News & Insights
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News
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 [...]
What MoCRA Means for the US Cosmetics Industry
On December 29, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) was passed into law in the United States. The first major update to the Food and Drug Administration’s (FDA) authority over the cosmetics [...]
Insights
FDA Releases Long Awaited PMTA Submissions List
FDA Releases Long-Awaited PMTA Submissions List May 20th, 2021 Today, May 20th, 2021, FDA released the “Deemed New Tobacco Product Applications Lists” the electronic nicotine delivery systems (ENDS) industry has [...]
What FDA’s Recent PMTA Denials Mean for the E-Cigarette Industry
What FDA's Recent PMTA Denials Mean for the E-Cigarette Industry Background With the FDA’s deadline of September 9, 2021 to finalize the review of all PMTA’s that had [...]
Differences in US FDA Medical Device Classifications
Differences In US FDA Medical Device Classifications In the United States, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who [...]
