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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance will assist industry and Agency staff in determining when a software (including firmware) change to a medical device may require a manufacturer to submit and obtain FDA clearance of a new premarket notification (510(k)). This guidance is not intended to implement significant policy changes to FDA’s current thinking on when submission of a new 510(k) is required for a software change to a 510(k)-cleared device (or group of devices) or other device subject to 510(k) requirements, such as a preamendments device or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the Food, Drug, and Cosmetic Act (FD&C Act) (also referred to together as “existing devices”). Rather, the intent of this guidance is to enhance the predictability, consistency, and transparency of the “when to submit” decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision, specifically as it relates to software changes.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-2021.