GMP News - 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".

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).

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.

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.

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.

Some time ago, we referred to FDA's participation in the Medical Device Single Audit Program (MDSAP) Pilot. Now, further details on this program are available for manufacturers of medical devices.

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.