The FDA new user fees for Fiscal Year 2016 (October 1, 2015 through September 30, 2016) are as follows: FY16 User Fees (in U.S. Dollars) Application Type Standard Fee Small Business Fee 510(k)‡ $5,228 $2,614 513(g) $3,529 $1,765 PMA, PDP, PMR, BLA $261,388 $65,347 panel-track supplement $196,041 $49,010 180-day supplement $39,208 $9,802 real-time supplement $18,297
Clients are being made aware of this new milestone development for the first time in the FDA’s history, through which FDA is establishing an advisory committee focused on patient engagement. The Patient Engagement Advisory Committee will provide advice on complex issues relating to medical devices, the regulation of devices, and their use by patients to
Starting Sept 2016 All our food clients are made aware that the FDA has finally released the final rules on two regulations that will affect the human and animal foods. These changes will be the most comprehensive and dynamic changes to the Food Industry since the 1970’s. The intent is to provide new Safety Requirements
NEWS FLASH!!! For those of those that ship FDA regulated devices out of the country we are familiar with export certificates. FDA has revised the payment requirements for export certificates, the fees are now: Original Certificates: $175 Subsequent Certificates issued for the same product(s): $85 The maximum number of pages for a certificate is now
The clients are being made aware of the recent guidance that FDA released on its current thinking on defining accessories classification pathway for new accessories and has opened it for comment. FDA defines accessory as a device that is intended to support, supplement, and/or augment the performance of one or more parent devices. A parent
Clients are being made aware of an important development from the FDA with regards to the 510(k) submission process. A revised version of the guidance document “Refuse to Accept Policy for 510(k)’s” will go into effect October 1st, 2015. FDA revised this guidance with the purpose of describing the 510(k) Refuse to Accept (RTA) process
NEWS FLASH!!! The FDA has rethought their decision on re-classifying Clinical Electronic Thermometers to 510(k) exempt. mdi was part of the this process for the FDA to re-evaluate this decision. The FDA’s decision of making such an important clinical monitoring device to be marketed without FDA 510(k) clearance was “just not a good idea” and
Gowns intended for use in healthcare settings must adequately provide a liquid barrier. This draft guidance provides FDA’s current thinking on the regulatory requirements and performance testing needed to support liquid barrier claims for gowns. Gowns can make two claims to barrier protection Minimal or Low Barrier protection: a. ANSI/AAMI PB70 Level 1 protection
FDA released this draft guidance to provide its current thinking on direct marking of devices in regards to UDI requirements. For devices that are intended to be used more than once and reprocessed before each use, they must bear a UDI on the device itself if it is also are required to have a UDI
FDA requires an IDE prior to a sponsor initiating a clinical investigation for devices which FDA has determined to be Significant Risk. Through the IDE, the sponsor must demonstrate how the risks to the subjects are not outweighed by the anticipated benefits. If FDA is unable to determine that the benefits to the patients are
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