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.
Risk Management SOP Example for all Delegates of the ECA Course GMP for Medical Devices
All delegates of the ECA Course "GMP for Medical Devices" from 1-2 October 2014 in Heidelberg, Germany will receive a 17-page documentation with an FMEA SOP in English as well the associated FMEA form. Find out more about the free of charge add-ons.
The Center for Devices and Radiological Health (CDRH), responsible for medical devices at the FDA, publishes new guidelines and programmes on a regular basis. In this news you will find a short and selected overview of new, modified, or updated guidelines and programmes.
FDA plans Changes to the Classification of Medical Devices
At the end of March, the FDA announced in the Federal Register that changes to 21 CFR 860 (Medical Device Classification Procedures) were planned. The changes to 21 CFR 860 are required to fulfil the necessary provisions from the "Food and Drug Administration Safety and Innovation Act (FDASIA)".
FDA publishes Guidance for Industry on "Investigation Device Exemptions (IDE)"
At the end of 2013, the FDA released the final version of the Guidance for Industry and FDA-Staff on "Investigation Device Exemptions (IDEs) for Early Feasibility Medical Devices Clinical Studies Including Certain First in Human (FIH) Studies". The document is composed of 40 pages, which ... Read more here.