Comments for Anson Group http://www.ansongroup.com Enhancing Value in Medical Technology Thu, 04 Aug 2011 01:22:26 +0000 hourly 1 http://wordpress.org/?v=3.1 Comment on IOM Press Conference Highlights by FDA 510(k) Still Under Fire http://www.ansongroup.com/iom-press-conference-highlights/#comment-211 FDA 510(k) Still Under Fire Thu, 04 Aug 2011 01:22:26 +0000 http://www.ansongroup.com/?p=367#comment-211 [...] IOM Press Conference Highlights [...] [...] IOM Press Conference Highlights [...]

]]> Comment on Could this be the end of the 510(k) process?! by FDA 510(k) Still Under Fire http://www.ansongroup.com/could-this-be-the-end-of-the-510k-process/#comment-210 FDA 510(k) Still Under Fire Thu, 04 Aug 2011 01:21:24 +0000 http://www.ansongroup.com/?p=365#comment-210 [...] Could this be the end of the 510(k) process?! [...] [...] Could this be the end of the 510(k) process?! [...]

]]> Comment on Anson’s Initial Assessment of FDA’s Mobile Medical App Draft Guidance by Do You Understand the FDA’s Mobile Medical “Guidance”? http://www.ansongroup.com/ansons-initial-assessment-of-fdas-mobile-medical-app-draft-guidance/#comment-205 Do You Understand the FDA’s Mobile Medical “Guidance”? Mon, 25 Jul 2011 13:27:41 +0000 http://www.ansongroup.com/?p=352#comment-205 [...] Stout of Anson Group wrote an analysis of the FDA’s mobile medical draft guidance in which he highlights significant statements he gleaned from the FDA’s document and provides [...] [...] Stout of Anson Group wrote an analysis of the FDA’s mobile medical draft guidance in which he highlights significant statements he gleaned from the FDA’s document and provides [...]

]]> Comment on Increased FDA 510(k) Clearance Times by Does the FDA clearance process need an overhaul? http://www.ansongroup.com/increased-fda-510k-clearance-times/#comment-194 Does the FDA clearance process need an overhaul? Fri, 08 Jul 2011 12:25:52 +0000 http://www.ansongroup.com/?p=327#comment-194 [...] But, why are the reviews at FDA taking longer? As part of the MDUFMA/FDAAA reauthorization in 2007, FDA made a promise for interactive review process in a commitment letter to Congress. The Agency stated that it “will continue to incorporate an interactive review process to provide for, and encourage, informal communication between FDA and sponsors to facilitate timely completion of the review process based on accurate and complete information.” The purpose of the interactive review process is to prevent unnecessary delays in the completion of the review, to avoid surprises to the sponsor at the end of the review, and to minimize the number of review cycles. This process would benefit both FDA and 510(k) sponsors, but are reviewers using this process? According to a presentation made by FDA in March 2011, FDA reviewers utilized the interactive review process less in 2010 than they had in previous years. [...] [...] But, why are the reviews at FDA taking longer? As part of the MDUFMA/FDAAA reauthorization in 2007, FDA made a promise for interactive review process in a commitment letter to Congress. The Agency stated that it “will continue to incorporate an interactive review process to provide for, and encourage, informal communication between FDA and sponsors to facilitate timely completion of the review process based on accurate and complete information.” The purpose of the interactive review process is to prevent unnecessary delays in the completion of the review, to avoid surprises to the sponsor at the end of the review, and to minimize the number of review cycles. This process would benefit both FDA and 510(k) sponsors, but are reviewers using this process? According to a presentation made by FDA in March 2011, FDA reviewers utilized the interactive review process less in 2010 than they had in previous years. [...]

