On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation, which sets out the FDA’s quality management system (QMS) requirements for medical devices. The amendments seek to align more closely with International Standard Organization (ISO) standard 13485:2016, Medical Devices —

On 22 February 2022, the U.S. Food and Drug Administration (FDA or the Agency) announced that it was issuing a proposed rule to align the Agency’s current Good Manufacturing Practice (GMP) requirements for medical devices, codified at 21 C.F.R. Part 820 and known as the Quality System Regulation, with the international consensus standard ISO 13485:2016 (the ISO). This reflects a years-long effort by the Agency to better harmonise the U.S. requirements with that of many foreign regulators. For example, in the European Union, the ISO is listed in the EU legislation, meaning that a medical device that conforms to this standard is presumed to be in conformity with the EU regulatory requirements on quality management systems for medical devices. This harmonisation should, therefore, provide some consistency between jurisdictions and enable companies to streamline their processes between countries.
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On 6 July 2017, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced a joint proposal to promote the use of innovative approaches to paediatric drug development. The proposal focuses on paediatric Gaucher disease, but the intention is for the principles underlying the so-called “strategic collaborative approach” to be extended to other areas of development for rare paediatric diseases.

The collaborative approach was considered necessary as, given the limited number of patients with Gaucher disease, identifying multiple candidate target products, and running multiple clinical trials, may actually hinder the development of an effective treatment.
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