Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), all pesticide products (including surface sanitizing products) must be registered with the Environmental Protection Agency (EPA) prior to sale, distribution, or use in the United States.
Health Law Scan
Legal Insights and Perspectives for the Healthcare Industry
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. The announcement has implications not only for LDTs intended for SARS-CoV-2 testing, but also for LDTs intended for other purposes, such as pharmacogenetic testing and direct-to-consumer testing.
We are pleased to announce that we are participating in three upcoming digital health events.
Healthcare is a highly regulated space, and regulators are continuing to issue new policies and regulations to address the critical needs for goods and services to combat the coronavirus (COVID-19), while also protecting the public health. Companies beyond just healthcare and life sciences should be aware of the relevant regulatory and legal requirements to avoid enforcement and liability requests.
As discussed in an earlier blog post, US President Donald Trump signed the Further Consolidated Appropriations Act, 2020, into law on December 20, 2019.
The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software.
We invite you to join us in Houston on September 12 for our Second Cup of Coffee breakfast series covering the latest legal developments in digital health and healthcare innovation.
Could a new FDA regulatory approach for postmarket changes to artificial intelligence (AI)/machine learning (ML)–based software devices be in our future?
Did you catch our most recent edition of Fast Break? If not, we had an awesome extended session with Michele Buenafe on May 16 that was also part of our annual Technology May-rathon series.