Table of Contents
What are the stages of medical device development?
The Device Development Process
- Device Discovery. and Concept. Device Discovery and Concept.
- Preclinical Research. – Prototype. Preclinical Research–Prototype.
- Pathway to Approval. Pathway to Approval. Devices are tested on people to make sure they are safe and effective.
- FDA Review. FDA Review.
- FDA Post-Market. Safety Monitoring.
What are the 4 phases of clinical trials of medical devices?
In our previous article, “Introduction to Clinical Trials”, we talked about how clinical research is broken up into a series of “phases”, each with a different distinct purpose, beginning with (though not always conducted) pilot studies, then safety testing, then efficacy testing, then clinical efficacy, and, if …
What is the FDA approval process for medical devices?
There are 3 basic processes to obtain FDA marketing approval for medical devices, depending on the nature of the device and the circumstances under which approval is sought: 1) the PMA process; 2) the PMN process; and 3) the humanitarian device exemption (HDE) process.
What should not be reported to MedWatch?
What Not to Report to FDA MedWatch:
- Tobacco product problems.
- Vaccines.
- Investigational (study) drugs.
- Mandatory reporting required by regulated industries (Drugs and Biologics, Devices)
- Dietary Supplements.
- Veterinary Medicine Products.
What are 3 different types of applications for medical devices submitted to the FDA?
The most common types of premarket submissions include: 510(k) (Premarket Notification) PMA (Premarket Approval) De Novo Classification Request.
What is FDA approval process for medical devices?
3 Basic Pathways to Medical Device Approval. There are 3 basic processes to obtain FDA marketing approval for medical devices, depending on the nature of the device and the circumstances under which approval is sought: 1) the PMA process; 2) the PMN process; and 3) the humanitarian device exemption (HDE) process.