F
Factoring Humans
Is anyone planning on attending the FDA's Infusion Pump Public Meeting in Silver Springs, MD next week?
FDA Infusion Pump Public Meeting in Silver Springs, MD - May 2010
Detais are here - http :// www .fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm203299.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
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F
Factoring Humans
I attended the FDA's Infusion Pump Public Meeting last week, and was surprised at some of the things I learned.
I expected the FDA's tone to be one of "a Principal scolding misbehaving students," given the rate of recent Infusion Pump recalls - instead the FDA expressed sincere gratitude for the interest and participation of everyone in attendance. I did not expect Infusion Pump Manufacturers to openly express their dismay and frustration with FDA medical device regulations, especially the ambiguity surrounding medical device design regs, yet they did.
I was surprised by the FDA officials in military uniform (those with the US Public Health Service Commissioned Corps), they looked quite dapper.
My biggest surprise was returning from the meeting and investigating all of the "Public Comments" submitted for the official meeting docket. Total number of comments was 2. Given that there were 300 or so people in attendance at the public meeting, many with questions they asked verbally, I find it surprising how few comments were officially submitted.
Although comments are no longer being accepted for the meeting, the FDA is still accepting comments about the Draft Guidance for Infusion Pump Total Product Life Cycle until 6/25/10.
I would encourage anyone with a vested interest in Infusion Pumps to electronically submit their comments via www-dot-regulations-dot-gov and add their voice to this new initiative.
I expected the FDA's tone to be one of "a Principal scolding misbehaving students," given the rate of recent Infusion Pump recalls - instead the FDA expressed sincere gratitude for the interest and participation of everyone in attendance. I did not expect Infusion Pump Manufacturers to openly express their dismay and frustration with FDA medical device regulations, especially the ambiguity surrounding medical device design regs, yet they did.
I was surprised by the FDA officials in military uniform (those with the US Public Health Service Commissioned Corps), they looked quite dapper.
My biggest surprise was returning from the meeting and investigating all of the "Public Comments" submitted for the official meeting docket. Total number of comments was 2. Given that there were 300 or so people in attendance at the public meeting, many with questions they asked verbally, I find it surprising how few comments were officially submitted.
Although comments are no longer being accepted for the meeting, the FDA is still accepting comments about the Draft Guidance for Infusion Pump Total Product Life Cycle until 6/25/10.
I would encourage anyone with a vested interest in Infusion Pumps to electronically submit their comments via www-dot-regulations-dot-gov and add their voice to this new initiative.
Hi Facoring Humans,
Pl check if this is the right link - https://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480adf3f1 ?
Pl check if this is the right link - https://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480adf3f1 ?
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