Tag Archives: EMR
August 14, 2012 by Allison Scott
New Draft FDA Guidance: Refuse to Accept Policy for 510(k) Submissions
On August 13, 2012, FDA issued a draft guidance document that, when final, will superseded the existing “Refuse to Accept” guidance document. The updated draft policy includes an early review against specific acceptance criteria and to inform the submitter within the …
August 14, 2012 by Allison Scott
FDA Issues Draft Pre-Submission Guidance; Includes Pre-510(k) Program
On July 13, 2012, FDA issued a draft guidance document regarding pre-submission interactions with the Agency. This draft guidance will eventually supersede the March 1999, Blue Book Memorandum Pre-IDE Program: Issues and Answers. The Pre-IDE program has since evolved into …
August 6, 2012 by Allison Scott
FDA Withdraws 2011 Deciding When Guidance
On July 17, 2012, FDA withdrew the 2011 Draft Guidance for Industry and FDA Staff – 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device. This was done in accordance with Section 510(n)(2)(B) …
August 6, 2012 by Allison Scott
FDA’s UDI Proposed Rule 2012
Scott Thiel of Anson has provided the following summary of FDA’s newly released proposed rule for a UDI system. The concept for the system has been under development by FDA for several years and after several public interactions with Industry …
August 3, 2012 by Allison Scott
Remote Patient Monitoring Market to increase over $20B
A recent report estimates that the remote patient monitoring market will increase to over $20 Billion dollars by 2016 – that’s more than double what the market is today ($8.9B). Just in the last couple of years Anson has seen …
July 31, 2012 by Allison Scott
Would FDA agree with you?
The publication McKensey Quarterly for June 2012 “Why good companies create bad regulatory strategies” raises this same question. Most corporate executives would agree that having an effective regulatory strategy is important. However, what most companies are overlooking is the effect …
June 11, 2012 by Dane Stout
Human Factors Engineering: Bringing iPhone usability to medtech
A team of my fellow consultants from Anson and I participated in a webcast session sponsored by RAPS last week on the highly critical topic of Human Factors in Medical Device Development. The information presented, particularly a presentation by Dr. Molly …
March 12, 2012 by Dane Stout
Building the Cathedral of Personalized Medicine One Sample at a Time
Anson’s culture is one that puts high value and importance on giving back to the community and society as part of measuring its value return on business. Anson employees are encouraged to give back to the community, and even have …
March 9, 2012 by Dane Stout
Anson Group is a Proud Sponsor of Kids Against Hunger
Did you know that every 6 seconds a child dies from hunger related disease? Anson is proud to be a corporate sponsor for the first ever Zionsville area Kids Against Hunger packing event on March 10, 2012. If you’re not …
