Followers | 913 |
Posts | 4481 |
Boards Moderated | 0 |
Alias Born | 03/26/2018 |
Tuesday, October 16, 2018 10:56:33 AM
Vivos FDA Lawyer John J. Smith, M.D., J.D. Hogan Lovells: Global Lawyers - International Law Firm
Vivos has many aces up its sleeve to succeed..
As both a physician and a lawyer, John Smith combines clinical and regulatory experience relating to the Food and Drug Administration (FDA) with a practical approach to addressing the FDA regulatory issues facing his clients. He places a particular focus on bringing device-based technologies to market.
A board-certified diagnostic radiologist and former associate professor of radiology at Harvard Medical School, John joined the Hogan Lovells Medical Device Group in 2005. Since then, he has assisted clients in a range of FDA premarket submissions, including 510(k) notices, de novo reclassification petitions, humanitarian device exemption applications, and premarket approval applications, including the advisory panel process.
John identifies successful regulatory strategies and presents them to the FDA via the pre-submission process; he assists with problem submissions through submission-issue meetings and administrative appeals. He also navigates the increasingly challenging FDA compliance landscape, addressing 483 and Warning Letter issues.
Bringing new products to the U.S. market is continually complex and demanding. Having worked in the medical device area in academia, industry, and at Hogan Lovells, John understands how to address both pre- and postmarket FDA regulatory issues. His practical approach has guided clients through successful marketing applications, addressed significant differences of opinion with the FDA through submission-issue meetings and regulatory appeals, and provided crucial support through challenging FDA enforcement actions.
To serve his clients, John draws on the broad experience and skills of his colleagues in the Medical Device Group and effectively communicates with reviewers and decision makers at the FDA. A Super Lawyers designee for multiple years, John is a leader in the medical device bar and well known to the FDA.
$RDGL
Recent RDGL News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 06:28:50 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 09:30:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 09:40:48 PM
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 12/07/2023 05:15:10 AM
- Form 1-A POS - • Edgar (US Regulatory) • 11/27/2023 10:29:12 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/06/2023 04:28:46 PM
- Form 1-A POS - • Edgar (US Regulatory) • 11/03/2023 09:03:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/19/2023 04:18:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/11/2023 10:33:58 AM
- Form 1-A POS - • Edgar (US Regulatory) • 10/10/2023 04:05:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/04/2023 07:22:21 PM
FEATURED POET Wins "Best Optical AI Solution" in 2024 AI Breakthrough Awards Program • Jun 26, 2024 10:09 AM
HealthLynked Promotes Bill Crupi to Chief Operating Officer • HLYK • Jun 26, 2024 8:00 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM