Medical Device Regulatory Intelligence Blog
 

Based on the wide ranging variety of digital health apps and the changing landscape, it appears that at some point FDA may be required to have more regulatory oversight than currently is the case in this space. #FDA #510k #regulatoryaffairs #medicaldevice #meddevice #medtech #digitalhealth #healthtech #healthapps

The proposed rule change at HHS in January just prior to changing of presidential a administrativos did not make it through #FDA . It will therefore not be published in the federal register and will not come to pass. The class 2 devices proposed to become exempt from premarket notification will no longer have that option as it was proposed....

Interesting trends from this article and survey of medical device manufacturers on the #EUMDR 2017/745 and in some ways it shows there has been improvements in awareness and companies for the most part now realizing the cost and time and allocation of resources to obtain the #CEMark for #Medtech and #meddevice companies. Now less than 41 days on 26...

The FDA approved the first device of its kind that can possibly detect if a person has COVID-19 when they are asymptomatic. This device will help prevent possible exposures to the virus, as well as slow the spread of illness. This device is used after an abnormal temperature reading. It can be used on people ages 5 and up....

Today FDA highlights that there is no transmission of COVID-19 through Food or Food Packaging based on the research and that the SARS-COV-2 is not a Food Borne Virus, such as other known viruses. At least this is one less thing to worry about in the middle of the pandemic. Overall I am grateful to our public servants in public...

U.S. FDA recently issued an emergency use authorization (EUA) of the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19 which does not require a doctor's prescription and does not require a laboratory to provide results. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid...

In a sign that N95 Masks / Respirators are now being supplied in the US at a sufficient quantity to meet demand during the continued COVID-19 Pandemic, the US FDA is currently no longer accepting new Emergency Use Authorization (EUA) submissions for Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China (i.e. KN95) due to the...

The EU Parliament has formally approved the extension of the date of application of the Medical Device Regulation 2017/745 until May 2021, adding an additional year for manufacturers to transition to EU MDR for their Technical Documentation and their Quality Management Systems. This will allow some manufacturers additional time to transition. While...

TRR is pleased to announce that due to the COVID-19 Pandemic due to Coronavirus, FDA has allowed for modified requirements for medical device manufacturers that wish to distribute their product during the public health emergency and pandemic. We are assisting manufacturers who can contribute to the supply of the much needed medical device products...

EU MDR 2017/745 impacting the medical device industry for CE Marking likely to be postponed due to COVID-19 Coronavirus. See link : https://audiovisual.ec.europa.eu/en/video/I-187348 #medtech #meddevice #medicaldevice