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FDA UDI and GUDID Compliance Solutions

The UDI deadline for Class I devices passes in

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FDA UDI and GUDID Compliance Solutions

Under the FDA Unique Device Identifier (UDI) rule, most medical device labels and packages must bear a UDI.  The device labeler must apply the UDI and submit device information, including a device identifier (DI), product codes, and other characteristics to the Global Unique Device Identification Database (GUDID).

The UDI deadlines for most devices have passed.

Get Expert Assistance

Registrar Corp’s Regulatory Specialists can guide you through FDA UDI and GUDID requirements.

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  • Food Safety

    Is your Food Safety Plan FDA-Compliant?

    U.S. FDA requires most types of registered food facilities to implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans. A HARPC plan must follow unique standards mandated by U.S. FDA. Other food safety systems may not completely satisfy FDA requirements.

  • Food Safety

    U.S. FDA requires most types of registered food facilities to implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans. A HARPC plan must follow unique standards mandated by U.S. FDA. Other food safety systems may not completely satisfy FDA requirements.

  • Food Label Deadline

    Deadline Approaching for FDA's New Label Rules

    Many food companies have less than 12 months to update their labeling to comply with new FDA labeling rules. The new rules include updates to the nutrition facts chart, serving sizes, mandatory declarations, and more.

  • Food Label Deadline

    Labeling mistakes result in more than 22% of all detentions in the United States.

    Many companies do not realize their labels are non-compliant until their products are detained, which may result in delays, re-labeling expenses, or destruction of inventory. Help avoid costly issues in port. Have Registrar Corp's experts assess the FDA compliance of your labels.

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                            What is a UDI?

                            A UDI is a human-readable and machine-readable code used to identify a specific medical device from a specific device labeler.  Numbers in parentheses delimit meaningful aspects of the numeric or alphanumeric code.

                            Two main components define a UDI:

                            Device Identifier (DI)

                            A DI defines the labeler as well as the device version or model.  The DI is used as a primary key to reference this information in GUDID.

                            Production identifier (PI)

                            A PI defines characteristics such as:

                            • Manufacturing / Production Date
                            • Expiration Date
                            • Batch / Lot Number
                            • Serial Number

                            Steps to UDI Compliance

                            DUNS
                            1. Obtain a DUNS number

                            A device labeler complying with UDI requirements is required to have a DUNS number, which is used to identify the labeler in GUDID.

                            Regulatory Contact
                            2. Appoint A Regulatory Contact

                            FDA requires device labelers to designate a point of contact for device information. This Regulatory Contact ensures that required UDI information is submitted to FDA via GUDID.

                            UDI Package
                            3. Gather Your UDIs

                            UDIs have a device identifier (DI) and a production identifier (PI). The DI must be issued by an FDA accredited agency. The PI is determined by production information, such as the lot or batch number. A separate UDI is needed for every version or model of each device.

                            GMDN
                            4. Identify GMDN codes

                            Device labelers are required to identify a Global Medical Device Nomenclature (GMDN) code for each device submitted to the GUDID. A GMDN code represents an international standard for describing a specific device.

                            GUDID
                            5. Submit Device Information to GUDID

                            UDIs and all required device information must be submitted through to FDA through GUDID.

                            How Many UDIs Are Necessary?

                            A single device type needs a separate UDI for each different device characteristic, including:

                            Size • Color • Material • Style • Packaging

                            For example, a company manufactures examination gowns…

                            UDI Product

                            Each gown comes in three sizes

                            UDI Product
                            UDI Product
                            UDI Product

                            Each size comes in two colors

                            UDI Product
                            UDI Product
                            UDI Product
                            UDI Product
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                            UDI Product
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                            UDI Product

                            Each gown has a pocket style option

                            UDI Product
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                            UDI Product

                            Each type of gown is sold in packages of 50 and 100

                            UDI Product
                            UDI Product
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                            UDI Product

                            Considering all possible combinations:

                            3 Sizes x 2 Colors x 2 Styles x 2 Package Types

                            24 UDIs are necessary for the examination gowns.

                            Registrar Corp Makes Compliance Easy

                            Registrar Corp offers simple, low-cost solutions for FDA UDI and GUDID requirements.

                            Get Expert Assistance Now

                            Choose Registrar Corp for:

                            One-on-one guidance from a regulatory specialist

                            Guidance on required data

                            Submission-ready data for your device

                            Submission of your UDIs to GUDID

                            Solutions

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                            FDA has cancelled thousands of registrations that were not properly renewed or did not include
                            an accurate Unique Facility Identifier (UFI). If you need immediate assistance, Registrar Corp can help.

                            Notice: Medical Device and Drug establishments that did not renew their FDA registrations in   must re-register.


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                            FDA-registered facilities must renew their registrations by December 31,  

                            Medical Device and Drug establishments must renew their registrations by December 31,  

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                            Reminder

                            The U.S. Food and Drug Administration (FDA) requires that all registered food, medical device, and drug facilities renew their FDA registration between October 1 and December 31,

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                            Notice

                            The U.S. FDA Registration Renewal period CLOSED on December 31,

                            If you did not renew by the deadline, you must re-register with FDA.

                            Re-register or verify that your registration was renewed for :

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