The US Food and Drug Administration (FDA) has proposed revisions to thede novo pathwayin order to make medical device classification more efficient and transparent.
新创通路用于再保险view new, low-to-moderate risk devices and determine predicates that assure certain safety and effectiveness measures.
The regulatory agency has published the new de novo Classification Proposed Rule involving procedures and criteria associated with the process. The rule is intended to enable ‘appropriate’ classification of new types of medical devices.
Specifically, the revision offers structure, clarity and transparency on the format and content of de novo requests, and the processes and requirements for acceptance, declining and withdrawal of the requests.
The move comes shortly after the食品及药物管理局宣布现代化医学德维克e 510(k) clearance pathway.
“Our aim is to make the de novo pathway remarkably more well-organised and transparent by making clear the requirements for submission and our processes for analysis. As a result, we wait to see more developers take the lead of the de novo pathway for novel devices.” says the FDA commissioner.
FDA 510 k Clearance & Premarket Approval for Medical Device
Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities.
Contact Us WhatsApp“The proposed regulation we’re issuing today-as well as those steps that we announced last week will help the FDA regulate new technologies in ways that enable us to protect patient safety while promoting innovations that can advance peoples’ health and function.”
The regulatory agency also formally recognized a public database called ClinGen Expert Curated Human Genetic Data, which comprises information on genes, genetic variants and their relationship to disease.
This is expected to enable the development of new, beneficial genetic tests. Developers will be able to use the information in the database to support the validity of their tests, rather than generating data on their own.