Did you read about the Institute of Medicine’s findings regarding FDA 510(k) process? FDA has scheduled a public meeting in response to the IOM findings on September 16, 2011. FDA has also set a September 30 deadline for public comments regarding the report.
FDA 510(k) Still Under Fire
August 3, 2011 By Leave a Comment
Maybe you saw all the news in the past week or so regarding the Institute of Medicine’s (IOM) findings regarding the FDA 510(k) process. In summary, IOM suggests the 510(k) process be scrapped and replaced entirely. As you can imagine, there have been plenty of opinions shared across the web about this report. Here are links to some:
510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release
BREAKING NEWS: IOM’s 510(k) report drops
Could this be the end of the 510(k) process?!
510(k) reform: IOM report a headache the FDA doesn’t need
IOM Recommends the FDA Dump its 510(k) Process
IOM Recommends Replacing 510(k) Clearance Process “As Soon As Reasonably Possible”
IOM’s 510(k) killer is a nonstarter
Flawed Medical Device Approval Process Needs Public Comments, Says the FDA
510(k) reform: FDA opens public comment on controversial IOM report
IOM Press Conference Highlights
I’ve worked in the medical device industry for over 13 years. Maybe I have an industry bias, but I always found the 510(k) process to be a pretty fair and reasonable means to clear devices. What do you think?
November 11, 2010 – 510(k) Reform: Using Recall Data to Analyze the 510(k) System
October 22, 2010 By Leave a Comment
510(k) Reform: Using Recall Data to Analyze the 510(k) System
Rescheduled 510(k) Reform Presentation
November 11, 2010
8:00am-10:00am
If you had previously registered and paid but cannot make the new date please contact rhardin@ihif.org for a refund.
While much has been debated in the 510(k) realm, we have yet to see true statistical data – until now. Ralph Hall, counsel for Baker & Daniels, recently completed the first major study examining the 510(k) system. This presentation, which is sponsored by IHIF, IMDMC and Baker & Daniels LLP, will provide a detailed look into his research and the resulting potential implications for the 510(k) system.
The Institute of Medicine (IOM) is in the midst of an 18-month assessment of the 510(k) system and whether it provides adequate product safety. Hall’s work will be presented to the IOM and those Congressional offices interested in possible changes to the system. Hall’s study will provide the aforementioned policy makers with the critical data they need to make 510(k) guidance decisions.
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Registration Fee: $25 for IHIF and IMDMC members, $75 for non-members
Please bring your check (payable to “IHIF”) to registration on the day of the presentation.
September 15, 2010 – 510(k) Reform: Using Recall Data to Analyze the 510(k) System
September 7, 2010 By Leave a Comment
510(k) Reform – Using Recall Data to Analyze the 510(k) System
While much has been debated in the 510(k) realm, we have yet to see true statistical data – until now. Ralph Hall, counsel for Baker & Daniels, recently completed the first major study examining the 510(k) system. This presentation, which is sponsored by IHIF, IMDMC and Baker & Daniels LLP, will provide a detailed look into his research and the resulting potential implications for the 510(k) system.
The Institute of Medicine (IOM) is in the midst of an 18-month assessment of the 510(k) system and whether it provides adequate product safety. Hall’s work will be presented to the IOM and those Congressional offices interested in possible changes to the system. Hall’s study will provide the aforementioned policy makers with the critical data they need to make 510(k) guidance decisions.
Date: Wednesday, September 15, 2010
Time: 8:00 a.m. EDT I Registration
8:30 a.m. – 10:00 a.m. EDT I Programming
Location:
Indiana University Emerging Technologies Center (IUETC)
351 W. 10th Street
Indianapolis, IN 46202
Registration Fee: $25 for IHIF and IMDMC members, $75 for non-members
Please bring your check (payable to “IHIF”) to registration on the day of the presentation.
