The FDA has released a draft guidance: Unique Device Identifier Convenience Kit. This document further explains the phrase “convenience kit” and how it applies to the UDI rule. The FDA released their final rule for UDI on September 24, 2013, requiring most medical devices to label a UDI. The UDI will have many benefits such as improved product information and … Read More
eCopy Program for Medical Device Submissions
Certain medical devices must provide an electronic copy (eCopy) of their submission. An eCopy is a duplicate of the paper copy that is submitted to the FDA, and may be submitted on a CD, DVD, or flash drive. The purpose of an eCopy is to improve the review process by making a submission available immediately. The updated guidance document “eCopy Program for Medical Device Submissions” was … Read More
Unique Device Identification: Direct Marking of Devices – Draft Guidance Overview
The Unique Device Identification: Direct Marking of Devices draft guidance has been released by the FDA. A UDI is required to be directly marked onto a device if it is “intended to be used more than once and reprocessed before each use.” (FDA) Directly marking a UDI on reprocessed devices helps to maintain accurate information and keeps the UDI in contact with … Read More
Procedures for Meetings of the Medical Devices Advisory Committee
The CDRH issued the Procedures for Meetings of the Medical Devices Advisory Committee draft guidance on April 1, 2015. This draft guidance explains the processes for meetings of the Medical Devices Advisory Committee panels. Panel meetings provide an opportunity for addressing scientific, clinical, or public health issues. Medical Device Advisory Committee Panels functions: Panels may give expertise for medical device premarket submissions … Read More
MDDS, Medical Image Storage Devices, & Medical Image Communications Devices Final Guidance
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 A draft guidance regarding MDDS was issued on … Read More
General Wellness: Policy for Low Risk Devices
The FDA has issued a draft guidance document to provide information for low risk products that promote a healthy lifestyle. CDRH defines general wellness products as products that “are intended for only general wellness use, and present a very low risk to users’ safety.” A general wellness product must either help to maintain a general state of health, or help to reduce the risk or … Read More