We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effecti vely.
DLC will take part in the exhibition that forms part of the ICI 2016 Innovations in Cardiovascular Interventions Meeting, 4-6 December 2016, Tel Aviv, Israel. Representing DLC will be Daniela Karrer, Director, Clinical Affairs, and Matteo Mosso, Clinical Project Manager, who look forward to meeting both existing and new clients at Booth 37.
We are happy to announce the appointment of Ana-Maria Panaitoiu, M.D. as US Clinical Services Coordinator and Predrag Vasiljević, M.D, as Senior CRA for Serbia.
Ana-Maria brings to the DLC team extensive experience in the management and monitoring of US and Canadian clinical studies for medical devices and IVDs, together wit h her expertise in several therapeutic areas.
Predrag will allow DLC clients to benefit from qualified monitoring and site selection services in Serbia as well as in other Eastern Europe countries.
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 plans to make certain home-use device labeling available to public
16 October 2016
The US Food and Drug Administration (FDA) has published a proposed rule that would require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA, which would then be made available to the public through the internet. The agency would also provide search tools to facilitate locating information concerning a particular home-use device or a particular type of home-use device.
Details of the proposed rule are available from here, in which is is explained that the electronic submission requirements of the rule would be limited to only devices labeled for home use that are regulated by the Center for Devices and Radiological Health (CDRH) as Class II and Class III devices. For purposes of the proposed rule, a “home-use device” is any medical device that is labeled for use outside a professional health care facility. FDA comments that sampling information indicates that this device group has a higher risk of misuse due to lost or misplaced labeling and operating instructions. In addition, the proposed rule would allow the voluntary electronic submission of device labels and package inserts for any Class I home-use device or other home-use device not subject to the electronic submission requirements of the rule.
FDA will use the existing FDA's Unified Registration and Listing System (FURLS) database and software systems to receive the submitted electronic labeling information and will bear the incremental cost of launching and maintaining the FDA-managed or partner Web site to display and make the submitted information available for the public to search and retrieve. The benefits of the proposed rule would stem from a reduced incidence of adverse events due to the increased availability of medical device labeling, according to FDA.
New guidance documents from FDA
12 October 2016
Over the last few weeks, the US Food and Drug Administration has published a number of new draft and final guidance documents, including:
We very much appreciate the kind comments that we have received from our clients. Here are just a few of them.
I can share [with] you that working with Mrs. Karrer and her colleagues is a real pleasure, given their professionalism, knowledge and experience in the field of clinical regulation and research. I am sure you will enjoy their assistance through long term of clinical cooperation between your hospital and [our company].
Israeli medical device company writing about Daniela Karrer, Director, Clinical Affairs and our clinical department