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 This draft guidance provides FDA’s current thinking on the regulatory requirements and performance testing needed to support liquid barrier claims for gowns.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FDA released this draft guidance to provide its current thinking on direct marking of devices in regards to UDI requirements.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
New FDA Update!!! Over the next two years FDA may require all new drug and biologic submissions to be sent electronically. FDA will adhere to the International Conference on Harmonization’s (ICH) electronic common technical document (eCTD) format. Adoption of this format will allow companies to submit an application for a new pharmaceutical or biological product
On April 20th of this year two senators from Maine and California introduced the Personal Care Products Safety Act . If passed, this bill would expand FDA’s authority over cosmetic products sold in the United States. The changes are similar to that of requirements for nonprescription drugs including cosmetic GMP’s and ingredient review, establishment and
FDA draft guidance released There are many reasons why a sponsor may want to conduct a clinical trial Outside of the United States (OUS). Question is, will FDA accept this data to support marketing the device in the U.S.? Short answer, yes – provided certain conditions are met. For a PMA, under 21 CFR 814.15(b),
PILOT PROGRAM FDA is accepting requests starting May 1st to May 31st 2015 for participation in their pilot program for electronic submission of home use device labeling. The labelling, including safety information and instructions for use, will be submitted through the registration and listing database. This database will be available to patients, caregivers, and the
As part of the EAP program, FDA intends to provide more interactive communications during device development and more interactive review of Investigational Device Exemption applications, PMA applications, and requests for de novo review. This includes working with the sponsor to create a data development plan specific to the device, which would outline all data the
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