Medmarc Blog (blog.medmarc.com)
Warnings and Labels
A Guide to FDA's Labeling Guidelines on Biosimilars and the Implications for Products Liability
The field of biopharmaceuticals has witnessed significant advancements in recent years, particularly in the realm of biosimilars. Biosimilars are biological products that are similar to an...
FDA Draft Guidance For Predetermined Change Control Plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Since the publication of the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan in 2021, interested parties have been awaiting guidance from...
FDA Publishes Finalized Guidance Document for Pre-Launch Activities Importation Requests (PLAIR)
On March 2, 2022, the US Food and Drug Administration (FDA) published the finalized guidance document titled, “Pre-Launch Activities Importation Requests,” or PLAIR. This document was updated from...
FDA Releases Two Draft Guidance Documents to Advise Manufacturers on Post COVID-19 Protocol
During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) felt pressured to expeditiously authorize new medical devices that could protect the public. Medical equipment such as...
Listing All Constituent Materials in Your Medical Device: The Future of Medical Device Labeling
On May 20, 2021, the FDA’s Center for Radiological Health (CDRH) issued a paper discussing labeling long-term medical devices to include all materials that will come in contact with human...