Presbyopia Optana
Medical Device Approval
CE and FDA approval
European CE approval
The medical approval of devices in the European Community is clearly regulated by the medical device directive MDD 93/42/EEC.
Here the generation of a product document i.e. a device file is demanded. Those among other things must contain a detailed description of the developing process, compliance and elaboration of device-specific standards and the risk analysis. Nevertheless, the successful clinical evaluation, possibly including ethics commissions and qualified physicians, is an indispensable condition for the approval of the product.
With submission of this device file to the notified body OPTANA is authorized to mark the respective products with the CE label and to offer the products for sales.
Already several times OPTANA provided device files and extensively is familiar with the necessary specific medical requirements, in order to be allowed to sell devices without any problem in Europe.
US-American FDA approval
The approval of medical devices in the US is centrally processed by the Food and Drug administration (FDA) and requires the fulfilment both national standards and of the FDA defined "Guidelines for industries". All documents of evidence for this are to be furnished in English language and after a firmly given operational sequence/course of action.
Additionally to the registration proceedings production is supervised after the guidelines of the QSR (quality system regularization) by FDA examiners and documented in audit reports.
OPTANA knows the necessary procedures to approve products in the USA and cooperates with partners in the US experienced with FDA approvals.
