Electronic Products
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. Your identity and other personal information can be stolen from a computer, cell phone, or other data storage devices. Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date (e.g., § 58.130), time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries. Records that are required to be mai