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

Industry, FDA Outline Costs Of New MDUFA Proposals; Quality Management A Strong Focus

This article was originally published in The Gray Sheet

Executive Summary

After months of negotiations, the agency has proposed hiring new staff and making significant changes to their device review process that would cost $500 million – on top of current user fee revenues – and does not account for inflation.

You may also be interested in...



FDA, Industry Agree On Working Groups To Support User-Fee Negotiations

The agency and industry agreed to create working groups allowing subject-matter experts to delve deeper into technical details on some of the key proposals raised thus far in user-fee reauthorization talks. Areas of focus include de novo reviews, pre-submissions and personnel recruitment challenges.

CDRH Prioritizes Leveraging Real-World And Patient-Preference Data, Enhancing Quality

In its 2016-2017 strategic priorities, the device center lays out specific goals for putting more emphasis on real-world postmarket data to support regulatory decisions, making better use of patient-preference input, and enhancing quality at CDRH and in industry. Topping FDA's list: gaining access to 25 million electronic patient records with device identification from global registries, insurance claims data and electronic health records, and expanding that number to 100 million by the end of 2017 to support premarket and postmarket decisions.

New Fundings And Goals To Match Raised In Latest MDUFA IV Session

As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.

Related Content

Topics

UsernamePublicRestriction

Register

MT034585

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