GMP News - Medical Devices

07.09.23

Tips for commenting on FDA Guidance Documents

The FDA Center for Devices and Radiological Health (CDRH), which is also responsible for medical devices, has published tips on how to comment on guidance documents issued by the CDRH. What does it say?

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07.09.23

Changes in the Notified Body Postion Paper on Hybrid Audits

End of January 2023 you could already read about a 3.5 page position paper from Notified Bodies regarding their perspective on hybrid audits of medical device and IVD manufacturers. The position paper has now been updated.

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05.09.23

How to create a Notified-Body-compliant Technical Documentation

One of the most important documents in the context of medical device regulation is the technical documentation. Recently updated to version 2, a helpful position paper from Team Notified Body serves as a best practice guide on this topic. Read more here.

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29.06.23

How to create a Notified Body compliant Technical Documentation?

One of the most important documents in the context of medical device regulation is the technical documentation. Updated as version 2, a helpful position paper from the Team Notified Body provides assistance in this regard as a best practice guide.

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29.06.23

Dealing with Artificial Intelligence in the Context of the further Development of Software in Medical Devices

The topic of artificial intelligence/machine learning (AI/ML) is currently all around. The FDA has also taken up AI/ML and published various draft guidance documents. A current draft is aimed at manufacturers of medical devices that contain software.

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26.01.23

Recommendations of Notified Bodies on Hybrid Audits in the Medical Device Sector

In a 3.5 pages position paper, Notified Bodies have presented their views on hybrid audits of medical device and IVD manufacturers. What does it say?

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26.01.23

FDA Inspection delayed, denied or restricted for the Inspector - what happens?

What happens if an FDA inspection is delayed, refused or restricted for the inspector?

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26.01.23

FDA publishes Lists of planned Medical Device Guidances 2023

In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?

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08.11.22

Final FDA Guidance on Comparability Protocols

The FDA released the final guidance on Comparability Protocols for postapproval CMC changes. The revised guidance follows the draft version issued in April 2016.

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19.10.22

Medical Device Warning Letter Statistics for Fiscal Year 2022

The ECA regularly analyses the deficiencies identified in FDA Warning Letters relating to medical devices. Since medical devices can also be part of a combination product of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What do the medical device Warning Letter statistics show for the 2022 fiscal year?

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04.10.22

Breakthrough Device Programme of the FDA

The FDA presents its "Breakthrough Device Programme" on their website. What does it say?

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04.10.22

New Article on CDRH Learn

You could already read in the past about the FDA CDRH's website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date. What is new?

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04.10.22

Risk Management Plans to Mitigate Drug Shortages also affect Medical Devices

In a draft document, the FDA has presented risk management plans to mitigate drug shortages. What are those plans?

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13.09.22

FDA's recommended Font and Font Size for Instructions for Use Labeling

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?

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30.08.22

Medical Device Information available on EMA's Website

We have already reported about information regarding medical devices available on the EU Commission's website. Recently, a chapter on in vitro diagnostics (IVDs) was added. Also, the EMA website has a dedicated page for medical devices. What can be found there?

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