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MEDICAL DEVICE AND DIAGNOSTICS

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

Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers

Supreme Court heralds tectonic shift in venue selection for patent suits

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

Supreme Court comments on patentable subject matter in Prometheus decision

Blog Posts

FSVP compliance dates arrive, challenges to food industry increase

Interpreting the renewed Rohrabacher-Farr Amendment: A loophole for enforcement?

Privacy and the Internet of Medical Things: What’s a curmudgeon to do?

FDA sanitary transport rule impacts railroads, other shippers

University patents now immune to inter partes review: Will business come calling?

Food industry sees one of first whistleblower suits under FSMA

Update: GMO labeling regs are back in limbo

FDA bans powdered gloves in human, animal medicine

What the FDA has in store for the food industry in 2017

Cannabis in animal supplements: A hazy proposition

TCLE

Statutory Changes, New Regulations, and Compliance Deadlines Under the Food Safety Modernization Act

Survival Tools to Protect Biotechnological Innovation

News

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

Betsy Haanes authors chapter on IP asset protection strategy

Jason Schwent, Kelly Simon named 2014 Up & Coming attorneys

Betsy Haanes co-authors article on obviousness-type double patenting

Thompson Coburn sponsors St. Louis ‘Inventor of the Year’ awards celebration

Jim Slear leads webinar on ‘Navigating the Russian and Ukrainian Sanctions Maze’

UMSL Research & Innovation Week to feature Tom Schlafly presentation

Steve Ritchey publishes article on patent basics for American Ceramic Society

Dr. Betsy Haanes joins Thompson Coburn as a partner

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

Jason Schwent publishes article in Bloomberg BNA patent journal

19 Thompson Coburn partners named 2013 St. Louis Lawyers of the Year

102 Thompson Coburn attorneys featured in 2013 Best Lawyers list

Jeff Masson featured in AgProfessional magazine

Mizzou forums feature Thompson Coburn partners

Senator Kit Bond to kick off Missouri Technology Expo

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Matt Braunel
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Betsy Haanes, Ph.D.
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Jeff Masson
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Jonathan Musch
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