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 issues draft on use of patient preference data in premarket submissions
15 May 2015
The US Food and Drug Administration (FDA) explains in a new draft guidance document, titled 'Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders' that it "values the experience and perspectives of patients with devices", understanding that patients and caregivers who utilize devices may have developed their own insights and perspectives on the benefits and risks of such devices that may be under PMA, HDE, or de novo 510(k) review.
The draft further explains that the Agency "believes that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices". For this reason, FDA’s guidance document 'Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications' explains that reviewers may consider certain data measuring patient perspectives during premarket review, when such information is available. The new draft takes the next step and provides guidance on patient preference information that may be used by FDA staff. The draft also proposes edits to the Benefit-Risk Guidance in an appendix.
Comments on the draft are requested by mid-August 2015, and copies can be downloaded from here.
FDA publishes draft guidance on use of adaptive design in clinical studies
15 May 2015
The US Food and Drug Administration (FDA) has posted a further draft guidance on its website, on the subject of 'Adaptive Design for Medical Device Clinical Studies'. When finalized, the Agency states that the guidance will provide clarity on the use of adaptive designs for clinical studies of medical devices.
The draft explains that "Adaptive design allows for planned modifications to a clinical study based on accumulating data, while maintaining the trial’s integrity and validity. When properly implemented, adaptive design can reduce resource requirements and/or increase the chance of study success." FDA comments that releasing the guidance will "further encourage companies to consider the use of adaptive design in their clinical trials".
The draft, available from here, has the full title 'Draft Guidance for Industry and Food and Drug Administration Staff: Adaptive Designs for Medical Device Clinical Studies', and comments are invited until 17 August 2015.