Since the MDR / IVDR deployment, EU and Swiss MedTech companies clearly see the opportunity of obtaining an approval of their products for sales in the USA
Medidee Services is a leading MedTech consulting firm with services ranging from strategy build up and tactical support down to field implementation of US regulatory requirements.
We propose strategies for quickly evaluating your products in terms of classification (I, II, III).
Our US team is installed on the East Coast, in Horsham, PA, as well as in Ohio.
FDA approval: reaching the US market
There is a significant difference in terms of requirement and duration of the procedure depending on the product class.
If the product is US class II and is supported by solid predicate devices, the procedure can be significantly simpler than for a class IIa / IIb under MDD / MDR. Therefore, our first task is usually to confirm the existence of predicates by screening the FDA database.
From there, our mission can either be to support the preparation of a 510k package, or to plan and guide the Client through the De-Novo process which applies to Class II without convincing predicates.
For class III, Medidee helps the Client in the development of a clinical strategy, probably including the setup of an IDE (Investigational Device Exemption) as building block of a PMA procedure.
Medidee organises the interaction with the FDA, especially when pre-submission meetings are of added value. Indeed, as opposed to Notified Bodies, the FDA is very approchable providing meeting are correctly prepared with precise questions.
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Do you need to support for preparing an FDA strategy ?
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