July 2008: Recent Developments Relating to 513(g) Requests for Classification

January / February 2009: Imported Products-FDA Is Not Fooling Around

September 30, 2009: Firms Warn of Delays from FDA Scrutiny

December 30, 2009: Is the FDA Too Easy On Medical Devices?

January 11, 2010: State Marketing Laws Impacting Medical Device Manufacturers

August 2010: Plan of Action for Implementation of 510(k) and Science Recommendations

February 14, 2011: Device Recalls Blamed on Lax FDA Approval Path

February 14, 2011: FDA Regulatory Uncertainty Driving Jobs Overseas

February 16, 2011: BURR & COBURN: Caution kills

March 24, 2011: Letter to Industry about Import Entry Review Process

June 2, 2011: Documents for the June 2, 2011 Hearing, "FDA Medical Device Approval: Is there a better way?"

July 19, 2011: Analysis of Premarket Review Times Under the 510(k) Program

September 8, 2011: Paulsen on Job Crushing Medical Device Tax

October 31, 2011: Understanding Barriers to Medical Device Quality

December, 2011: Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information

December 27, 2011: Draft Guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

March 28, 2012: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

June 4, 2012: Scientific Disagreements Regarding Medical Device Regulatory Decisions

July 3, 2012: FDA proposes unique device identification system for medical devices

February 16, 2013: Small med-tech firms say FDA delays hurt innovationFDA proposes unique device identification system for medical devices

1600-G Golden Horseshoe Circle, Morrisville NC 27560

Tel: (919) 208-1953 Fax: (919) 249-8953

home | contact

November 2018. All rights reserved.