Some great news on ISO Certification 13845 & that is a BIG necessity for for Regulatory Approval. I wouldn’t go cutting your arm off over no news on FDA as yet. It’s a pre-submission guidance meeting for Regulatory Pathways, De Novo, 512K & possibly other, CDx. We also may have been recommended to go down the Breakthrough Device Designation pathway: (MCIT/CMS). A thirty day turn around for an answer on that (BDD).
There are rules on FDA pre-sub meetings & also rules on timeframes as to meetings & when they should occur. They are within that 10 week time frame & from memory, at the 6 week mark a mutual date should have been negotiated for a meeting. So....
That’s my general gut feeling, waiting on Janssen (J&J) We need ISO for IVDT & that has been confirmed today, & will reflect across future developed tests by the company. Always expected they would achieve this, for PIQ as a company. They (PIQ) received first ISO for Proteomics globally.
Well done PIQ! Have a great weekend all & a bit of Black comedy for tonight.
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