News
“The news of the discovery spread fast all over the country . . . ” — Howard Carter
Christine P. Bump to Speak at FDLI Enforcement Conference
Penn Avenue Law’s Christine P. Bump will be participating in the panel, “Digital Health: Enforcement, Regulations, and Risks,” as part of the Food and Drug Law Institute’s virtual Enforcement, Litigation, and Compliance Conference on December 15-16. Hear from your peers about how they are staying compliant and inspection ready…
FDA Cannot Claim Regulatory Authority Over LDTs – But Labs Must Be Mindful, and Public Health Remains a Priority
On August 19, 2020, HHS settled a debate that began nearly 30 years ago: FDA cannot regulate laboratory developed tests (LDTs) until and unless the agency presents its authority to do so through notice-and-comment rulemaking. This decision by HHS includes LDTs related to COVID-19…
Opportunity for Stakeholders to Impact FDA’s “Non-Device” Software Report
There is still time for stakeholders to impact FDA’s 2020 update to its congressionally mandated report on best practices for “non-device” software, i.e., software functions excluded from the definition of medical device by the 21st Century Cures Act. Stakeholder comments, which can provide further evidence…
Penn Avenue Law & Policy Evaluates COVID-19 Tests for Healthcare Client
COVID-19 testing is a rapidly evolving domain. Millions of concerned individuals are seeking COVID-19 tests. Meanwhile, testing healthcare providers continues to be essential, and facility-wide testing is becoming necessary for nursing homes and other senior care communities. When a national healthcare…