The first anniversary is always special. Janus-like, it offers the opportunity to simultaneously reflect on hitting a milestone and projecting the future. The first anniversary can also prompt a taking of stock: how well did the first year go? Recently, the over-the-counter (OTC) hearing aid rule, …
WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, …
The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea. This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent …
For more than three decades, FDA has claimed that the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here). In this post, we summarize the purported basis …
In our June blog post, we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies. FDA uses this program to help it identify risks and to determine whether further investigation is needed. Because this …
As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource (eSTAR). The same template can also be used for De Novo submissions. Currently, eSTAR is voluntary for medical device De Novo submissions, but …
Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. Such data may be needed to demonstrate substantial equivalence to a previously-marketed predicate device or, less frequently, to show …
On September 15, 2023, FDA released a final guidance document titled “Breakthrough Devices Program.” Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities …
The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The …
As we recently blogged, FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “Evidentiary Expectations for 510(k) Implant Devices.” Implant devices are used in a range of settings such as …
As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the …
It’s the moment we’ve all been waiting for, dreading, anticipating . . . . Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. The proposed rule has a …
Over the last three and a half years, meetings with FDA were conducted virtually. During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform. Now, in addition to engaging with FDA via Zoom, medical device sponsors can once again …
On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: …
Following up on our first post discussing Digital Health Technologies (DHTs) (here), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. Earlier this year, FDA hosted a public meeting, Understanding Priorities for the Use of Digital …
