Key Abbreviations
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Medical Devices and In Vitro Diagnostics (IVDs) -- Presentations
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Medical Devices and In Vitro Diagnostics (IVDs) -- Articles
The “De Novo” 510(k) Process and the Reclassification of Class III Devices.
Breakfast Briefing on Current FDA Issues.  San Diego, California.
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FDA Call for Data on non-PMA Class III Devices - Key Points To Consider.  Weinberg
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.

Regulatory Considerations for Medical Device Firms.  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.  IVT Medical Device Conference, August 15-17, 2006, San

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 – A Review of Key Provisions. OCRA Program on MDUFMA, December
2002, Irvine, CA.
Archives -- Medical Devices & IVDs
It’s The Law -- The “de Novo” 510(k) Process and the Reclassification of Class III
Devices. RAPS Focus 11(3), 32-34, 2006.
© 2014   Michael A. Swit.  


Contact me @ 760-815-4762
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.
Get to the Clinic on Time.  Regulatory/Reimbursement Panel.  The NIH-CAP
Commercialization Training Workshop.  November 10, 2014.  Los
[no slides]

Understanding FDA Regulation of Mobile Medical Applications.  RAPS Annual
Convention.  September 30, 2014, Austin, Texas.

Overview of FDA Regulation of Medical Devices.  DreamIt Philadelphia Healthcare
Companies.  Webinar.  August 11, 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,

The De Novo 510(k) Process.  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.

Creative Strategies in Dealing with FDA.  Compliance2Go. Webinar.  February 21, 2013.

The 510(k) Premarket Notification 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.
Michael A. Swit