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.
New VDI Guidelines for Barrier Systems, Medical Devices and HVAC systems
In August, the Association of German Engineers (VDI ="Verein Deutscher Ingenieure") released three interesting VDI guidelines. The topics addressed are tightness of containment systems, identification of critical impurities in the manufacturing process of medical devices as well as requirements on the planning and implementation of central HVAC systems. Find out more about the new VDI guidelines.
Data Integrity: Best Practices for using eHRs in Clinical Investigations
With the final guidance on the Use of Electronic Health Record Data in Clinical Investigations the US FDA intends to assist sponsors, clinical investigators, contract research organizations (CRO´s), institutional review boards (IRBs), and other interested parties in the use of eHR data in clinical investigations.
Notably low number of warning letters issued to device manufacturers in first half of fiscal year 2018
The evaluation of the FDA warning letters regarding medical devices of the first half of fiscal year 2017 yielded a remarkable low number of warning letters. Find out, what the evaluation of the medical devices warning letters in the first half of fiscal year 2018 showed.
What makes a medical device a medical device? New FDA guideline on product classification
On twelve pages, the new FDA guideline entitled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drug products, medical devices or others.
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".
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?
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.