GMP News - Medical Devices

18.02.20

How to authorize a Combination Product in the USA?

In the USA, combination products are regulated independantly.  A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.

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18.02.20

When does the FDA announce the Inspection of a Medical Device Manufacturer?

With the entry into force of the FDA Reauthorization Act (FDARA) in August 2017, sections on the inspection of medical device manufacturers in the USA and abroad also became effective. A draft document from the FDA on inspections of medical device manufacturers has been issued for some time now to further harmonize and interpret the changes.

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18.02.20

Guide on the Use of Type V Drug Master Files for Combination Products

In October 2019, the FDA issued guidelines in a draft document regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.

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08.01.20

Risk Management Standard for Medical Devices ISO 14971:2007 revised

The currently valid ISO 14971 of 2007 will now be replaced by the version from 2019 (revision 3). The standard is applicable to all phases of a medical device´s life cycle. What is new?

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28.08.19

Medical Devices Warning Letters Statistics for the first half of Fiscal Year 2019

In both years 2017 and 2018 (period from October 1 to September 30), we reported a noticeably low number of Warning Letters. This seems to go on in 2019.

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21.08.19

What is a Combination Product?

The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).

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19.08.19

How to quickly find out about FDA requirements for Medical Devices?

In the USA, medical devices are regulated within the FDA by the Center for Devices and Radiological Health (CDRH). How can one quickly familiarize oneself with the topic of "medical devices" or stay up to date? For this purpose, the FDA offers an own website: CDRH Learn.

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19.08.19

Experiential Learning Program of the CDRH

Under the heading "CDRH's Experiential Learning Program", the FDA offers an interesting advanced training program. It is aimed at FDA employees who are "reviewers", i.e. who evaluate medical devices as part of the "approval procedure". The idea behind the program is...

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19.08.19

FDA Feedback after an Inspection at a Medical Device Manufacturer

In a draft guideline, the FDA informs that in future they will offer (nonbinding) feedback following an FDA inspection at a medical device manufacturer. What does this mean?

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31.07.19

EMA publishes Draft on Quality Requirements for Combination Products

The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?

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18.07.19

Qualification of Development Tools for Medical Devices - FDA Website

In our News dated 25 September 2017, we announced the finalisation of an FDA guideline for the qualification of development tools for medical devices. Since this topic is very important for the FDA, a website has been dedicated to it. It is available on the Internet.

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18.07.19

Update of the borderline guideline on medical devices

At what point is a medical device to be considered a medical device in Europe? The classification of so-called borderline products is sometimes difficult. An updated EU guideline may be able to help.

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09.07.19

ATMPs in combination with a medical device - QP task on release

With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.

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10.01.19

Cleaning Validation of Medical Devices: What should it look like? An ASTM Guide provides Answers

There are regulations for cleaning validation in the pharmaceutical sector and in the manufacture of active ingredients. But what about the cleaning validation of medical devices?

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10.01.19

Things to Consider for Medical Device Manufacturers when Relocating

In December 2018, the FDA  published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?

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