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FDA Issues Draft Guidance on Combination Product Manufacturing
12 February 2015
Two years after issuing a final rule on current good manufacturing practice (cGMP) requirements for combination products, the US Food and Drug Administration (FDA) has announced the availability of draft guidance that explains the final rule and further clarifies how manufacturers should comply with cGMP requirements. Following publication of the final rule, there were requests for additional guidance on implementation, and FDA has reacted by issuing this draft.
The draft guidance reviews the definition of a combination product and reiterates that the final rule on cGMP requirements applies to all combination products. Accordingly, the final rule applies equally to:
A 'single entity' combination product, meaning a product comprised of two or more regulated components, that are physically, chemically, or otherwise combined or mixed and produced as a single entity (e.g., a prefilled syringe);
A 'co-packaged' combination product, meaning two or more separate products that are packaged together as a unit and comprise drug and device, device and biological, or biological and drug products (e.g., a surgical kit); and
A 'cross-labeled' combination product, meaning a drug, device, or biological product that is intended for use only with another separate drug, device, or biological product, where both are required to achieve the intended use, indication, or effect (e.g., a light-emitting device and a light-activated drug).
The draft guidance further clarifies the definitions of some of the key terms in the final rule, such as the distinction between drug containers and closures as compared to delivery devices, and usefully provides examples and hypothetical scenarios to further clarify how manufacturers can comply with the cGMP regulations in the final rule, addressing which cGMP responsibilities apply to specific manufacturers and illustrating steps sponsors can take to coordinate cGMP compliance across facilities.
Concurrent with the publication of this draft, FDA has withdrawn the September 2004 draft guidance entitled 'Current Good Manufacturing Practice for Combination Products'. Comments regarding the newly-issued draft guidance are due by 30 March 2015.
FDA releases final guidance on risks of misconnections in enteral systems
12 February 2015
The US Food and Drug Administration (FDA) has published the final version of the guidance document titled 'Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff', the draft of which was issued in July 2012.
FDA explains that the guidance "provides recommendations to manufacturers, FDA reviewers, and other entities involved in manufacturing devices that contain small-bore connectors designed for enteral feeding, as well as those submitting or reviewing premarket notification submissions [510(k)s] for these devices".
The guidance continues: "Small-bore connectors provide a mechanism for the connection between a variety of medical devices including those with enteral and non-enteral (e.g., intravenous) applications. The use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients."
The guidance recommends that manufacturers design and test enteral connectors based upon recognised standards, and if submitting a 510(k), proposes that a risk assessment should be undertaken to assess the risks of the proposed enteral connector misconnecting to non-enteral devices. Finally, the guidance states that color-coding, labeling, and tagging attached to a device, by themselves, are no longer sufficient to satisfy safety concerns regarding misconnection hazards.