DE NOVO - FDA Risk Based Classification?5 Oct 2022 11:38
Am I reading this correctly, if it’s risk based then FDA have to approve if company demonstrates the risks are safely controlled?
In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over US$1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage.
David Budd, CEO of genedrive plc, said: "The US is a particularly attractive market for this unique test given the potential to save hundreds of individuals from life-long deafness and reduce litigation costs relating to the unwanted side effects from antibiotic use on those carrying the gene variant. Either an FDA 510(k) clearance or the granting of a De Novo request is required to allow us to market this test in the US. Ultimately, we feel that the US market is potentially the most attractive market given its size, birth rates, use of diagnostic testing and reimbursement structure."
A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). The De Novo pathway provides a vehicle for establishing new predicates that can reflect modern standards for performance and safety and can serve as a basis for future clearances. De Novo classification is a risk-based classification process used when there is a lack of predicate device already cleared by the FDA.
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