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 Marches Forward With 'STeP' Program To Aid Development Of Significantly Safer Medtech Products

Executive Summary

The US agency is planning to launch another accelerated device approval program along the lines of its successful Breakthrough Devices Program. But this one, the Safer Technology Program (STeP), would focus on devices with enhanced safety features.

You may also be interested in...



Device And Drug Accelerated Approval Pathways Important To Cancer Patients, US FDA Oncology Chief Pazdur Says

The Food and Drug Administration’s increased use of hastened approval pathways for innovative medical products, including new genomic device/drug combinations, has come in for criticism from some US Senators recently. But the patient group Friends of Cancer Research (FOCR) endorsed the approach at a 10 December meeting on Capitol Hill featuring FDA’s Oncology Center of Excellence director Richard Pazdur.

Breakthrough Pathway Final Guidance Eases Sponsor-Regulator Interaction Requirements

US FDA issued a final guidance that sets out requirements for its new Breakthrough Devices Program mandated by Congress. Under the new program, which replaces the Expedited Access Pathway, sponsors have more certainty about how quickly they will get responses from the agency and fewer requirements when setting up early interactions.

FDA Looks To Lead World In Post-Market Device Surveillance With Safety Plan, Investments

US FDA Nov. 20 announced plans for a broad series of updates to its Medical Device Safety Action Plan for the next several months, with the goal that FDA "is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

Related Content

Topics

UsernamePublicRestriction

Register

MT124397

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