The Special 510(k) program was established to create a more efficient review process (30 days instead of the 90 days...
Song Seto, Ph.D.
Foreign Supplier Verification Program for Imported Food
With FDA’s Food Safety and Modernization Act (FSMA), importers were given greater responsibility for ensuring that...
FDA’s Food Safety Plan Builder
The Food Safety and Modernization Act (FSMA) was signed into law in 2011, with compliance dates for some businesses...
One Fish, Two Fish, FD&C Red No. 3 Fish, D&C No. 4 Fish
Colors can set apart your medical device, drug, food, and cosmetic. But, do you know how FDA permits their use within...
Stem Cell Clinic Injunction
The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency...
Reclassification of Surgical Staplers
FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject...
Navigating the US FDA for Combination Products
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 you should include in your pre-market submission.
Power of Vaccines
Happy World Immunization Week! Lately, we’ve heard about outbreaks of diseases that we previously thought were...
Real-World Data to Support Medical Device Regulatory Submissions
Randomized controlled trials have long been the gold standard for collecting clinical data on investigational medical...
U.S. Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
It is likely that you know someone who has received a ligament or tendon replacement, a cornea transplant, or a skin...
Use of Genetic Databases to Advance Diagnostic Test Development
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains...
Mobile Medical Applications
The field of mobile medical applications (apps), software that run on smartphones or other mobile communication...
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