510k Premarket Notification
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective and
US Representative
The FDA requires any foreign establishment to appoint a United States agent (U.S. agent) for that establishment. To know more, check out our whitepaper. Download
Establishment Registration and Device listing
All companies are required to register their establishments and list their medical devices. To know more please check our whitepaper. Download the White Paper
Overview of FDA 505(b)(2) Regulatory Pathway
Many 505(b)(2) applications do not require the sponsor to conduct nonclinical studies. In these cases, the successful application will contain adequate evidence of safety for
Formal Meetings with FDA
FDA encourages sponsors to consult the agency during their products’ development program through one of its 3 types of formal meeting (Type A, Type-B and
Sakigake Designation for Drugs in Japan
PMDA created a new regulatory pathway known as “SAKIGAKE” that allows the accelerated approval of drugs designated as breakthrough therapies and addressing unmet medical needs
