Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


US FDA says use of spilt predicates is inconsistent with 510(k) device programme

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has issued draft guidance explaining the critical aspects of its pre-market notification, or 510(k), programme under which it clears medium- to low-risk medical devices if they are found to be "substantially equivalent" to a previous legally marketed device (also known as a predicate device)1,2. The document explains how the agency makes substantial equivalence determinations.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts