Off-The-Shelf Software Use in Medical Devices
This guidance document represents the agency’s current thinking on the documentation that should be provided in premarket submissions for medical devices using OTS software. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations or both. The FDA uses mandatory language, such as shall, must, and require, when referring to statutory or regulatory requirements. The FDA uses non- mandatory language such as should, may, can, and recommend when referring to guidance.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.