Medical Device Associations
Massachusetts Medical Device Industry Council (MassMedic)
The 510K Process: Best Practices in Changing Times, April 1, 2010
Sullivan T (Vice President, Regulatory Affairs ACMI/Gyrus). 510(k) Strategies – CDRH (ppt)
Finneran S (Director of Clinical & Regulatory Affairs Haemonetics Corporation). 510(k) Strategies – CBER (ppt)
Kim PT (Partner, Foley Hoag, LLP). What FDA & Congress Are Planning for the 510(k) Program (ppt)
MassMEDIC FDA Update Conference, December 1, 2010
Announcements
14 Senators Sign Letter to FDA Commissioner Urging Caution on 510(K) Revisions (pdf)
Massachusetts Medical Devices Journal (MassDevice)
UPDATE: Industry reacts to proposed changes to 510(K) program (Aug 4, 2010)
FDA announces 510(k) changes (Jan 19, 2011)
Advanced Medical Technology Association (AdvaMed)
Conferences
Tseng E (King & Spaulding, LLP). Reconsidering 510(k): Reform or Ruin? (ppt)
White Paper
Battelle Institute: 510(k) Premarket Notification Evaluation (pdf)
EU Medical Device Approval Safety Assessment (Boston Consulting Group - BCG), Jan 2011 (pdf)
Announcements
AdvaMed Statement on IOM 510(k) Report, July 29, 2011
Medical Device Manufacturers Association (MDMA)
California Healthcare Institute (CHI)
Sponsored Studies
Makower J, Meer A, Denend L. FDA Impact on Medical Technology Innovation - A Survey of Over 200 Medical Technology Companies. November 2010. Slide Deck
Announcements
MDMA Statement on IOM's 510(k) Report, July 29, 2011
Medical Device Consultants, Inc. (MDCI)
Presentations
Publications
Robinson R. Back to Basics Strategies for Dealing with 510(k) Uncertainty (Consultants Corner Electronic Newsletter, May 2010)
Andrews R, Robinson R. Regulatory Outlook - Device Approval 101 (MD&DI, July 2009)
Robinson R. The FDA Amendmants of 2007 - More than Just Medical Device User Fees, (Journal of Medical Device Regulation, 2008, 5(1), 39-49) (pdf)
Robinson R. US FDA Regulations of Combination Products, (Journal of Medical Device Regulation, 2005, 2(4), 1) (pdf)
Robinson R. CDRH Third Party Review Process, (Journal of Medical Device Regulation, February 2005) (pdf)
Robinson R. Nonclinical Development Activities for Medical Devices (Regulatory Affairs Focus, July 2004) (pdf)
Robinson R, Hemeon-Heyer S. Preparing a Successful 510(k) Submission, Part 1 of 2, Medical Product Outsourcing, March/April 2004 (pdf)
American Enterprise Institute for Public Policy Research (AEI)
Regulation and Reimbursement for Medical Devices: Protecting Public Health while Fostering Innovation, November 5, 2010
White papers
Miscellaneous
California Healthcare Institute
Congressional Medical Technology Caucus to FDA, letter to Margaret Hamburg, Nov 3, 2011
Clinical Device Group
Stark NJ, Johnson K. CDRH's 510(k) Working Group Preliminary Report; TAKE THE 510(K) REVIEWER SURVEY A Cycle of Whitepapers Oct 29, 2010
CDRH's 510(k) Working Group—Findings 1 & 2; A GLIMPSE OF THE FUTURE?, Nov 7, 2010
CDRH's 510(k) Working Group—Findings 3 & 4a, Nov 20, 2010
CDRH's 510(k) Working Group—Finding 4; A GLIMPSE OF THE FUTURE? Nov 28, 2010
Device Watch
Smith j, Barrett S. What are 510(k) Clearance and Premarket Approval?, April 2008
Overview of FDA's Device Regulation, April 2003
Emergo Group
GlobalData
Health Decisions
LifeScience Alley (LSA)
LSA / FDA Engagement Summary Meeting, August 2, 2011 (video)