US FDA, Drug-device and biologic-device combination product sponsors bridging data draft

US, FDA issued a draft guidance in regards to how drug-device and biologic-device combination product sponsors can bridge data from earlier stages or development or other development programs to support an application.

The 14-page guidance gives a detailed explanation on how sponsors are able to derive an analytical framework for the identification of information gaps that could be addressed with bridging.

It also provided 3 concrete examples for references.

This guidance is scheduled for finalization by the end of 2022.

More details are in the link.

https://www.fda.gov/media/99140/download

US, FY 2020 draft and final guidance list

US, The FY 2020 draft and final guidance list was released by FDA’s Centre for Devices and Radiological Health (CDRH). The new drafts includes coming on device servicing and remanufacturing, unique device identification and patient-reported outcome measures used in device submissions alongside others. The list is divided into 2 parts “A List” being priority and “B List” of less.

More details are in the link.

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2020-fy-2020#a

 

US, FDA exemption of additional class II medical devices

US, FDA proposed the exemption of additional class II medical devices under 5 different product codes from 510(k) requirements. The exemptions followed in accordance to the finalization of a list back in July 2017 of 1,003 types of class II devices that the agency also said do not present risks that require premarket notification. FDA has limited the exemptions to certain devices within that specific product code for 4 out of the 5 product codes proposed.

More details are in the link.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-23308.pdf