We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
GAP ANALYSIS FOR CLINICAL STUDIES
Is your company experiencing problems with your clinical study, such as enrolment issues or significant delays in study start? Our clinical gap analysis will help you understand the problems and implement solutions. Learn more.
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 publishes User Fees for Fiscal 2016
4 August 2015
The US Food and Drug Administration has published its user fees for fiscal year 2016 together with revised guidance on 'FY 2016 Medical Device User Fee Small Business Qualification and Certification', available from here.
The fees for 2016 are as follows:
FDA updates 'Refuse to Accept' (RTA) guidance and checklists
4 August 2015
The US Food and Drug Administration (FDA) has published an update to its guidance document explaining the agency's 'Refuse to Accept' policy, introduced at the end of 2012, with the aim of saving agency time reviewing incomplete 510(k) submissions.
The new guidance, published on 4 August but not taking effect until 1 October 2015, according to FDA, "does not represent a significant change to the prior version of the guidance, but rather is targeted to assist FDA review staff and industry by clarifying the types of information FDA believes are necessary to make a submission administratively complete".
The revised document also introduces changes to the checklists which FDA reviewers use to assess submission completeness. The guidance "encourages submitters to complete and submit acceptance checklists with their submissions that identify the location of supporting information for each RTA element".
FDA explains that the main chages to the guidance:
Clarify text to reflect checklist and RTA process modifications;
Remove language that had the potential to lead to substantive review [during the acceptance check];
Update references, guidance, and links within the document.
In addition, changes to the checklists include:
Removal of criteria non-critical to initiate review;
Addition of options to permit reviewer discretion to accept files lacking certain non-critical information;
Separation of elements better reviewed independently;
Modifications to reflect changes in review policy;
Clarification of text to improve understanding of information needed to address elements;
Clarification of text to remove language/elements that had the potential to lead to substantive review;
Combination of elements asking for similar information;
Clarification/update of elements per comments from FDA review staff and industry;
Update to references, guidance, and links;
Inclusion of a page number column to identify location of elements in submission.