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Content tagged with Food and Drug Administration

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FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

The FDA today outlined its plans for finalizing guidance on its Breakthrough Device Program as well as plans for a new Safer Technologies Program (STeP) intended to encourage device tech that significantly improves safety as compared to current devices on the market.

FDA updates docs on review of paclitaxel devices for PAD

The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.

FDA wants public input on AI-enabled device regulation

The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence - also known as software-as-a-medical-device (SaMD) - whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared.

Let's Get you Ready for your Clinical Trial | Webinar | US perspective

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FDA Expert Panel Considers Trial Designs for Neurological Devices

Most members of the FDA’s Medical Devices Advisory Committee panel on neurological devices said age should not be a consideration for inclusion in a clinical trial, but life expectancy should, and patients with less than one year of life expectancy should be excluded from studies.

FDA seeks to bring clarity to combination product regulation

The FDA proposes a rule that would amend regulations regarding the classification of products as biological products, devices, drugs or combination products.

Untangling the Complexities of Clinical Trials

genae was interviewed by Pharma Tech Outlook on the complexities of clinical trials. Discover this must-read article and how genae identified an unmet need for excellence in medical device clinical trials.

FDA ramps up scrutiny of materials in medical devices

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.

FDA Panel: Too early to pull textured breast implants over cancer risk, need more data

A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report.