The FDA has released a draft guidance: Unique Device Identifier Convenience Kit.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
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The CDRH issued the Procedures for Meetings of the Medical Devices Advisory Committee draft guidance on April 1, 2015. This draft guidance explains the processes for meetings of the Medical Devices Advisory Committee panels.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
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The FDA has issued a draft guidance document to provide information for low risk products that promote a healthy lifestyle.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
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance
The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices draft guidance has been released to communicate the FDA’s standpoint on enforcing regulatory controls in regards to digital health efforts. The FDA understands that medical device access to digital technology has the opportunity to create more efficient and improved patient care. This draft guidance discusses how … Read More
Balancing Premarket and Postmarket Data Collection
The FDA is working to make the premarket review process more efficient. This draft guidance explains how the FDA plans to balance premarket and post-market data collection while still maintaining a high standard of safety. Finding the right balance of data collection will provide patients with faster access to new technology without compromising device or patient safety. In some cases, the … Read More
Live Case Presentations
The FDA has released a draft guidance covering live case presentations during investigational device exemption (IDE) clinical trials. This draft guidance provides insight as to what should be provided in an IDE application regarding a live case presentation. A live case presentation is “the treatment of a human subject under the auspices of an approved or conditionally approved IDE, conducted and … Read More
Custom Device Exemption Draft Guidance
On January 14, 2014, FDA issued the draft guidance “Custom Device Exemption.” This document provides clarification about the custom device exemption from the Food and Drug Administration Safety and Innovation Act (FDASIA) and applies clarification to the custom device exemption contained in section 520(b) of the FD&C Act. “The new provision amended an existing custom device exemption and introduced new … Read More