We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
Your CRO partner for successful management of clinical studies in Europe, US, Canada and Israel 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.
FDA publishes final guidance on IDE process
19 August 2014
The US Food and Drug Administration (FDA) has issued a final guidance document titled 'FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff', commenting that the agency is "committed to improving US patient access to new devices by strengthening and streamlining the clinical trial enterprise so that clinical trials are conducted in the US in an efficient, cost-effective manner while maintaining appropriate patient protections".
The guidance describes the FDA’s decision-making and communications regarding applications from companies that want to conduct medical device clinical studies in the US. It also describes more flexible options for clinical study approvals that allow studies to begin sooner while ensuring patient protection.
The guidance outlines:
Processes to allow more efficient study enrollment;
Information regarding the FDA’s decision-making processes to improve predictability;
Communication routes intended to improve the transparency of FDA’s decision-making process.
FDA will hold a webinar on 4 September 2014 to explain the guidance and to provide a forum for asking questions.
New final documents available from IMDRF
18 August 2014
The International Medical Device Regulators Forum (IMDRF) has released two final documents, these being:
The documents provide "an internationally harmonized, modular, format for use when filing medical device submissions to regulatory authorities for market authorization". The documents are "comprehensive in scope in that they define the location of both common (IMDRF) and regional content for all submission types".
IMDRF further explains: "The ToC documents are intended to work together with a separate document created for each participating jurisdiction – a classification matrix. The classification matrix defines whether for the given submissions type a heading is required, not required, optional, conditionally required, etc. The classification matrices are the published under the authority of participating authorities and are not products of IMDRF, please consult regional regulator websites for further information".
The documents take forward the ideals of the now-defunct Global Harmonization Task Force (GHTF), established nearly 25 years ago to converge medical device regulatory approval systems from the major jurisdictions in the world.