The Center for Devices and Radiological Health (CDRH) issued an update this week on its efforts towards strengthening and developing a more integrated postmarket medical device surveillance system. The recent report details a summary of planned 2013 FDA action on postmarket surveillance. While the report does incorporate some public comments from FDA's UDI draft...
FDA
10/18/2012
While FDA began collecting updated user fees for PMAs earlier this month, new guidance detailing PMA submission and approval was issued this week. The changes in guidance are designed to speed up the review process and meet goals set by the agency. By 2017, FDA hopes to be meeting performance goals 90% - 95% of the time.
"The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain...
09/07/2012
The FDA released a plan this week detailing how it is working to implement their proposal for improvements to the medical device postmarket surveillance system.
The plan, "Strengthening Our National System for Medical Device Postmarket Surveillance," includes strategies the agency is taking to fully implement the Sentinel System, as well as their suggestions on the establishment of unique device identifications (UDI) for medical devices.
To read...
08/02/2012
FDA this week released the user fee rates for 510(k) and PMA submissions in 2013. The new user fees are a part of the MDUFA reauthorization that was signed into law last month and capped nearly two years of negotiations between FDA and various stakeholders.
Included in the reauthorization are new rigorous guardrails designed to improve performance such as "total time" goals for regulatory review, as well as "no submission left behind" policies to ensure regulators are clearly...
07/19/2012
The House Appropriations Committee approved legislation this week that provides funding for the Department of Health and Human Services (HHS), including the Centers for Medicare and Medicaid Services (CMS).
The legislation authorizes a total of $68.3 billion, a reduction of $1.3 billion below last year's level and $1.8 billion below the President's budget request, for HHS. This includes a recommendation of $3.5 billion for CMS managment and operations ("Program...
07/12/2012
The FDA issued draft guidance this week designed to formalize and improve the pre-submission process for medical device innovators. The new program, called "Pre-Sub," is designed after a similar program for drugmakers where regulators and industry meet and agree on specific designs and goals for clinical studies in an effort to improve the regulatory pathway.
"FDA's early feedback on studies can facilitate the development of a quality premarket submission and help...
06/20/2012
WASHINGTON, DC – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding the U.S. House of Representatives passage of S. 3187, the “Food and Drug Administration Safety and Innovation Act:”
“This final legislation represents a strong vision for medical technology innovation over the coming years, and addresses many of the challenges that face our dynamic industry...
05/10/2012
The House Energy and Commerce Committee held a full committee markup this week of H.R. 5651, "The Food and Drug Administration Reform Act of 2012," which consists of all the user fee proposals.
Mark Leahey, President and CEO of MDMA, thanked the leaders of the Committee for having an open and transparent process to improve the user fee programs, noting that patient care is improved when medical device innovators develop new technologies under the assurance of a fair,...
04/24/2012
The Senate HELP Committee marked-up legislation incorporating the various user fees today, including MDUFA. The committee rejected certain amendments that were offered to alter the bill, which highlighted several issues that Members of Congress continue to focus on related to medical device regulations.
MDMA sent a letter to the Committee thanking them for all of their work on this important legislation, and also to highlight concerns as we all move forward.
"We believe that...
