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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 90 FDA sends final MDUFA Decision on 510(k).

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The New FDA Draft Human Factors Guidance: A Bridge Too Far

FDA Law Blog

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. as a de novo special control or in a guidance document for a specific device type).

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New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

New South Family Medicine and MedSpa

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Folate (folic acid) helps the body form red blood cells.

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Do You Hear What I Hear? One Year of OTC Hearing Aids

FDA Law Blog

Koblitz & Philip Won — The first anniversary is always special. The rule also aimed to provide “consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options.” By Jeffrey N. Gibbs & Sara W. Access has expanded.