Home > Services > Life Sciences and Biotechnology > Medical Device and Diagnostics

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.

Blog Posts

DOJ continues to investigate, seek recoveries over compounding pharmacy fraud

Connected medical device vulnerabilities continue to impact manufacturers, health care

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

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

Publications

Criminal antitrust prosecutions still loom for employers with ‘no-poaching,’ ‘wage-fixing’ agreements

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

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

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

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

Partner
St. Louis
314 552 6003

Gordon is a highly experienced trial attorney who has achieved significant courtroom wins for clients in cases involving commercial disputes, white collar criminal defens...

Gordon is a highly experienced trial attorney who has achieved significant ...

Gordon Ankney
Partner
St. Louis
314 552 6408

Matt represents major agricultural companies in business-critical disputes involving technology licensing, distribution channels, grain channeling, genetic testing, and p...

Matt represents major agricultural companies in business-critical disputes ...

Matt Bober
Partner
St. Louis
314 552 6546

Senator Bond draws on his distinguished record of public service to represent clients on matters related to international trade, economic development, biotechnology, agri...

Senator Bond draws on his distinguished record of public service to represe...

Kit Bond
Partner
St. Louis
314 552 6106

Matt litigates all forms of intellectual property.

Matt litigates all forms of intellectual property.

Matt Braunel
Partner
St. Louis
314 552 6139

Dan handles various types of complex litigation, including business, tort, product liability, intellectual property, and class action defense.

Dan handles various types of complex litigation, including business, tort, ...

Dan Cox
Senior Patent Agent
St. Louis
314 552 6348

Wendy focuses her work with Firm clients on patent prosecution in biotechnology and life sciences, especially in the fields of plant genetics and plant biochemistry.

Wendy focuses her work with Firm clients on patent prosecution in biotechno...

Wendy Davis, Ph.D.
Partner
St. Louis
314 552 6528

Chip's practice focuses on the representation of individuals, universities, and national and international companies in commercial transactions and counseling involving t...

Chip's practice focuses on the representation of individuals, universities,...

Chip Fendell
Partner
St. Louis
314 552 6512

Wil has a PhD in cellular and molecular biology and experience as research scientist working for a major biotechnology company.

Wil has a PhD in cellular and molecular biology and experience as research ...

Wil Holtz, Ph.D.
Partner
St. Louis
314 552 6485

Benjamin is a corporate advisor and business strategist for a wide variety of privately-held businesses, manufacturers, financial institutions, and nonprofits.

Benjamin is a corporate advisor and business strategist for a wide variety ...

Benjamin Hulsey
Partner
St. Louis
314 552 6304

David strategically advises clients in a variety of intellectual property disputes including patent prosecution, IP litigation, Post-Grant Proceedings, trademark, non-inf...

David strategically advises clients in a variety of intellectual property d...

David Jinkins
Partner
St. Louis
314 552 6072

Tom is a veteran M&A and corporate finance attorney who provides clients with common-sense solutions to address complex transactional issues.

Tom is a veteran M&A and corporate finance attorney who provides client...

Tom Litz
Partner
St. Louis
314 552 6429

Jeff is a litigator and ag insider who works with the country's largest agribusinesses to develop effective litigation strategies on a national and global scale.

Jeff is a litigator and ag insider who works with the country's largest agr...

Jeff Masson
Partner
St. Louis
314 552 6547

Jonathan's practice includes nearly every aspect of intellectual property litigation.

Jonathan's practice includes nearly every aspect of intellectual property l...

Jonathan Musch
Partner
St. Louis
314 552 6190

Chris is a valued strategic partner to emerging companies and the institutions and individuals that invest in them.

Chris is a valued strategic partner to emerging companies and the instituti...

Chris Reid
Partner
St. Louis
314 552 6232

Steve advises clients on domestic and international patent applications and provides comprehensive counsel on licensing and technology transfer.

Steve advises clients on domestic and international patent applications and...

Steve Ritchey
Senior Patent Agent
St. Louis
314 552 6255

Charley draws on his 14 years of biotech industry experience and doctorate in biochemistry to serve clients in the biotech industry and university sectors.

Charley draws on his 14 years of biotech industry experience and docto...

Charley Romano, Ph.D.
Partner
Chicago
312 580 2224

Diane helps life sciences companies develop new products and bring them to market while proactively addressing the regulatory land mines that can delay or destroy the pat...

Diane helps life sciences companies develop new products and bring them to ...

Diane Romza-Kutz
Partner
St. Louis
314 552 6352

Ben brings a background in electrical and computer engineering to his legal practice, which primarily focuses on the preparation and prosecution of patent applications.

Ben brings a background in electrical and computer engineering to his legal...

Ben Volk, Jr.