QUICK GUIDE: FDA PRE-submission process
Abstract: The pre-submission process is a valuable opportunity for medical device developers to engage with the FDA early in the…
The Product Development Process: Pre-Submission for De Novo Applications
Srilekha Deka, 24Jan.2024 Introduction Development of molecular diagnostic products begins with an innovative concept. Developing that concept into a diagnostic…
Antimicrobial Resistance – the escalating global threat
Srilekha Deka, MD, PhD. March 8, 2023. Introduction Antimicrobial resistance is a global public health threat. Antimicrobial resistance (AMR) refers…
The Product Development Process for Medical Devices
The FDA Pre-Submission Process Srilekha Deka, MD, PhD April 30, 2023 Introduction Development of molecular diagnostic products begins with an…