MEDICAL DEVICE AND DIAGNOSTICS
- OVERVIEW
- INSIGHTS
- NEWS & EVENTS
- PROFESSIONALS
RELATED BLOGS
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SERVICE AREAS
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RELATED PRACTICES
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RELATED INDUSTRIES
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REPRESENTATIVE CLIENTS
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Monsanto
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Nestle Purina Petcare
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Sigma-Aldrich
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University of Nebraska
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Our device and diagnostic clients vary in size based on revenues and business scope. We routinely advise these companies on device classification matters, filing for market clearance or approval, complying with both general and specific controls and market place liability issues, including products liability. Our representation extends to the new emerging market of mobile medical applications and the FDA’s regulation of these emerging device/diagnostics. We are advising clients on the new “GUDID” program the FDA has launched for medical devices, as well as on compliance with the medical device good manufacturing practice regulations.
Our counseling in this field includes:
- Filing both 510(k) and PMA Documents and obtaining clearance or approval to market
- Advising on compliance with Good Manufacturing Practices, as well as negotiating and drafting manufacturing agreements
- Negotiating global and regional licensing agreements for medical devices and in vitro diagnostics
- Advising on recalls
- Developing protocols on responding to inspections, as well as responding to issued 483 Inspection Reports
- Advising on record retention, tracing and tracking requirements
- Advising on the GUDID regulations for marking medical devices
- Advising on combination products with delivery systems
- Advising on the regulation of mobile medical applications, including FDA enforcement activities related to these applications
- Counseling on recalls for defective products
- Advising on FDA facility registrations
- Advising on supply chain and distribution issues
- Advising on import/export issues including tariffs and taxing
- Defending product liability litigation
- Advising on mergers and acquisitions, drafting of Private Placement Memorandas and acting as regulatory counsel on public offerings
We also advise a select group of our clients on the reprocessing of medical devices and the requirements related to the reprocessing and subsequent remarketing of reprocessed devices.
Publications
EEOC issues new guidance on COVID-19 vaccinations in the workplace
Litigation fees may be tax-deductible, confirms new Tax Court ruling
Participate in standard-setting bodies? The enforceability of your patents could be affected
Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers
What to do when the government comes calling: A checklist for handling facility inspections
USPTO launches new proof of use audit program
The shifting standard for IPR estoppel: Where are we now?
5 tips for environmental due diligence in business transactions
D.C. appellate court strikes another nail in the coffin for the Frye test
What U.S. companies need to know about their IP rights post-Brexit
New OSHA reporting and anti-retaliation rules
USPTO publishes new (and largely improved) guidance for subject matter eligibility
Federal Circuit rules objective prong of willful infringement best decided by judge
TCLE
Blog Posts
Clearview AI class-action may further test CCPA’s private right of action
‘Aggrieved Persons’ can bring suit under Biometric Information Privacy Act
DOJ continues to investigate, seek recoveries over compounding pharmacy fraud
Fate of legalized cannabis hinges on key vote
FDA to step up enforcement of homeopathic medicine
Recreational marijuana shake-up: Sessions revokes Cole Memorandum
Clinical trials Part I: The upcoming clinical trials reporting rule
The FDA's new Digital Health Plan
FDA’s Health Software PreCert Program to fast-track innovation
FSVP compliance dates arrive, challenges to food industry increase
News
ACI Drug and Medical Device Litigation Conference
Suzanne Galvin Quoted in Bloomberg Law Regarding Revised PFAS Settlement
World Trademark Review names Tom Polcyn to WTR 1000 list
Thompson Coburn releases 2021 Ag Innovation Survey on the impact of COVID, future of the ag industry
Jennifer Post talks to Business Insider about startup considerations before going public
Thompson Coburn supports agricultural growth through the Center for Soybean Innovation
Gain Executive Insights on trade developments with Thompson Coburn, Hispanic Chamber of Commerce
New Jersey jury awards $11 million to Thompson Coburn client in pet invention dispute
Agribusiness professionals enjoy hands-on farm simulation at Thompson Coburn
Thompson Coburn leads Missouri Soybean Merchandising Council to $600,000 jury verdict
Thompson Coburn earns corporate counsel recommendations five years running in national report
UMSL Research & Innovation Week to feature Tom Schlafly presentation
Steve Ritchey publishes article on patent basics for American Ceramic Society
Jeff Masson named ‘Influential Appellate Advocate’ for Monsanto Supreme Court win
Three partners named 2013 Up & Coming attorneys
Monsanto wins unanimous ruling from U.S. Supreme Court
19 Thompson Coburn partners named 2013 St. Louis Lawyers of the Year
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