The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance has been released. The FDA posted a regulation down-classifying Medical Device Data Systems (MDDS) from Class III to Class I on February 15, 2011. Class I devices are subject to general controls under the FD&C Act. A draft guidance regarding MDDS was issued on … Read More
Medical Device Recall vs. Enhancement
The Distinguishing Medical Device Recalls from Medical Device Enhancements guidance addresses questions and inconsistencies that arise when making changes to a marketed device. When determining whether a change to a device is classified as a recall or enhancement, you should always carefully review all appropriate regulations. The FDA defines a medical device recall as “a firm’s removal or correction of … Read More
Communication During FDA Review of Medical Device Submissions
The FDA’s current views on communication during the review of medical device submissions can be found in the Types of Communication During the Review of Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff. This guidance proposes improvements for the review process, including four types of communication. 1. Acceptance Review Communication Purpose: This type of communication … Read More
FDA Final Guidance on Mobile Medical Apps
Mobile Medical Applications The number of mobile applications and users are growing every day. Included in this expanding technology is the category of mobile medical applications. “Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated … Read More
UDI Final Rule
UDI Final Rule The FDA released their final rule for UDI on September 20, 2013. Most medical devices will require a UDI or Universal Device Identifier. The UDI will have many benefits such as improved product information and faster product identification for problems or recalls. The UDI is a unique code made up of two parts. The DI is the … Read More
MDUFA III Guidance Documents Final Release
FDA released three MDUFA III guidance documents on 12/31/2012. Happy New Year! The guidance documents discuss key provisions of MDUFA III. The guidances are on the eCopy program, Premarket Approval Applications and 510(k) files acceptance criteria. For a little light reading, check out this link.