Lessons From FDA Draft Guidance On Multifunctional Devices

By Gregory Levine and Abram Barth (May 23, 2018, 1:58 PM EDT) -- On April 27, 2018, the U.S. Food and Drug Administration issued draft guidance on the regulation of devices with multiple functions. The draft guidance implements a requirement of the 21st Century Cures Act, signed into law on Dec. 13, 2016, prohibiting FDA from directly regulating non-"device" software functions in digital health products. The FDA did not limit the scope of the draft guidance to cover only the Cures Act mandate, however. Instead, the draft guidance addresses any type of product that includes both device and other functions, regardless of whether those functions involve software. Therefore, any manufacturer of a product that includes both FDA-regulated device functions and non-FDA-regulated functions should be familiar with the draft guidance....

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!


Attached Documents

Related Sections

Law Firms

Government Agencies

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!