FDA finalizes regulation for certain software, hardware used with medical devices

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA finalizes regulation for certain software, hardware used with medical devices

FDA finalizes regulation for certain software, hardware used with medical devices
Mon, 14 Feb 2011 11:13:00 -0600

Today, the FDA issued a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

---

Manage your FDA Subscriptions:

• Update your preferences or unsubscribe
• Questions about this service? support@xxxxxxxxxxxxxxx
• Other inquiries? webmail@xxxxxxxxxx

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420