A PricewaterhouseCoopers study shed new light on the regulatory environment for the life sciences industry and the FDA, as well as how the agency is perceived by the public.
The study noted that growing public demand for more medical devices safety, as well as the need to develop medical products faster, is complicating the current regulatory approval process and the relationship between...
A bipartisan group of elected officials from Minnesota sent a letter to Food and Drug Administration Commissioner Dr. Margaret Hamburg recently, raising concerns about proposed recommendations for the premarket review process of medical devices.
The letter, which was signed by eight members of Minnesota’s congressional delegation, noted that “Prompt access to new treatments and cures should be a key consideration in any proposed changes to the 510(k) process. Changes that...
WASHINGTON, DC – The Medical Device Manufacturers Association (MDMA) applauded the efforts by one of America’s leading med-tech entrepreneurs, Dr. Josh Makower, to examine the impact of the current regulatory environment on medical device innovation. Dr. Makower led a study that details how patients in Europe are getting access to new therapies an average of two years before patients in the United States due to regulatory challenges at the FDA.
MDMA President...
I read with great dismay the article “Why the FDA can’t protect the public” written by Shannon Brownlee and Jeanne Lenzer. While it is clear to me that they already made up their minds about the FDA and the medical device community before writing the article, it is unfortunate that they didn’t spend time acknowledging the cutting-edge advancements and improvements to patient care medical devices provide every day.
Health care providers and medical device...
The California Healthcare Institute (CHI) issued a white paper discussing the challenges presented by the current 510(k) process to medical device companies. The white paper, titled "Upcoming Changes to the 510(k) Process: New Approval Pathways and the Impact on Medical Device Development and Innovation," included comments and insights by several MDMA members, and addressed the importance of the of the 510(k) system to the future of medical technology innovation. The report...
A more predictable and reasonable process needed to improve patient care and innovation
WASHINGTON, DC – Innovation and patient care will be significantly enhanced through process improvements that make the regulatory pathway for medical devices more reasonable, predictable and transparent, according to comments submitted by the Medical Device Manufacturers Association (MDMA) to the FDA. MDMA...
FDA officials, industry representatives, patient groups and others kicked-off the opening discussions for the renewal of the Medical Device User Fee Act (MDUFA). The public workshop is the beginning of lengthy discussions to make sure that patients continue to have access to safe and effective medical devices.
MDMA President and CEO Mark Leahey presented at the workshop and noted that MDMA members are on the frontlines of developing and manufacturing cutting edge medical advancements...
Patient and consumer advocates are suggesting FDA request considerably more funding from device companies in the next round of user fee negotiations, but companies are reluctant to foot more of the bill for device reviews without seeing promised improvements in FDA's pre-market program.
FDA held a public workshop Sept. 14 to hear input from stakeholders on how well the user fee program is working and what, if any, aspects of the medical device user fee program should be maintained,...
The FDA’s Office of Device Evaluation released its annual performance review for 2009, which included PMA and 510(k) submissions.
The report showed that total submissions increased 0.6 percent from 2008 to 2009, and that no 510(k)s were granted "expedited" status in 2009.
The report further showed a drop in PMA applications and a 7 percent increase in 510(k) submissions. Specifically, original PMA submissions went from 26 in 2008 to 20 in 2009, a 23 percent decline, while PMA...
The FDA recently held a two hour webinar to discuss their preliminary recommendations and changes to the 510(k) review process. The event was an opportunity for stakeholders and the public to ask questions about specific proposals, and to provide feedback on what impact they might have.
Regarding the proposal for the creation of a Category IIb subset for the 510(k) process, CDRH Director Dr. Jeffrey Shuren commented that “The public will have input. What we plan to do is issue...
