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).
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.
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...
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?
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.
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.
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?
New Ph. Eur. Structure of Chapter 3 on Materials and Containers
The Ph. Eur. Commission decided to restructure Ph. Eur. Section 3 on materials and containers. A new Subsection 3.3. has been added to cover items that are classified as medical devices according to EU legislation. Read more about 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place
You can regularly read about an evaluation of the deficiencies in FDA warning letters concerning medical devices. Find out what the past fiscal year looked like in terms of FDA Warning Letters regarding medical devices and what changed compared to fiscal year 2017.
EU guidance for new Medical Device Regulation (MDR)
With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.
At what point is a medical device considered a medical device in Europe? So-called borderline products sometimes cause problems regarding classification; a guideline on Borderline products by the European Union may be of help.