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

On The Virtual Horizon? FDA Revising Software Guidance, Part 11 Policy

This article was originally published in The Gray Sheet

Executive Summary

Stakeholders will have an opportunity to comment on FDA's evolving policy on Part 11 electronic records regulation during a June meeting

You may also be interested in...



Regulatory News In Brief

Modular PMA goals: FDA should complete review of 70% of PMA modules within 90 days, starting in fiscal 2006, AdvaMed proposes in Jan. 7 comments to FDA. Under the plan, 80% of modules would be completed in 90 days in 2007. AdvaMed's review performance targets differ from two proposals FDA offered at a November MDUFMA stakeholder meeting (1"The Gray Sheet" Nov. 29, 2004, p. 4). Under one agency option, 70% of modules would be completed within 120 days in 2006, rising to 80% in 2007. The alternative pledged 50% in 90 days in 2006, increasing to 60% in 2007. FDA's proposals "simply codify current performance levels, which have declined since the passage of MDUFMA," AdvaMed protests in its comments to FDA. Maintaining that user fees provide for additional review resources and that Congress has fully funded FDA for FY 2005 as required by MDUFMA, AdvaMed contends that its proposed targets for the agency are "reasonable and represent appropriate incremental improvement over current review performance"...

Regulatory News In Brief

Modular PMA goals: FDA should complete review of 70% of PMA modules within 90 days, starting in fiscal 2006, AdvaMed proposes in Jan. 7 comments to FDA. Under the plan, 80% of modules would be completed in 90 days in 2007. AdvaMed's review performance targets differ from two proposals FDA offered at a November MDUFMA stakeholder meeting (1"The Gray Sheet" Nov. 29, 2004, p. 4). Under one agency option, 70% of modules would be completed within 120 days in 2006, rising to 80% in 2007. The alternative pledged 50% in 90 days in 2006, increasing to 60% in 2007. FDA's proposals "simply codify current performance levels, which have declined since the passage of MDUFMA," AdvaMed protests in its comments to FDA. Maintaining that user fees provide for additional review resources and that Congress has fully funded FDA for FY 2005 as required by MDUFMA, AdvaMed contends that its proposed targets for the agency are "reasonable and represent appropriate incremental improvement over current review performance"...

Wound Care Reimbursement Reforms Top AdvaMed “Sector” Wish List

Obtaining improved Medicare coverage and coding policies for wound care products will be an objective of a new "sector" being developed by AdvaMed

Related Content

UsernamePublicRestriction

Register

MT019914

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