Predicate Medical Device Definition

How to Find and Effectively Use Predicate Devices | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/how-find-and-effectively-use-predicate-devices

Information which can be useful to find a predicate device includes: names of similar devices - traded name under which the device is marketed; manufacturer (s) of the similar device (s ...

Premarket Notification 510(k) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

What is a Predicate Device (PD)? | Glossary

https://www.proximacro.com/glossary/predicate-device

A predicate device (PD) is a medical device that may be legally marketed in the U.S, and used as a point of comparison for new medical devices seeking approval through FDA’s 510 (k) …

Predicate Device | Greenlight Guru

https://www.greenlight.guru/glossary/predicate-device

A predicate device is a medical device that may be legally marketed in the U.S. and used as a point of comparison for new medical devices seeking approval through FDA’s …

How FDA Defines Substantial Equivalence to a Predicate …

https://globalregulatorypartners.com/wp-content/uploads/2018/11/GRP-Whitepaper-PredicateDevice-V3.pdf

Predicate Device The concept of substantial equivalence of medical devices was introduced by the US Food and Drug Administration (FDA) as part of the Medical …

510(k) Submission: Clearance & Selecting a Predicate …

https://www.goddardtech.com/product-development/510-k-submission-clearance-selecting-a-predicate-device/

The predicate device is the legally marketed product with which a medical device developer compares its experimental device. Remember, according to the FDA’s …

FDA Guidance on Evaluation of Substantial Equivalence: …

https://www.regdesk.co/fda-guidance-on-evaluation-of-substantial-equivalence-predicate-devices/

At the same time, the authority explicitly states that reference devices should not be considered predicate devices. Hence, medical device manufacturers should not …

Predicate Device - an overview | ScienceDirect Topics

https://www.sciencedirect.com/topics/engineering/predicate-device

This validation of the predicate device was described in a 2018 publication [29].Three trained medical technologists validated the device by comparing data obtained from it …

Identifying Predicate Devices in Asian Countries

https://asiaactual.com/blog/identifying-predicate-devices-in-asian-countries/

The term “ predicate device” refers to a locally licensed medical device with a similar intended use and design/function (to a medical device newly created by a manufacturer) and is crucial to …

4 Steps to Master Substantial Equivalence (510k process)

https://easymedicaldevice.com/substantial-equivalence-on-a-fda-510k-process-how-to-demonstrate-it/

Substantial Equivalence Definition: LINK (i)(1)(A) For purposes of determinations of substantial equivalence under subsection (f) and section 520(l), the …