FDA draft guidance released There are many reasons why a sponsor may want to conduct a clinical trial Outside of the United States (OUS).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
We have been recently getting a lot of queries whether or not FDA can still issue NDC/NHRIC labeler codes for medical devices with the recent advent of the new UDI (Unique Device Identification) regulations being implemented by the FDA. The answer to this question is NO!!! Some of the clients are arguing about the NDC
Clients, please be aware of the final release of the guidance document for reprocessing of medical devices. Earlier this month news came out of a fatal bacterial infection at UCLA Medical Center. The infection was spread by an endoscope, a type of reusable medical device. This sparked discussion around the topic of what role the
The Problem and Attorney General’s statement: It was found out that DNA barcoding tests commissioned by attorney general’s office on six popular herbal supplements found that of hundreds of bottles tested, 4 out of 5 contained none of the herbs listed on the labels. The supplements included ginseng, touted as an energy booster; Echinacea, marketed
Whether you watched the international consumer electronics show this year or not, it’s hard not to notice the plethora of devices used to monitor health and wellbeing. However, are these devices considered products from the perspective of the FDA and thus are subject to regulation? Well, it all comes down to what the product claims
Accessories to medical devices, what are they and how does FDA regulate them? FDA released a draft guidance document to address just this question. As with all draft guidance’s, it is currently open for comment, details on how to submit comments are provided at the end of this update. FDA defines an accessory to be
What is the guidance about? The guidance addresses general considerations for CGMP requirements for combination products and the purpose and content of specific CGMP provisions addressed in 21 CFR part 4. The guidance also contains hypothetical scenarios intended to clarify how to comply with certain CGMP requirements addressed in part 4 by presenting compliance considerations
Overseas Industry Links The list below is meant to be a comprehensive list of important overseas industry links that are helpful and useful for our clients. Click the title to go to the links. If you find a useful link that would be helpful to others, please email it to us (contact page), and we
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