We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
Service Highlight: US and Serbia!
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 with 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.
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
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 final order on EPPG and PSA devices
18 April 2016
The US Food and Drug Administration (FDA) has issued a 'final order'in the Federal Register to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls), and will in future be subject to clearance under the premarket notification (510(k)) program.
This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.
Following the effective date of this final order, 18 April 2016, firms marketing an EPPG or PSA device must comply with the applicable mitigation measures identified in the special controls. Manufacturers of EPPG or PSA devices that have not been legally marketed prior to the effective date, or models (if any) that have been marketed but are required to submit a new 510(k) because the device is about to be significantly changed or modified, must obtain 510(k) clearance and demonstrate compliance with the special controls included in this final order, before marketing the new or changed device.
FDA publishes quality system inspection data for 2015
12 April 2016
The US Food and Drug Administration (FDA) has issued its report on the quality system inspections carried out by its investigators during 2015. A press release from RAPS summarising the report can be accessed here, and a presentation of the major findings can be found here.
The headline from the report is that non-US inspections continue to rise in both number and as a percentage of the total number of inspections carried out: 620 non-US inspections in 2015 (increased from 594 in 2014) represented 29.5% of all inspections, as shown in the following chart:
In 2015, FDA says it issued 924 Form 483s after medical device inspections, which accounted for more than 3,500 individual observations. Of the inspections, 11% resulted in 483s citing significant objections, with 43% citing minor objections. Foreign manufacturers were more likely to be cited for serious observations than domestic manufacturers. Only 10% of domestic inspections resulted in citations for serious observations, whereas 15% of foreign inspections did.
Observations for corrective and preventative action (CAPA) and production and process controls issues each accounted for nearly one third of all observations, which is consistent with previous years. Though the number of 483s decreased in 2015, the number of warning letters issued remained the same as the previous year at 121, with nearly half (59) going to foreign firms.