FDA's Strategy For Interoperable Medical Device Regulation

Law360, New York (February 4, 2016, 12:15 PM EST) -- Mark Mansour

Angela E. Giancarlo

Christopher M. Mikson This week, the Food and Drug Administration issued draft guidance entitled Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices. The FDA issues such documents to provide the agency's "current thinking" on a matter of concern to regulators and stakeholders. This particular guidance provides FDA's views on issues that device makers should consider when designing interoperable medical devices. In addition, FDA's draft guidance discusses how device makers should prepare a premarket submission, which is a form of application for permission to market a medical device. Many companies are likely to take an...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!