Firm Wire items are announcements made by the firms themselves. The desk confirms that the announcement was published and reproduces its factual content. It does not verify the claims in it, and publication is not an endorsement.
Foley publishes US medical device market entry overview
Foley & Lardner published an overview of regulatory considerations for medical device companies entering the United States. The firm’s article organized the discussion around the product lifecycle, connecting premarket review with obligations that continue after a device reaches customers and with commercial planning.
Key points
- Foley identified David L. Rosen, William E. Holtz and Jessa Boubker as authors.Foley & Lardner
- The publication compared classification, 510(k), premarket approval and De Novo pathways.Foley & Lardner
- Foley’s article covered quality systems, establishment registration and unique device identification.Foley & Lardner
- The overview also discussed postmarket responsibilities and reimbursement considerations.Foley & Lardner