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[To view/download the full text of a presentation or article, just click on the title below.]
Medical Device and In Vitro Diagnostics (IVDs) -- Presentations
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Medical Device and In Vitro Diagnostics (IVDs) -- Articles
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.
Edited Transcript of Presentation of Michael A. Swit, Esq., at the November 2001
Breakfast Briefing on Current FDA Issues. San Diego, California.
For information on the Services we
provide relating to Medical Devices
provide relating to Medical Devices
Overview of FDA Issues for In-Vitro Diagnostics. Southern California Biotech Assn.
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.
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 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 – A Review of Key Provisions. OCRA Program on MDUFMA, December
2002, Irvine, 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.
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 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 – A Review of Key Provisions. OCRA Program on MDUFMA, December
2002, Irvine, CA.
| Speeches & Articles Archives |
It’s The Law -- The “de Novo” 510(k) Process and the Reclassification of Class III
Devices. RAPS Focus 11(3), 32-34, 2006.
Devices. RAPS Focus 11(3), 32-34, 2006.
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De Novo Petitions -- 1998 to 2011 -- A Matrix of Approvals with Details on Special
Controls. Compilation Accompanying FxConferences Webinar Presentation, February
15, 2012.
Controls. Compilation Accompanying FxConferences Webinar Presentation, February
15, 2012.
The de novo 510(k) Process -- The Impact of the New 2011 FDA Guidance.
FxConferences Audio Conference. February 15, 2012.
De Novo Petitions -- 1998 to 2011 -- A Matrix of Approvals with Details on Special
Controls. Compilation Accompanying FxConferences Webinar Presentation,
February 15, 2012.
FxConferences Audio Conference. February 15, 2012.
De Novo Petitions -- 1998 to 2011 -- A Matrix of Approvals with Details on Special
Controls. Compilation Accompanying FxConferences Webinar Presentation,
February 15, 2012.
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