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

FDA Gives Insight On Changing Approval Landscape

Executive Summary

Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.

You may also be interested in...



Cognoa Seeks De Novo Clearance For AI-Powered Diagnostic App For Autism After Successful Study

FDA clearance of the ASD Diagnostic app could lead to early diagnosis, improving quality of life of children with ASD and their caregivers. 

FDA Finalizes First Two Guidances For 510(k) Pathway That Uses Performance Measurements

The guidances outline testing and performance criteria for Foley catheters and cutaneous electrodes submissions through the new abbreviated 510(k) pathway.

Minding The Middle: FDA Fleshes Out De Novo Regs As The Program Expands

A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT142751

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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