FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission.
This document is intended to cover:
▪️ firmware and other means for software-based control of medical devices;
▪️ stand-alone software applications;
▪️ software intended to be operated on general-purpose computing platforms;
▪️ dedicated hardware/software medical devices; and
▪️ accessories to medical devices when those accessories contain or are composed of software.
This guidance applies to all types of premarket submissions that include one or more device software function(s).
Comments can be submitted till February 2, 2022.
Consult the FDA guidance.
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This article provides general information and does not constitute regulatory, legal, clinical, or compliance advice. Requirements and appropriate processes may vary by study, product, jurisdiction, and organization. Medigen Suite functionality should be used in accordance with applicable regulations, study documentation, and internal procedures.
