Contribuiamo al successo delle aziende di Dispositivi Medici e Diagnostici in Vitro negli Stati Uniti ed in Europa
Siamo esperti riconosciuti nella gestione di studi clinici su Dispositivi Medici, IVD e Combination Products in Europa, Stati Uniti e Canada.
Da oltre 20 anni Donawa Lifescience Consulting (DLC) offre consulenza regolatoria specializzata
ed altamente qualificata nel settore dei Dispositivi Medici, inclusi i Combination Products
e gli ATMPs (Advanced-therapy medicinal products). DLC può
agire inoltre come mandatario europeo (Authorized Representative) per fabbricanti con sede legale extra europea.
Diagnostici in Vitro
Diagnostici in Vitro
Da oltre 20 anni Donawa Lifescience Consulting (DLC) offre consulenza regolatoria
specializzata ed altamente qualificata nel settore Dispositivi Medici,
inclusi i Diagnostici in Vitro (IVD). DLC può agire inoltre come
mandatario europeo (Authorized Representative) per fabbricanti con sede
legale extra europea.
Esistono molte differenze tra le normative europee e statunitensi sui
Combination Products e i dispositivi drug-delivery. Donawa Lifescience
Consulting ( DLC ) puo fornire consulenza strategica per identificare
tali differenze così da permettere il raggiungimento delle varie
tappe dello sviluppo del prodotto nel rispetto dei tempi previsti.
2019 FDA User Fees announced
22 August 2018
The US Food and Drug Administration (FDA) has announced small increases in user fees for fiscal year 2019, with the new fees, coming into effect on 1 October 2018, being:
* Note:all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
** For small businesses with an approved SBD.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Commission issues 'Fact Sheets' on MDR and IVDR Transitions
25 July 2018
The European Commission (EC) has issued two 'Fact Sheets' to assist manufacturers in the transition from the Medical Devices and Activive Implantable Medical Devices Directives (MDD and AIMDD) to the Medical Devices Regulation, and also from the In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostics Regulation (IVDR).
The Fact Sheet for the MDR explains that during the transitional period, the MDR will come into force gradually, starting with the provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the MDR, and that the transitional period will end on 26 May 2020, the “Date of Application” (DoA) of the Regulation. A similar explanation is included in the Fact Sheet for the IVDR.
The remainder of the documents explain the major changes and consequencies of the new legal requirements, as well as details of what is and what is not allowed during the transition periods leading up to full implementation and beyond.
At the same time, the EC has issued 'Implementation Models' for the MDR and IVDR, providing a step-by-step guide to how manufacturers should manage the transition from the Directives to the Regulations.
One further document was published on the EC website at the same time, this being an exhaustive list of manufacturer's obligations under the MDR, developed by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
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