Author: Song Seto, Ph.D.

The Special 510(k) program was established to create a more efficient review process (30 days instead of the 90 days for Traditional 510(k)s!) for certain changes subject to 510(k) submission requirements. FDA released a new guidance document that supersedes the...

With FDA’s Food Safety and Modernization Act (FSMA), importers were given greater responsibility for ensuring that imported foods are safe. The Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is a program that requires importers...

The Food Safety and Modernization Act (FSMA) was signed into law in 2011, with compliance dates for some businesses beginning in 2016. However, because of the extent of reform, FDA is still working on providing guidance documents and tools that...

Colors can set apart your medical device, drug, food, and cosmetic. But, do you know how FDA permits their use within the US? This blog article reviews the regulations and processes in place for color additives. Color additives, artificial color, or...

The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point. Stem...

FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject to special controls and pre-market notification. Currently, both internal and external surgical staplers are classified as class I, subject to...

Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. Learn more about the combo products pre-market submission reviews and the other mechanism devised by the FDA and things that...

Happy World Immunization Week! Lately, we’ve heard about outbreaks of diseases that we previously thought were preventable. What are some of the latest numbers and what can we do? This week’s blog is a snapshot of the impact of vaccines...

Randomized controlled trials have long been the gold standard for collecting clinical data on investigational medical devices. However, with the increasing costs of conducting trials, difficulty in tracking long-term outcomes, and sometimes mismatch of clinical trial data with practical experience,...