With the new EU MDR, companies must comply with several new requirements. Our previous blogs gave a snapshot of what has changed in the new EU MDR and how as a Medical Device manufacturer you can best deal with these changes. You can read some...
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for developers of genetic tests. Upon completion...
The three-year transition period to the EU MDR does not only engage the Regulatory Affairs personnel in Medical Device companies but also the entire business leadership as well. Companies are still in the three-year transition period to comply with the EU MDR. This transition does not...
The government has temporarily “re-opened” until Feb 15th after the longest government shutdown in US history that lasted for 35 days. Here’s what’s going to happen: Some FDA officials carried out inspections and other critical activities without being paid to continue to respond to threats to public...
The field of mobile medical applications (apps), software that run on smartphones or other mobile communication devices, has grown incredibly in both the number of applications available and the nature of the medical application. In this article, we review types of mobile apps and the...
In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify devices through distribution and use. At this time, requirements have already been phased in for Class II and Class III devices. Manufacturers for Class I/unclassified devices still have...
On January 7th, FDA released a working model for the software pre-certification pilot program version 1.0. The working model is open for public comments on the docket until March 8th, 2019. In our blog FDA’S DIGITAL SOFTWARE PRE-CERTIFICATION PROGRAM, we discussed how the program will...
In contrast to 2014, news on the Ebola virus today is relatively minimal. However, Ebola outbreaks are still occurring, most recently in the Democratic Republic of Congo. This article reviews the response of the U.S. FDA to the Ebola virus and programs that have encouraged...
On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one percent of the FDA staff has been furloughed, which means that out of 17,397 FDA staff members, only 10,344 members have been retained for work.1 The number of furloughed employees may...
FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, 510(k) submitters can voluntarily send their 510(k) to recognized organizations (“3PROs”) for review. This article provides an overview of the 3P program and recent updates that affect...