]]> Comment on It’s a Honey of a Medical Device, not a Food, Drug or Cosmetic by Anthony Moloney http://www.ansongroup.com/its-a-honey-of-a-medical-device-not-a-food-drug-or-cosmetic/#comment-18 Anthony Moloney Sun, 20 Mar 2011 01:34:50 +0000 http://www.ansongroup.com/?p=270#comment-18 Yes an interesting question. As you correctly point out the principle question with respect to honey is "What is its primary mode of action?" and how does that relate to product claims. With respect to all honeys, the primary mode of action is honeys low pH and high osmolarity and the influence they have on the wound environment. While honeys are wonderfully complex in micro composition, the role of these other components, despite the hype is secondary in the context of wound management. Yes an interesting question. As you correctly point out the principle question with respect to honey is “What is its primary mode of action?” and how does that relate to product claims. With respect to all honeys, the primary mode of action is honeys low pH and high osmolarity and the influence they have on the wound environment. While honeys are wonderfully complex in micro composition, the role of these other components, despite the hype is secondary in the context of wound management.

]]> Comment on FDA Raises the Bar for Software Submissions by Tom Miller http://www.ansongroup.com/fda-raises-the-bar-for-software-submissions/#comment-5 Tom Miller Tue, 17 Aug 2010 22:00:17 +0000 http://blog.ansongroup.com/?p=33#comment-5 Excellent article. I would like to add that there is a point often misunderstood. FDA's graduated list of SW documents required for 510K submissions according devices of increasing Level of Concern does not imply that the manufacturer need only practice the design controls and SW processes needed to produce the required document package. On the contrary, they intend and expect that the manufacturer does all of them. The list specifies, for devices of each Level of Concern, what portion of the full device documentation set they wish to review in the 510K submission. Excellent article. I would like to add that there is a point often misunderstood. FDA’s graduated list of SW documents required for 510K submissions according devices of increasing Level of Concern does not imply that the manufacturer need only practice the design controls and SW processes needed to produce the required document package. On the contrary, they intend and expect that the manufacturer does all of them. The list specifies, for devices of each Level of Concern, what portion of the full device documentation set they wish to review in the 510K submission.

]]> Comment on iPhone App Predicate Strategy Flops by Jon Speer http://www.ansongroup.com/iphone-app-predicate-strategy-flops/#comment-10 Jon Speer Mon, 22 Mar 2010 16:12:40 +0000 http://blog.ansongroup.com/?p=121#comment-10 We've been paying attention to smart phone medical apps too: http://www.creoquality.com/creoBlog/cq/index.php?s=smart+phone. You should also check out http://www.medicalsmartphones.com/. I think it will be interesting to see how regulators get involved in this market. We’ve been paying attention to smart phone medical apps too: http://www.creoquality.com/creoBlog/cq/index.php?s=smart+phone.

You should also check out http://www.medicalsmartphones.com/.

I think it will be interesting to see how regulators get involved in this market.

]]> Comment on iPhone App Predicate Strategy Flops by Mark Cain http://www.ansongroup.com/iphone-app-predicate-strategy-flops/#comment-9 Mark Cain Thu, 18 Mar 2010 21:22:55 +0000 http://blog.ansongroup.com/?p=121#comment-9 To clarify, we have yet to begin the next round of clinical trials (for the PMA). We are working through the pre-IDE process with the FDA to determine the nature of the trials before they begin. -Mark Cain To clarify, we have yet to begin the next round of clinical trials (for the PMA). We are working through the pre-IDE process with the FDA to determine the nature of the trials before they begin.

-Mark Cain

]]> Comment on Colbie Caillat and Connected Health by Stephanie http://www.ansongroup.com/colbie-caillat-and-connected-health/#comment-8 Stephanie Wed, 03 Mar 2010 02:45:37 +0000 http://blog.ansongroup.com/?p=94#comment-8 Your daughter sounds like she has impeccable taste in music. That aside, I agree with your assessment. Even an avid concert attendee such as myself would be appalled to see money being used in such a way. Your daughter sounds like she has impeccable taste in music.

That aside, I agree with your assessment. Even an avid concert attendee such as myself would be appalled to see money being used in such a way.

]]> Comment on FDA Raises the Bar for Software Submissions by Laurie Foster http://www.ansongroup.com/fda-raises-the-bar-for-software-submissions/#comment-4 Laurie Foster Thu, 25 Feb 2010 18:02:25 +0000 http://blog.ansongroup.com/?p=33#comment-4 Great post. Very informative. Great post. Very informative.

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