GMP News - Medical Devices

26.02.15

FDA releases Details on Medical Device Single Audit Programm Pilot

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.

26.02.15

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.

26.02.15

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.

04.09.14

What's new from the FDA regarding Medical Devices?

What is new in terms of FDA Guidelines or Draft Guidelines regarding medical devices? To find a selection from the last 6 months please read on.

04.09.14

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.

04.09.14

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.

10.04.14

Overview of new CDRH Guidelines

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.

10.04.14

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)".

10.04.14

FDA publishes Medical Device Recall Report

The FDA has published an overview over the evolution of medical device recalls between the fiscal years 2003 and 2012. Read more here.

10.04.14

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.

18.12.13

New Developments in the EU with regard to Medical Devices

After the "PIP scandal", the EU had announced a reform of the medical device regulation. Proposals were published in October 2012. Now, there are further developments. Read more here.

19.11.13

FDA publishes Guidance for Industry on "Investigation Device Exemptions (IDE)"

On 1st October 2013, the FDA published 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.

19.11.13

FDA will participate in a Medical Devices Single Audit Pilot Programme in 2014

At the beginning of 2014, the FDA will participate in a pilot programme on MDSAP together with the respective monitoring authorities in Australia, Brasilia and Canada. Read more here.

19.11.13

What's the News from the FDA regarding Medical Devices?

In irregular intervals, the team of CONCEPT HEIDELBERG publishes overviews over new FDA's Guidelines or Draft Guidelines regarding medical devices. In the following, you will find a selection from August/ September/ October. A new ... Read more here.

12.11.13

Medical Devices Warning Letter Statistics 2013 - Rank 1 for CAPA Deficiencies once more

On behalf of the European Compliance Academy, the team of Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for fiscal year 2013 (from 1st October 2012 to 31 September 2013). Read more here.

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GMP News - Medical Devices

FDA releases Details on Medical Device Single Audit Programm Pilot

CAPA - What does the FDA expect from Medical Devices Manufacturers?

FDA Statistics with regard to 483 Inspectional Reports at Medicinal Products Manufacturers

What's new from the FDA regarding Medical Devices?

What's new from the IMDRF (the successor organisation of the GHTF)?

Risk Management SOP Example for all Delegates of the ECA Course GMP for Medical Devices

Overview of new CDRH Guidelines

FDA plans Changes to the Classification of Medical Devices

FDA publishes Medical Device Recall Report

FDA publishes Guidance for Industry on "Investigation Device Exemptions (IDE)"

New Developments in the EU with regard to Medical Devices

FDA publishes Guidance for Industry on "Investigation Device Exemptions (IDE)"

FDA will participate in a Medical Devices Single Audit Pilot Programme in 2014

What's the News from the FDA regarding Medical Devices?

Medical Devices Warning Letter Statistics 2013 - Rank 1 for CAPA Deficiencies once more

Recommended Event

Modern Microbiology Laboratory Mastering the challenges of classic and modern microbiological methods

GMP News - Medical Devices

FDA releases Details on Medical Device Single Audit Programm Pilot

CAPA - What does the FDA expect from Medical Devices Manufacturers?

FDA Statistics with regard to 483 Inspectional Reports at Medicinal Products Manufacturers

What's new from the FDA regarding Medical Devices?

What's new from the IMDRF (the successor organisation of the GHTF)?

Risk Management SOP Example for all Delegates of the ECA Course GMP for Medical Devices

Overview of new CDRH Guidelines

FDA plans Changes to the Classification of Medical Devices

FDA publishes Medical Device Recall Report

FDA publishes Guidance for Industry on "Investigation Device Exemptions (IDE)"

New Developments in the EU with regard to Medical Devices

FDA publishes Guidance for Industry on "Investigation Device Exemptions (IDE)"

FDA will participate in a Medical Devices Single Audit Pilot Programme in 2014

What's the News from the FDA regarding Medical Devices?

Medical Devices Warning Letter Statistics 2013 - Rank 1 for CAPA Deficiencies once more

Recommended Event

Modern Microbiology Laboratory Mastering the challenges of classic and modern microbiological methods

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