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...
We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was hard-hitting while some were received with a warm welcome by industry professionals. It sure is a difficult and confusing time for the medical device industry to...
Medical Device manufacturers selling their devices in the European Union are currently in a three-year transition period to comply with the new EU MDR 2017/745. There are quite a few changes proposed in the new regulation that medical device companies need to establish compliance with;...
We all know how being MDSAP certified opens doors to market a device in the USA, Canada, Japan, Brazil, and Australia. Health Canada now requires medical device manufacturers to be MDSAP certified prior to January 1st ,2019 to be able to legally market medical devices...
Direct-to-consumer (DTC) tests, such as those marketed by 23andMe, are changing the classic paradigm of health professionals ordering and interpreting genetic testing for a patient. In this article, we provide an overview of the DTC landscape and the regulatory pathways. Not all direct-to-consumer (DTC) genetic tests...