A leading European CRO, Regulatory & Quality System consultancy for medical devices, IVDs and drug-device combination products operating in the EU and US.
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.
FDA announces large hike in device user fees for FY 2018
29 August 2017
Following President Trump's signing into law of the bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for drugs, biosimilars and medical devices through 2022, the agency has now published the fees for device-related interactions with FDA. The new fees, which become effective from 1 October 2017, reverse the trend from the previous few years, which saw a small reduction in fees, with 510(k) fees doubling, and a new high fee being introduced for de novo 510(k) applications. Significant discounts apply for small businesses (turnover less than $100M), however.
The new fees (as corrected by FDA on 29 August 2017) are:
‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Copies of the 'FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments', can be obtained from here.
19 cities vie for EMA after Brexit
4 August 2017
The European Commission has received 19 offers from European cities to host the European Medicines Agency's (EMA) headquarters as it moves from London's Canary Wharf following Britain's decision to leave the EU. A final decision on the new location will be taken at the General Affairs Council and announced on 20 November 2017. The cities that have applied to host the EMA as of 1 August 2017 are:
The Commission's assessment will be based on six criteria agreed to by the 27 member states, including operationality guarantees (the availability of appropriate offices), location accessibility (which includes the frequency and duration of flight connections), schools for EMA staffers' children (including the availability of multi-lingual schools), access to the labour market and health care for staffers' families, business continuity (to maintain and attract highly qualified staff) and geographical spread.