Medical Device Associations

Massachusetts Medical Device Industry Council (MassMedic)

The 510K Process: Best Practices in Changing Times, April 1, 2010

Robinson R (Principal Consultant, Regulatory Services MDCI). Changes in the 510(k) Process – An Overview (ppt)
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


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)


AdvaMed BioCom DeviceFest Conference, April 14,2010
Tseng E (King & Spaulding, LLP). Reconsidering 510(k):  Reform or Ruin? (ppt)

White Paper


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


MDMA Statement on IOM's 510(k) Report, July 29, 2011

Medical Device Consultants, Inc. (MDCI)



Robinson R. Transparency or Exposure in the USA - It Depends on Which Side of the Window You’re On  (Aug 2010) (pdf)
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. FDA Regulations for Medical Devices (CABA, Boston, June 2009) (pdf)
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)
Robinson R, Hemeon-Heyer S. Abbreviated and Special 510(k)s, Part 2 of 2,  Medical Product Outsourcing, May 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


Device Watch

Emergo Group