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.
Significant increase in FDA 510(k) fees likely from 2018
The fee for fiscal year 2017, which started on 1 October 2016, was reduced from the 2016 fee of $5,228 to $4,690, but the draft recommendations propose that the 510(k) fee should represent a higher proportion of the Pre-market Approval (PMA) submission fee than has previously been implemented, increasing it from 2% to 3.4% of the PMA fee. This would result in a 2018 fee of $9,996, increasing over the subsequent five years to $11,186, if the draft recommendations are approved.
In addition, a review fee for de novo 510(k) applications would be introduced. It is perhaps an anomoly that de novos do not currently involve payment of a fee, but the fee proposed for 2018 is 30% of the PMA fee, which is $88,200, rising to $98,700 for fiscal 2022.
Reduced fees for small businesses (revenues under $100M) will be retained, but with revised percentages of the standard fees. Thus, if registered as a small business with the agency, the 510(k) fee for fiscal 2018 will be 25% of the standard fee ($2,499) instead of 50%, thus roughly maintaining the current amount paid. For de novo submissions, the reduced fee will also be 25% of the standard fee ($24,675). While currently many 510(k) sponsors do not consider the time and resource to obtain small business status worthwhile, because of the relatively small savings to be gained, the new fee structure will make it much more worthwhile, especially for de novo applicants.
The base fee for a PMA application will rise to $294,000 in 2018, and the annual establishment registration fee will rise to $4,375.
It must be noted, however, that the figures for 2018 and beyond quoted above have all been established based on 2015 rates, and the new proposal includes a provision for FDA to increase the fees in line with inflation each year, so if the recommendations are approved, the actual fees for 2018 will rise further to reflect inflation during 2016 and 2017.
FDA has organised a public meeting on 2 November 2016, at its White Oak Campus, to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2018 through 2022, at which the public may present its views on the draft recommendations,following which, for a period of 30 days, the public are invited to submit written comments on the draft recommendations. FDA will then consider the public views and comments and revise the recommendations as necessary. So watch this space for further news on the fees for 2018 and beyond.
FDA reclassifies Eustachian tube balloon dilation systems
25 October 2016
The US Food and Drug Administration (FDA) has issued a final order classifying the Eustachian tube balloon dilation system from class III into class II (special controls). With effect from 24 October 2016, according to Federal Register Volume 81, Number 205.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval, via the 510(k) process.
In response to a request for reclassification under section 513(f)(2) of the FD&C Act, FDA determined that this type of device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Any firm submitting a premarket notification (510(k)) for a Eustachian tube balloon dilation system will in future need to comply with the special controls identified in the final order and repeated in new regulation 21 CFR 874.4180, 'Eustachian tube balloon dilation system'.
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