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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. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

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Bathrooms “R” Us

Physician's Practice

Reynolds Blog Article The small details, like restroom cleanliness, shape patient perceptions and impact healthcare experiences in practices. This may cause you to question the airline’s attention to details like engine maintenance or losing passenger’s luggage. Please share your stories for a future article at doctorwhiz@gmail.com.

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

FDA Law Blog

For those who are unfamiliar with the rule, let us briefly explore its history across three different administrations (see our previous blogs: here , here , and here ). Reportedly, buyers of OTC hearing aids tend to be younger and seek a simple process without appointments or prescriptions. Access has expanded.