News
Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
Publications
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News
After a long and winding road, FDA finalizes much-debated “intended use” rule
05 August 2021
On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...
Media Mention
Lucira Health's unexpected sprint to a first-of-its-kind EUA from FDA: The inside story
08 April 2021
Partner Jonathan Kahan was quoted in the Medtech Insight article "Lucira Health's unexpected sprint to a first-of-its-kind EUA from FDA: The inside story."
Media Mention
Securing FDA approval for novel OPRA prosthetic wasn't a 'slam dunk.' Here's how start-up Integrum made it through the PMA maze Medtech Insight
16 February 2021
When medtech industry attorney Jonathan Kahan began working with Swedish start-up Integrum AB to secure premarket approval (PMA) from the U.S. Food and Drug Administration for the company's ...
News
HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority
23 August 2020
On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket...
Insights and Analysis
Variable De Novo review metrics -- Plan ahead
09 March 2020
Recent data from the U.S. Food and Drug Administration (FDA or the agency) on the percentage of De Novo classification requests that are declined or withdrawn raises questions about the...
News
Pilot program for 510(k) electronic submissions is requesting participants
02 March 2020
The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket...
News
FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment
25 February 2020
The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an...
News
FDA resumes enforcement relating to laboratory developed tests
11 April 2019
On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory ...
