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 This draft guidance explains how the FDA plans to balance premarket and post-market data collection while still maintaining a high standard of safety.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The FDA has released a draft guidance covering live case presentations during investigational device exemption (IDE) clinical trials. This draft guidance provides insight as to what should be provided in an IDE application regarding a live case presentation.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
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
FMDIC Workshop
The FDA Medical Device Industry Coalition is presenting a public workshop this Friday, April 11, 2014 in Dallas, Texas. OMEDtech is a member of FMDIC and will be representing OKBio at this workshop. This workshop, “Medical Devices – the Case for Quality,” will gather input from those in the medical device industry about how to improve quality practices. Click here … Read More
Export Certificates and CDRH
The CDRH has released a letter stating that as of March 1, 2014 they will no longer be notarizing FDA CDRH export certificates. The FDA is not under any obligation to provide this service but they have been fulfilling this role. These notarized documents from the FDA have been official and have needed no further action for verification. If you … Read More
UDI Update
The first deadline for the UDI rule is approaching. The FDA released their final rule for UDI on September 20, 2013. Most medical devices will require a UDI or Universal Device Identifier within the next seven years. The UDI will have many benefits such as improved product information and faster product identification for problems or recalls. The following timeline shows … Read More
Apple Working with FDA on Mobile Medical Apps
Apple has been working on mobile medical apps.Executives from Apple and the FDA met in December to discuss mobile medical apps. Some of the executives from Apple were: Jeff Williams (senior vice president of operations), Bud Tribble (vice president of software technology), and Michael O’Reilly (who has a background in medical devices as the former chief medical officer of Masimo Corporation). … Read More
CDRH Releases New Strategic Priorities for 2014
The CDRH has released their new strategic priorities for 2014. They will focus on three different areas of improvement with specific goals and deadlines for each area. Their overall goal is for patients to have access to safe and effective medical devices as soon as possible. To accomplish this goal they are looking to make improvements that would encourage medical … Read More