Remove Blog Remove Engineering Remove Medical Remove Specialization
article thumbnail

HP&M Welcomes Senior FDA Official, Ana Loloei, to the Firm

FDA Law Blog

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei graduated magna cum laude , with a degree in Biomedical Engineering with a concentration in Electrical Engineering from The George Washington University. While at FDA, Ms. During her FDA tenure, Ms.

article thumbnail

14th Asia Pacific Symposium on Cochlear Implant and Related Sciences Set to Convene in Seoul — Featuring HP&M’s Dr. Philip Won

FDA Law Blog

Dr. Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. Philip Won , of Hyman, Phelps & McNamara, P.C.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

article thumbnail

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

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

article thumbnail

New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

You can continue to use your insurance for medications and for labs as well. However, with DPC you can find discounts on medications, labs, imaging, and supplements that are passed on to you. The goal is to help you with all your healthcare needs so you can receive the most out of your money and time.

article thumbnail

Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

New South Family Medicine and MedSpa

blog":{"type":"Static","pageId":"tomo1"},"./medspa-policies":{"type":"Static","pageId":"c8gi2"},"./event-list":{"type":"Static","pageId":"lmi71"},"./general-clean":{"type":"Static","pageId":"u6anc"},". in-the-know/our-specials":{"type":"Static","pageId":"u7hat"},"./schedule":{"type":"Static","pageId":"tg6i2"},"./medspa":{"type":"Static","pageId":"hr7g7"},"./meet-the-team":{"type":"Static","pageId":"w0jmf"},".

article thumbnail

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

FDA Law Blog

Koblitz & Philip Won — The first anniversary is always special. That rule went into effect on October 17, 2022, leading us to this blog post about the one-year anniversary. By Jeffrey N. Gibbs & Sara W. Janus-like, it offers the opportunity to simultaneously reflect on hitting a milestone and projecting the future.