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 FDA released a draft guidance document to address just this question. As with all draft guidance’s, it is currently open for comment, details on how to submit comments are provided at the end of this update.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
Background: Parnell, former chief executive of the now-defunct company with plants in three states producing peanut butter and peanut paste used for its own products and as an ingredient in almost 4,000 others, was convicted by the 12-member jury for his role in a deadly Salmonella outbreak that began almost six years ago. The government
Clients are being notified of a recent development from the Notified Body BSI that it will be increasing the number of unannounced ISO audits for high-risk devices or for noncompliant manufacturers. The following Industry Update provides insight about their thinking on this new initiative. Background: After a trial period in March 2014 and a round
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