MHRA publishes Guideline on Borderlines with Medical Devices
When is a medical device considered a medical device and when isn't it? The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) tries to answer this question in a 12-page guideline. Here you can find a summary of the MHRA guideline "Borderlines with medical devices".
FDA Status Report Medical Devices Single Audit Programme
A programme led by the FDA is currently running in the area of medical devices: the Medical Devices Single Audit Programme (MDSAP). Read more about an interim report of the FDA presenting the current status and the further steps.
Medical Devices Warning Letter Statistics 2015 - Process Validation again in the Top 5
In a recent news we reported about statistics of the FDA from the first half year 2015 with regard to Warning Letters addressed to medical devices manufacturers. Please read more about the current evolution of the top 5 list regarding medical devices for the complete fiscal year 2015 (1 October 2014 to 30 September 2015, as of 10 October 2015).
FDA publishes List of Planned Guidances on Medical Devices for 2016
At the end of 2015, the Center for Devices and Radiological Health (CDRH) published a list containing the guidelines planned for fiscal year 2016 (1st October 2015 - 30 September 2016) as well as older guidelines which might be updated. Learn more about the planned FDA Guidances.
FDA's Current Publications for Manufacturers of Medical Devices
In irregular intervals, the ECA publishes overviews of new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more about the current publications of the FDA.
Quality Metrics - Required for Medical Devices too?
Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, the FDA is now pursuing a similar path. Under the heading "Case for Quality" (CfQ), the FDA would like to improve the quality of medical devices.
Current FDA Publications for Medical Device Manufacturers
In irregular intervals, the ECA publishes overviews of the FDA's new guidances or draft guidances, webinars, general strategy papers and inspection results concerning medical devices. The following is a selection of medical device related publications of the past six months.
Update on FDA Strategies regarding Medical Devices
The FDA Center for Devices and Radiological Health (CDRH) has published its strategic goals on medical devices for 2013 in a document entitled "2013 Strategic Priorities." Read more about the recent FDA release of a location determination and further development of these strategies.
FDA's Recent Publications for Manufacturers of Medical Devices
In irregular intervals, the team of CONCEPT HEIDELBERG publishes overviews over new guidelines or draft guidelines, webinars and general strategy papers, and inspection outcomes of the FDA with regard to medical devices. Find out more about the FDA's most recent publications.
UDI and GUDID: FDA's Presentation Slides Available
In the past, the ECA has often reported about the Unique Device Identifier topic. In the meantime the Unique Device Identifier (UDI) and Global Unique Device Identification Database (GUDID) topics have taken on great importance at the FDA. Read more about the FDA presentation slides on UDI and GUDID available on the FDA website.
CAPA - What does the FDA expect from Medical Devices Manufacturers?
Deficiencies with regard to CAPA (Corrective and Preventive Action) are regularly Top 1 in FDA's Warning Letter statistics. The FDA has just recently published presentations in form of webinars. One of them addressed the topic of CAPA.
FDA Statistics with regard to 483 Inspectional Reports at Medicinal Products Manufacturers
The Warning Letter statistics for fiscal year 2013 with regard to manufacturers of medical device have been taken as a comparison by the FDA to comment on the current ranking of the 483 Forms issued. Read more here.
What's new from the IMDRF (the successor organisation of the GHTF)?
At the end of 2012, the International Medical Devices Regulator Forum (IMDRF) replaced the Global Harmonisation Task Force which had been in charge until then of the worldwide harmonisation of requirements for medical devices. Read more about the current stand of IMDRF's publications.