GMP News - Medical Devices

16.08.18

New WHO guideline on medical devices and IVDs

On 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".

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13.06.18

FDA opens Docket on Software Products

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

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19.12.17

Warning Letter on Combination Products 21 CFR 4

For several years, combination products have been regulated by 21 CFR 4 in the USA. In September 2017, the FDA issued a Warning Letter to a manufacturer of combination products. What did the FDA criticise?

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19.12.17

2017 Medical Devices Warning Letters Statistics

In the first half of Fiscal Year 2017 review you could read about the Warning Letters issued to manufacturers of medical devices during 1 October 2016 through 31 March, 2017. Now, the numbers of Medical Device Warning Letters for the entire fiscal year 2017 (1 October 2016 - 30 September 2017) are available.

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19.12.17

New WHO Guideline for Medical Devices and IVDs

The WHO has published a finalised 76-page regulatory framework for medical devices including in vitro diagnostic medical devices (IVDs) divided into 5 chapters. What is the purpose of the document entitled "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices"? 

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19.12.17

New FDA Guideline on Product Classification - what is a Drug, what isn't?

The new FDA guideline titled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drugs, medical devices or other.

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10.10.17

MHRA elaborates on new EU regulations for medical devices and IVDRs

Despite Brexit, the British "Medicines and Healthcare products Regulatory Agency" (MHRA) informs about new EU regulations for medical devices.

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10.10.17

Handling of Changes to Medical Device Products for approved Combination Products

In a recent news you could read about a question-and-answer document from the EMA, describing certain issues concerning the handling of changes after approval ("variations"). This document has been updated again. The topic of changes to medical devices after the approval of "combination products" has now been added.

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25.09.17

Qualification of Development Tools for Medical Devices - Guidance for Industry

The topic of development has been playing an important role for the FDA, not only in the pharmaceutical sector, but also with regard to medical devices for quite some time. An FDA draft guidance document on the qualification of development tools from 2013 has now been finalized. 

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25.09.17

Remarkably few Warning Letters to Medical Device Manufacturers in the first Half of Fiscal Year 2017

The ECA evaluates deficiencies regarding medical devices in FDA Warning Letters on a regular basis. Remarkable is the low number of Warning Letters to medical devices manufacturers in the first half of fiscal year 2017.

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25.09.17

Current FDA Publications regarding Medical Devices

In irregular intervals, the ECA publishes overviews about new guidelines or guideline drafts, webinars, general strategy papers and about FDA inspection results regarding medical devices. Find out what the FDA issued recently with regard to medical devices.

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28.03.17

Validation vs. Verification of Medical Devices - An Interesting FDA Warning Letter

It its cGMP regulations for medical devices (21 CFR 820 (Quality System Regulations), the FDA also addresses the topic of validation (21 CFR 820.75). In the course of its inspections, the authority reviews the validation of the manufacturing processes. The FDA criticised according deficiencies at a Taiwanese medical devices manufacturer with a Warning Letter.

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28.03.17

MHRA Guideline on Re-Manufacturing of Single-Use Medical Devices

Last year the MHRA published a 11-page guidance about the re-manufacturing of single-use medical devices (SUDs). Alhough only valid for the UK the content of the MHRA Guidance on Single-Use Medical Devices is interesting.

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28.03.17

EMA Concept Paper on Combination Products

Since February, 16th 2017 you can comment on a concept paper of the EMA on the development of a guideline with regard to the quality requirements of "combination products" - called "Drug-Device-Combination" (DCC) in the document.

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12.01.17

FDA publishes Final Guideline on GMP for Combination Products

In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and the final version of the FDA Guideline for Combination Products?

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