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.
MHRA issues Safety Alert regarding delays in reacting to FSNs
29 September 2014
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a 'Medical Device Alert' to all hospital in the UK to advise that more attention should be paid to actions resulting from the issuance of Field Safety Notices (FSNs) by medical device manufacturers.
The Agency explains that an FSN is a communication sent by medical device manufacturers, or their representatives, in connection with a Field Safety Corrective Action (FSCA). FSNs outline actions to be taken by user organisations to reduce the risk of death or serious injury associated with the use of a medical device.
The Device Alert continues by stating: "It is very important that your organisation takes the actions detailed in the FSN and replies to the manufacturer, acknowledging receipt of the FSN. Your organisation's reply is the evidence that the manufacturer, and subsequently the MHRA, needs to monitor the progress of the FSCA. Without this reply the manufacturer cannot properly verify if the FSCA is complete and so the MHRA may need to issue advice. Your organisation could be liable if it does not act on safety information provided by the manufacturer and something goes wrong as a result."
A copy of the Device Alert can be accessed from here.
FDA issues draft guidance on abbreviated 510(k)s for EGR1 FISH devices
28 September 2014
A draft guidance titled 'Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices' has been published by the US Food and Drug Administration (FDA).
The Agency is issuing the draft guidance to provide industry and agency staff with recommendations for the suggested format and content of an Abbreviated 510(k) submission for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test systems for specimen characterization devices, together with recommendations for addressing certain labeling issues relevant to the review process specific to these devices. Comments are invited by 25 December 2014. To view the draft guidance, click here.