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FDA Action-Item List Shows Plans To Revamp De Novo, Combo Product, QSR Regs, And More

Executive Summary

Planned US FDA actions on the spring 2020 Agency Rule List show expected rules around de novo applications, and combination product classification and appeals – as well as the long-awaited Quality System Regulation overhaul.

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News We’re Watching: UK Software Guidance, FDA Approvals, Halyard Mask Warning

Abbott landed a surprise US FDA approval for the FreeStyle Libre 3 glucose monitoring system. Also this week: updated guidance documents on software (UK) and angioplasty catheters (US), FDA clearances for Candesant and Moximed, new regulatory requirements for spinal spheres, and a warning on Halyard masks. 

FDA Sets (Another) Deadline For Releasing Draft Harmonized Quality System Regulation

October 2020 is the new in-house target date for the US agency to release a draft of its revised QSR, which will be harmonized with international quality systems standard ISO 13485.

Minding The Middle: FDA Fleshes Out De Novo Regs As The Program Expands

A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.

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