In the FDA, medical devices are classified into three categories (Class I, II, and III) based on their level of risk. A 510(k) pre-market...

On June 9, 2023, the FDA announced that through eSTAR (The electronic Submission Template and Resource), it is now possible to submit...

The FDA will be hosting the Regulatory Education for Industry (REdI) Annual Conference 2023 free of charge. Date: June 5(Mon) – June...

When examining advertisements for medical devices, it is common to come across the phrase "FDA approved" to enhance the credibility and...

Updated on 9/7/23. On December 29, 2022, the FDA enacted "The Modernization of Cosmetics Regulation Act (MOCRA)." The critical of the...

The FDA approved a treatment for individuals who have amyotrophic lateral sclerosis (ALS) and carry a specific genetic mutation known as...

On March 27, 2023, the FDA update announced that has stopped accepting submissions to the Voluntary Cosmetic Registration Program(VCRP)...

FDA will have a public meeting for good manufacturing practices for cosmetic products. Please save the date: The U.S. Food and Drug...

Mr. Kwon from Provision Consulting Group traveled to South Korea and presented a topic related to the regulatory perspective in the US...

In March, 2023, Mr. Kwon, one of the Co-CEOs of Provision Consulting Group, traveled to South Korea to provide consulting services and...