Your CRO partner for successful management of clinical studies in Europe, US and Canada for medical devices, IVDs and combination products.
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.
Juncker reverses decision on Commission home for devices, medicines and cosmetics
23 October 2014
According to the website of IVD Regulation Rapporteur Peter Liese, the President of the European Commission has reversed his decision to move responsibility for medical devices, medicines and cosmentics from Directorate Geneneral (DG) SANCO to DG ENTR, the industry directorate, following loud protests from may quarters, inclding Dr Liese and Glenis Willmott, the British MEP who will be Rapporteur for the remaning negotiations on the Medical Devices Regulation.
FDA issues guidance document for nucleic acid-based IVDs for detection of m. tuberculosis
22 October 2014
The US Food and Drug Administration (FDA) has published the document 'Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens: Guideline for Industry and Food and Drug Administration Staff'.
The agency explains that the guideline identifies measures that FDA believes will mitigate the risks to health associated with these types of device and provide a reasonable assurance of safety and effectiveness. It comments that companies submitting a 510(k) for a nucleic acid-based IVD for these intended uses will need either to
Comply with the particular mitigation measures set forth in the special controls guideline; or
Use alternative mitigation measures that demonstrate to the Agency's satisfaction that such alternative measures provide at least an equivalent assurance of safety and effectiveness.