Medical Device Regulatory Intelligence Blog
 

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

US FDA has published over 95 new guidance documents in 2019 alone. See the list here: https://www.fda.gov/drugs/guidance-compliance-regulatory-information and count on Thomas Regulatory Resolutions for your medical device #consulting needs in #regulatory #qms #meddevice #medicaldevice #fda #ISO13485 #510k #medtech #usagent

FDA has formally announced its intention to transition away from the Quality Systems Regulation (QSR) per 21 CFR 820 and transition to the ISO 13485:2016 for its audit inspections of medical device manufacturers. The new rule could be released as soon as mid 2019 and will roll out over the next few years. Industry should begin to perform any...

Manufacturers may not always take a Total Product Life Cycle (TPLC) approach when preparing their medical device 510(k) Submissions to FDA. This could lead to disconnects down the road if the pre-market, post-market, and quality management systems are not integrated from the get go.

In a draft Guidance Document issued in February 2019, FDA Clarifies the Safety and Performance Based Pathway for devices eligible for Abbreviated 510(k) . The updated guidance is found here: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM604195.pdf

The FDA recently released a guidance document to standardize the way that FDA conducts medical device establishment registrations.