Regulatory

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, medical device manufacturers are interested...

For medical devices, ISO (International Organization for Standardization) is one of the most significant organizations. ISO issues international standards. Often, national or regional standards organizations adopt the international standards and change their designations. The current international standard for medical device risk management is ISO 14971:2007....

It is likely that you know someone who has received a ligament or tendon replacement, a cornea transplant, or a skin graft. If these tissues were derived from humans, are these products regulated by FDA? This blog will provide an overview of the regulatory framework...

In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for developers of genetic tests. Upon completion...

The government has temporarily “re-opened” until Feb 15th after the longest government shutdown in US history that lasted for 35 days. Here’s what’s going to happen: Some FDA officials carried out inspections and other critical activities without being paid to continue to respond to threats to public...