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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Provides Guidance On 510(k) Devices With Different Technological Characteristics

This article was originally published in The Gray Sheet

Executive Summary

FDA issues a draft guidance July 15 describing how it weighs the risks and benefits to prove substantial equivalency in 510(k) devices when the new product’s technological characteristics differ from its predicate device.

You may also be interested in...



FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s

A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions for substantially equivalent products with differing technological characteristics.

Australia Looking Into In-Vitro Self-Test Deregulation

In-vitro self-tests for influenza and sexually transmitted diseases as well as direct-to-consumer genetic tests are on the agenda for deregulation in Australia. 

ConMed’s ‘No Smoking’ Drive Has Multiple Benefits In General Surgery

ConMed Corp. is company of two halves  ̶  general surgery and orthopedics – and is readying itself for a renewed assault on these two markets on the back of a technology pipeline, targeted acquisitions and a new growth-winning culture, says CFO Todd Garner.

Topics

UsernamePublicRestriction

Register

MT033157

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

Cancel