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...
Medical Device Regulatory Intelligence Blog
Thomas Regulatory is assisting clients FDA Emergency Use Authorization Submissions due to COVID-19 Coronnavirus
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 Will Transition from 21 CFR 820 QSR to ISO 13485:2016 for Medical Device Quality Systems Audit Inspections in the Near Future
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In a draft Guidance Document issued in February 2019, FDA Clarifies the Safety and Performance Based Pathway for devices eligible for Abbreviated 510(k) .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.
ISO 14971 Standard for Risk Management for Medical Devices is currently being revised and updated with expected release in 2019.
FDA takes steps to improve communications with medical device companies concerning corrective actions in response to inspectional observations
The FDA recently issued a draft guidance titled Nonbinding Feedback After Certain FDA Inspections of Device Establishments, a requirement under the FDA Reauthorization Act of 2017 (FDARA). The draft guidance proposes a process by which companies can request from the FDA nonbinding feedback on certain kinds of documented inspectional observations...