On September 20, 2024, FDA released draft guidance titled “Chemical Analysis for Biocompatibility Assessment of Medical devices”. The guidance...
The distinction between “servicing” and “remanufacturing” has often caused confusion throughout the medical device industry. Consequently, earlier...
Earlier this month, the FDA published a Discussion Paper titled “Health Equity for Medical Devices”. According to the CDC, Health Equity is “the...
On August 6, 2024, the Audit Approach document under the Medical Device Single Audit Program (“MDSAP”) was updated to Version 009. As a reminder,...
The impact of Artificial Intelligence (“AI”) is being seen throughout society, and the medical device community is no exception. Regulatory bodies...
The FDA recently announced its planned enhancements to the Electronic Medical Device Reporting (eMDR) System. The purpose of the announcement was to...
Earlier this year, the FDA’s Center for Devices and Radiological Health (“CDRH”) published a new public dataset to assist chemistry laboratories in...
