GMP News - Medical Devices

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.

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.

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.

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.

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.

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.

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.