In this article, we are going to see the timelines and regulatory pathways for medical devices, Small molecules drugs, etc.

Regulatory pathways for New Chemical entities:

Small molecules drugs are chemically synthesized ones i.e. new molecules – Traditional NDA application is the regulatory pathway for getting approval of new chemical entities by the FDA. Timelines for a new drug application approval range from eight years to twelve years. NDA application is reviewed by the FDA to determine whether a drug is suitable for its intended use. This is done by reviewing the preclinical data and clinical data submitted along with new drug applications and determining whether the drug is safe and effective for its intended use.

Medical Devices Regulatory Pathways and Timelines:

Premarket notification 510k and Premarket Approval are the regulatory pathways for medical devices. The expected approval time for premarket notification 510k is around 1- 3 years and for Premarket approval is around 2-7 years. Medical devices are instruments, apparatus, or devices intended for the diagnosis, treatment, or prevention of diseases. These are classified into three classes. Class 1 devices are low-risk devices marketed using 510k whereas Class II & Class III devices are high risk devices marketed using PMA.