News & Insights
At Accorto Regulatory Solutions we are always keeping a close eye on news in our areas of expertise. Stay up to date with Insights and News from Accorto Regulatory Solutions by signing up for our Newsletter!
News
Accorto Announces Addition of Dr. Kevin Lye as Medical Advisor
RICHMOND, VIRGINIA - NOV. 24, 2023 At Accorto, we strive to continuously look for ways to expand our capabilities to better serve our clients. Today we are excited to announce another key step on our [...]
Use Of International Standard ISO 10993-1, “Biological Evaluation Of Medical Devices – Part 1: Evaluation And Testing Within A Risk Management Process”
FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and De Novo requests for medical devices that come into [...]
CDRH Statement: FDA Continues To Take Steps To Strengthen The Premarket Notification [510(K)] Program
Today, the U.S. Food and Drug Administration issued three new draft guidances to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices. CDRH believes in the merits of the [...]
Insights
Mask Manufacturing Matters – Benefits of Buying Domestic
Mask Manufacturing Matters - Benefits of Buying Domestic It’s no secret that COVID-19 has generated new heights of demand for face masks in the United States that is not going [...]
The PACT Act and What it Means for the Electronic Cigarette Industry
The PACT Act and What it Means for the Electronic Cigarette Industry What it is: On December 27, 2020, the President approved an emergency Covid-19 economic relief and [...]
5 Things Your PMTA Needs to Make it to Substantive Review
5 Things Your PMTA Needs to Make it to Substantive Review Over the past few months, some of the mystery has lifted surrounding the Premarket Tobacco Application (PMTA) process for [...]
