Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Early Signs Positive From FDA's Least-Burdensome Training

Executive Summary

An initial evaluation of US FDA's congressionally mandated staff training programs on "least burdensome" processes are promising, the agency says, but more time is needed to track data on more tangible positive impacts for device companies. Industry, meanwhile, will likely need more convincing.

You may also be interested in...



Least Burdensome Additional-Info Requests? US FDA Needs Metrics, GAO Says

The US Government Accountability Office says FDA needs more information to prove that is properly applying least-burdensome concepts for deficiency or additional-information letters sent to companies while reviewing pre-market submissions. FDA defends its performance, but plans to conduct more assessments.

'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept

The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.

FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT122827

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