GMP News - Medical Devices

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.

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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.

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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)".

 

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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.

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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.

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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.

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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.

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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.

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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.

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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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29.08.13

New FDA Guidelines for Medical Devices

Because of the number and complexity of medical devices, FDA's Center for Devices and Radiological Health (CDRH) has published many new guidelines. This makes it difficult to keep track of the current situation. In the following, we have compiled a selection of new FDA documents with regard to aspects of quality assurance and marketing authorisation ... Read more here.

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29.08.13

What about the Successor Organisation (IMDRF) of the GHTF?

In one of our News we reported about the end of the Global Harmonisation Task Force (GHTF) and presented the International Medical Device Regulators Forum (IMDRF) as successor organisation. For a start, the IMDRF has taken over the "old" GHTF guidelines and plans to develop them further successively where necessary. First efforts have now been made. Read more here ...

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29.08.13

FDA Publishes Guidance on Clinical Trials

At the beginning of August, the FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011 in which a few comments … read more here.

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13.08.13

European Commission publishes Recommendations for the Labelling of Medical Devices

There are no specific provisions regarding the traceability of medical devices in the European regulatory framework for medical devices. That’s why the EU Commission has now published "Recommendations on a common framework for a system of unique product marking for medical devices". Read more.

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13.08.13

What's new from the FDA regarding Medical Devices?

In hardly any other area the FDA ‘s Center for devices and radiological health publishes so many guidelines as in the area of medical devices. Find out what has been achieved in the last few months.

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