We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
Your CRO for cost-effective medical device, in vitro diagnostic device, drug or combination product US and European clinical studies for worldwide acceptance.
A trusted resource for US and EU medical device regulatory and quality system requirements also providing EU Authorized Representative and US Agent services.
In Vitro Diagnostics
In Vitro Diagnostics
IVDs have distinct requirements in both the US and Europe. We have the IVD regulatory, quality system and clinical study expertise needed for US and European market entry.
Helping companies understand the important differences between US and European requirements for drug-device combination products and drug delivery devices.
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.
IMB issues Safety Notice on device intended use
27 June 2014
The Irish Medicines Board (IMB) has issued a Safety Notice titled “Intended Purpose of a Medical Device: Guidance for healthcare settings". The agency explains that: "Different products used in a healthcare setting may be similar based in appearance but may have a different intended purpose assigned to them by their manufacturer", and that "Products should only be used as specifically intended by the manufacturer of that product and not based on similarities with other products or medical devices".
The background to the Safety Notices is that: "It has come to the attention of the Irish Medicines Board (IMB) that products that do not meet the definition of a medical device are being used for a medical purpose based on their similarity in appearance to medical devices".
IMB is therefore recommending to healthcare facilities to:
(1) Ensure medical devices are used in accordance with the intended purpose specified by the manufacturer.
(2) Ensure that medical devices and other products are indicated for the particular purpose for which they are being used.
(3) Ensure that all medical devices purchased bear a CE mark* on the device, labelling or instructions for use.
Copies of the Safety Notice can be accessed from here.