There are important differences in the FDA approach of regulating in vitro diagnostic devices (IVDs) compared to other types of medical devices. This also applies to clinical data requirements. This training course will cover IVD-specific regulations, standards, and testing requirements, as well as, differences between US and European requirements.
US regulatory framework for IVDs
Regulatory pathways to FDA clearance
US guidances & CLSI standards
Quality system requirements
Code of Federal Regulations: applicable parts (50, 54, 56, 812 …)
US versus European requirements
IVD clinical studies: from design to successful FDA clearance
Planning a performance evaluation study
Practical aspects of Good Clinical Practices (GCPs)
Key aspects of study protocol
Site selection and use of non US data
Ethical aspects and the informed consent process
Data collection and statistics
Final study report
Carlo d’Alessandro, Director, IVD Quality and Regulatory Daniela Karrer, Director Clinical Affairs Matteo Mosso, Clinical Project Manager
FDA publishes final complete guidance on UDI database
29 June 2014
The US Food and Drug Administration (FDA) has issued final guidance for developers of mobile medical applications ('apps'), which run on smart phones and tablets. The guidance outlines the Agency's 'tailored approach' to mobile apps, explaining that it will "exercise enforcement discretion" for the majority of apps, as they pose "minimal risk to consumers". FDA will focus its regulatory oversight on a subset of apps that present a greater risk to patients if they do not work as intended.
"Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly. The FDA's tailored policy protects patients while encouraging innovation", said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH).
The guidance identifies mobile medical apps for closer attention from the agency that:
Are intended to be used as an accessory to a regulated medical device - for example, applications that allow a specific diagnosis by viewing a medical image; or
Transform a mobile platform into a regulated medical device - for example, an application that turns a smartphone into an electrocardiography (ECG) machine.
Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices. FDA has cleared around 100 mobile medical apps over the past decade.
Shuren added: "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products".
The FDA publication follows quickly after the Australian Therapeutic Goods Administration (TGA) published its own guidance on the subject.