FDA Unique Device Identifier SW Requirements.

FDA issued its final rule September 24, 2013 along with a Draft GUDID Guidance. The link attached is FDA’s webpage related to this rule. It includes a table of compliance dates ranging from 1 to 7 years depending on device class and type.

A unique device identifier (UDI) is a combination of a Device Identifier (DI) and a production identifier (PI). The device identifier is assigned by either the FDA or an FDA accredited issuing agency. For stand alone software, the PI is your version number. The rule designates that when dates are used, they should be of the format YYYY-MM-DD when used.

The following steps should be taken for labeling your devices in order to comply with the Medical Device Unique Identifier Rule:

1. Obtain a DI from an FDA accredited Issuing Agency or FDA (Note: We are not aware of any FDA accredited Issuing Agencies at this time.)

2. Need a GUDID (Global Unique Device Identifier Database) Account. This is an FDA account. (Note: This account is not yet available that I am aware of.)

3. For Stand alone software that is not packaged a plain-text statement of the UDI is to be displayed whenever the software is started, or a plain-text statement to be displayed through a menu such as with an “about” command.

4. For Stand Alone Software that is packaged, the package label and the label of the CD or other medium should additionally include an AIDC UDI number. An AIDC is as automatic identification and data capture technology that conveys the UDI in a form that can be entered into an electronic patient record or other computer system via an automated process (e.g., barcode).

This regulation additionally requires the UDI to be reported as part of a recall/MDR event and may require you to update those procedures.

This represents highlights of our understanding of the rule at this point in time. FDA interpretation, enforcement and final guidance is variable and may change over time.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

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