It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in compliance with the Food, Drug, and Cosmetic (FD&C) Act? A hearing was held on May 31 to discuss just that. Many...
With the continued advances of Artificial Intelligence and Machine Learning (AI/ML), we are at the forefront of a new medical device era. In our previous blogs AN UPDATE ON FDA’S DIGITAL SOFTWARE PRE-CERTIFICATION PROGRAM and MODIFICATION AFTER INITIAL REVIEW AND...
With less than a year until the end of the EU MDR transition period, it is pertinent to ensure that all devices to be sold in Europe comply. We’ve been highlighting many of the new requirements in our blogs, including: INTRODUCTION...
Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance – reactive and proactive. Reactive is the most common approach used when setting up a PMS system, but that doesn’t mean a proactive approach isn’t...
A root cause is a factor which caused a nonconformance and should be permanently eliminated through process improvement. Finding the root cause is done through root cause analysis which is a term describing a collective of approaches, tools, and techniques...
On May 8, 2019, FDA released draft guidance, Clinical Lactation Studies: Considerations for Study Design, building upon the previous guidance, Clinical Lactation Studies – Study Design, Data Analysis, and Recommendations for Labeling, released in 2005. The draft guidance is expected...
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and...
On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / Machine Learning (AI / ML) based Software as a Medical Device (SaMD) and is taking public comments on the proposal until June 3, 20191....