Regulatory Open Forum

Hi All,

Question: Are the changes associated with the UDI labeling requirements, considered to be changes in the Device? If so, is it expected that this would require the assessment outlined in the FDA guidance "Deciding When to Submit a 510(k) for a Change to an existing Device".

This would mean an LTF rationale for each product.

I think that this is not the case and that we should not treat the UDI labeling changes as product labeling changes.

Thoughts are appreciated

:)

The short answer is yes. The design output, in 820.3(g) says the total finished design output consists of the device, its packaging and labeling, and the device master record. Consequently a label change is a design change under 820.30(i).

Apply the 510(k) guidance. Start with the main flowchart. The answer to “Labeling Change?” is Yes, so go to flowchart A.

Answer Questions A1 to A4 with No.

Answer Question A5 with Yes, leading to Documentation.

Document your decision path with complete responses to the questions in the DHF section related to the label design change.

There is a section in the UDI Final Rule published in the Federal Register Vol. 78, No. 185 on 24 Sep 2013, in the preamble section DD on page 58807, dealing with the requirement for a submission related to the addition of a UDI to a device or device package.  The FDA provides the following guidance:

"The addition of a UDI to a device label or device package is very unlikely to require the submission of a 510(k) premarket notification or a PMA supplement.  the addition of a UDI to the label of a Class III device should generally be reported in the next annual report concerning the PMA of that device."  If the only change to a label was to add the UDI and no other content changes were required, it seems the guidance is clear.  If direct marking is a requirement for your device, the decision is not so clear and is also addressed in this section.

If a product change is made that results in a the requirement for a new device identifier (21CFR830.50), the scope of the change would have to be evaluated for a regulatory submission.

It would still be best to document a decision not to file a 510(k) referencing this section of the final rule in either the product DHF or through your Engineering Change/Document Change process to indicate the potential for a submission was at least considered.

Additionally, I contacted a notified body to ask the same question and was told that a substantial change notification was not required for adding a UDI to the product and package label with the same caveat above.  However not every notified body my have this same response since there is no NBOG guidance relating to this topic.

I hope this response is helpful.

The short answer is yes. The design output, in 820.3(g) says the total finished design output consists of the device, its packaging and labeling, and the device master record. Consequently a label change is a design change under 820.30(i).

Apply the 510(k) guidance. Start with the main flowchart. The answer to “Labeling Change?” is Yes, so go to flowchart A.

Answer Questions A1 to A4 with No.

Answer Question A5 with Yes, leading to Documentation.

Document your decision path with complete responses to the questions in the DHF section related to the label design change.

Hi All,

Question: Are the changes associated with the UDI labeling requirements, considered to be changes in the Device? If so, is it expected that this would require the assessment outlined in the FDA guidance "Deciding When to Submit a 510(k) for a Change to an existing Device".

This would mean an LTF rationale for each product.

I think that this is not the case and that we should not treat the UDI labeling changes as product labeling changes.

Thoughts are appreciated

:)

Hi All,

Question: Are the changes associated with the UDI labeling requirements, considered to be changes in the Device? If so, is it expected that this would require the assessment outlined in the FDA guidance "Deciding When to Submit a 510(k) for a Change to an existing Device".

This would mean an LTF rationale for each product.

I think that this is not the case and that we should not treat the UDI labeling changes as product labeling changes.

Thoughts are appreciated

:)

Hi All,

Question: Are the changes associated with the UDI labeling requirements, considered to be changes in the Device? If so, is it expected that this would require the assessment outlined in the FDA guidance "Deciding When to Submit a 510(k) for a Change to an existing Device".

This would mean an LTF rationale for each product.

I think that this is not the case and that we should not treat the UDI labeling changes as product labeling changes.

Thoughts are appreciated

:)