When a manufacturer desires to make a change to a Class III device that has been approved via a Premarket Approval (PMA) or product development protocol (PDP) that affects the device’s safety and effectiveness (new indication for use, a change to the labeling, new manufacturing site, etc.) or a change to a Humanitarian Device Exemption (HDE) that affects its safety and probable benefit, a supplement application is required.
This article explores the different types of published literature that can support Class III Medical Device submissions for FDA compliance.
Get the article here
The article is free!
Simply fill in the form below, verify your email address
and you’ll be sent a link to download the article.
Please wait...
Related Posts
- 61By Donna Mitchell-Magaldi, Nerac Analyst, On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev 3 is the…
- 54By Ron Sills, Nerac Analyst, and Donna Mitchell-Magaldi, Nerac Analyst Originally Published: September 26th, 2014 In 2009, the European Commission released MedDev 2.7.1 Rev.3 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” as a supplement to the requirements of the EU Medical Device Directive 93/42/EEC. In order for medical devices to be marketed in…
- 47By Richard Conforti, M.S., Nerac Analyst, Originally Published: April 19, 2016 In 2014 the Chinese Food and Drug Administration, CFDA, updated their regulations on medical devices. These updates substantially changed the way in which a medical device company, particularly international companies not based or founded in China, registers their devices in China. In part 1…