Archives -- Medical Devices, IVDs, & Digital Health

Articles

Client Memorandum on FDA Regulation of Mobile Medical Applications.  Duane Morris.  November 2013.


FDA Final Guidance on Mobile Medical Applications. Client Alert. Duane Morris LLP.  October 4, 2013.


FDA Enforcement Action Against uChek: Does It Signal an Agency Wake-up Call for Non-compliant Mobile Medical Apps?  Duane Morris Client Alert.  June 2013.


"AliveCor Veterinary ECG Model Paves FDA-Friendly Path to the Market."  Duane Morris mHealth Newsletter, November 14, 2012.


De Novo Petitions -- 1998 to 2012 -- A Matrix of Approvals with Details on Special Controls. Compilation Accompanying FxConferences Webinar Presentation, February 15, 2012.


It’s The Law -- The “de Novo” 510(k) Process and the Reclassification of Class III Devices. RAPS Focus 11(3), 32-34, 2006. 


The “De Novo” 510(k) Process and the Reclassification of Class III Devices. Edited Transcript of Presentation of Michael A. Swit, Esq., at the November 2001 Breakfast Briefing on Current FDA Issues.  San Diego, California.

Presentations & Panel Discussions

 

Is a Quality Agreement Required for All  Suppliers?  Panel Discussion. 4th Annual ComplianceOnline Medical Device  Summit.  June 8, 2018.  San Francisco. [no slides; panelist]


Recent FDA Developments in Digital Health & Clinical Decision Support Software

4th Annual ComplianceOnline Medical Device Summit.  June 7, 2018.  San Francisco. 


EU MDR & IVDR Implications for Manufacturers & Suppliers.  Moderator, Panel Discussion, at MD&M West, February 7, 2018, Anaheim, CA.  [no slides; moderator]


Alternative Approaches to FDA Approval for Drug and Device Firms. Joint Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference. May 6, 2016. Irvine, CA.


FDA Regulation of Mobile Medical Applications. Joint Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference.  June 3, 2015. Irvine, CA.  


Alternative Approaches to FDA Approval for Drug and Device Firms. San Diego Regulatory Affairs Network. February 12, 2015. 


Alternative Approaches to FDA Approval for Drug and Device Firms. A Compliance2Go Webinar. January 29, 2015.   


FDA Trends in Medical Device Compliance.  Joint American Bar Association (ABA)/Medical Device Manufacturers Association (MDMA) Conference.  December 11, 2014. Washington, D.C. 


Mobile Medical Applications:  An Overview of FDA Regulation.  Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence Conference.  September 2014. Austin, Texas.


Overview of FDA Regulation (with a Medical Device Emphasis).  DreamIt Health Philadelphia 2014.  August 11, 2014.


The 510(k) Process. Compliance2Go Webinar.  January 29, 2014.


Digital Health and FDA.  Commercializing Software IP: High Tech, Digital Health & Education Conference. Jointly Sponsored by UCSF, UC Berkeley, and the LES Silicon Valley Chapter.  November 13, 2013.  Berkeley, CA.


Review of FDA’s Final Guidance on Mobile Medical Applications. DIA Annual Conference Program Committee Audio Conference. October 17, 2013.  [no slides]


Creative Strategies in Dealing With FDA.  PSC Creative Learning Webinar.  July 10, 2013.


An Overview of The “De Novo” Process – Reclassifying Devices Automatically Placed Into Class III.  DIA Annual Conference.  June 26, 2013. Boston. 


Regulatory Convergence:  Impact of FCC, HIPAA/Privacy and FDA on Mobile Health and Medical Devices. Fx Conferences Webinar.  May 21, 2013.


Alternative Approaches to FDA Approval for Drug and Device Firms.  Compliance2Go. Webinar. February 21, 2013.


Premarket Notification The 510(k) Process.  FDLI Introduction to Medical Devices Conference.  June 5, 2012, Palo Alto, CA.


The de novo 510(k) Process -- The Impact of the New 2011 FDA Guidance.  FxConferences Audio Conference.  February 15, 2012.


FDA Enforcement and Compliance.  Introduction to Medical Device Law. FDLI.  November 2010, Costa Mesa, CA. 


510(k) Process.  Panel Discussion at BayBio Breakfast Meeting.  May 11, 2010, Palo Alto, CA.  [panel; no slides]


FDA Call for Data on non-PMA Class III Devices - Key Points To Consider.  Weinberg Group Webinar, April 20, 2010. [no slides]


CAPA Program.  OCRA, March 10, 2010, Irvine, CA. [Moderator; no slides]


Overview of FDA Issues for Cardiovascular Devices.  Southern California Biotech Assn.  January 28, 2009, Laguna Hills, CA.


Overview of FDA Regulation of Devices & Diagnostics.  NIH-CAP Program. LARTA, February 12 and 13, 2008, via webinar.


Alternative Approaches to Device Approvals.  SDRAN, November 28, 2006, San Diego.


Key Considerations in Developing Clinical Protocols for U.S. and EU Approval. IVT Medical Device Conference, August 15-17, 2006, San Francisco.


Medical Device Advertising Law & Regulation.  IVT Medical Device Conference, August 15-17, 2006, San Francisco.


Problems Faced by Device Companies in Navigating FDA Promotional Issues.  Panel Discussion at the Wilson Sonsini Goodrich & Rosati Medical Device Conference, June 15, 2006, San Jose, CA.  [panel; no slides]


Using Clinical Studies to Support Claims for 510(k) Devices.  RAPS Advertising, Promotion and Labeling Conference, May 2, 2006, Denver.


The “De Novo” 510(k) Process and the Reclassification of Class III Devices.  510(k) Workshop,  Medical Device Manufacturers Association, October 1, 2005, Boston.


MDUFMA – Overview of Key Provisions. OCRA Program on MDUFMA, December 2002, Irvine, CA. 

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