Whitepapers
Abstract: The pre-submission process is a valuable opportunity for medical device developers to engage with the FDA early in the product development cycle. This process allows for feedback on development plans, testing protocols, and clinical trial designs, helping streamline regulatory approval. While non-binding, the FDA’s guidance can reduce unnecessary studies…
Read More
Introduction Development of molecular diagnostic products begins with an innovative concept. Developing that concept into a diagnostic product involves multiple coordinated steps. Regulatory agencies like the Food and Drug Administration (FDA) that govern the development of in vitro diagnostic (IVD) products have set up guidelines that need to be followed…
Read More
Introduction Antimicrobial resistance is a global public health threat. Antimicrobial resistance (AMR) refers to the ability of microorganisms, such as bacteria, viruses, fungi, and parasites, to resist the effects of antimicrobial drugs that were previously effective in treating infections. AMR resulted in approximately 5 million deaths in 2019 and killed…
Read More
The FDA Pre-Submission Process Introduction Development of molecular diagnostic products begins with an innovative concept. Developing that concept into a diagnostic product involves multiple coordinated steps. Regulatory agencies like the Food and Drug Administration (FDA) that govern the development of in vitro diagnostic (IVD) products have set up guidelines that…
Read More