GMP News - Medical Devices

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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09.04.13

FDA publishes Draft on Medical Devices Recalls Guideline

The FDA has published an independent industry guideline on product recalls, biological and medical devices. The guideline describes deficiencies which refer to regulations like for example the GMPs. Sometimes, recalls are made to serve product enhancement. In order to clearly distinguish product recalls from product enhancements, the FDA published at the end of February a draft guideline. Read more here.

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09.04.13

GMP for Medical Devices - ANVISA's Inspection Guide

The Brazilian monitoring authority ANVISA has integrated an inspection check list to the GMP guideline for medical devices. As these GMP requirements are very similar to the US American ones (21 CFR 820, Quality System Regulations, QSR), this inspection check list may also be useful for companies who want to export in the USA. Read more here.

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09.04.13

FDA's Strategies on the Regulation of Medical Products: How do they look like?

FDA's Center for Devices and Radiological Health (CDRH) published its strategic objectives regarding medical devices for 2013 in a document entitled "2013 Strategic Priorities". The document is composed of 12 pages which ... read more.

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09.04.13

How are FDA GMP Guidelines on the Regulation of Medical Devices made?

Have you also always wondered how the FDA gets its guidelines? As concerns GMP documents on the regulation of medical devices the "Device Good Manufacturing Practice Advisory Committee" (DGMPAC) plays an important role. It is the ... read more.

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14.02.13

FDA publishes List of planned Guidances for Medical Devices

At the end of 2012 the Center for Devices and Radiological Health (CDRH) published a list with the Guidances planned for the fiscal year 2013 (1 October 2012 to 30 September 2013). Read more here.

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14.02.13

Regulatory Requirements concerning Quality Assurance of Medical Devices in Japan

Japan is an interesting market, also for medical devices. There exists a translation of the relevant Japanese regulation in the English language as concerns the regulatory requirements on the quality assurance of medical devices. The Japanese Ministry of Health, Labour and Welfare issued a Ministerial Ordinance under the number 136 in 2004 which also is available in English. Read more.

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