that are not designed to penetrate living layers of skin and for which the firm claims that the product is intended to give skin a smoother look and feel would also not be considered a device, FDA 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

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