Updates to Common FDA Forms

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We recently posted about the August 2017 updates to common FDA forms included in eCTD submissions. Well, they’ve been updated yet again. Several FDA forms are now showing a revision date of April 2018, including:

  • Form FDA 356h
  • Form FDA 1571
  • Form FDA 3674

The easiest way to ensure that you’re using the current version of these forms is to download new copies directly from the FDA Forms page on FDA’s website.

If you already have copies and are trying to determine if they are the current versions, following is some information regarding what was changed on each of these forms.

Updates to Common FDA Forms

Form FDA 356h

There have been multiple edits to Form FDA 356h. New fields have been added and several existing fields were rearranged. The expiration date of March 31, 2020 remains unchanged, however.

FORM FDA 356h 15a and 15b

1. Box 15 was split into two new boxes, 15A and 15B. 15A collects the same info as the previous Box 15, “(Proposed) Indication for Use.”

2. Box 15B is a new field added to collect the “SNOMED CT Indication Disease Term.”

FORM FDA 356h items 21_27

3. Due to the addition of Box 15B to page 1, Box 21 shifted from the bottom of page 1 to the top of page 2, but remains otherwise unchanged.

4. An entirely new Box 24 was inserted into the form to collect information on combination products.

5. The previous Box 24, collecting pediatric and human factors data, is now Box 25.

6. Box 26 was resized and repositioned, but remains otherwise unchanged.

7. The “Reasons for Submission” were previously collected in Box 25. This field has been repositioned and renumbered as Box 27.

Due to the insertion of the new Box 24 on page 2, Boxes 27 through 29 were renumbered as Boxes 28 through 30. However, the contents of those boxes remain otherwise unchanged.

To identify this version of the form, look for the revision date of “(04/18)” in the footer of each page.

Form FDA 356h 4.18

Form FDA 1571

There were also several changes to Form FDA 1571, many of them matching the changes to Form FDA 356h. The expiration date of February 28, 2019 remains unchanged, however.

Form FDA 1571 items 6 and 7

1. Boxes 6A and 6B were expanded to fill unused space on the form, but remain otherwise unchanged.

2. Box 7 was split into 2 new boxes, 7A and 7B. 7A collects the same info as the previous Box 7, “(Proposed) Indication for Use.”

3. Box 7B is a new field added to collect the “SNOMED CT Indication Disease Term.”

Form FDA 1571 boxes 11_13

4. The options under the Protocol Amendment section were reorganized, but Box 11 remains otherwise unchanged.

5. An entirely new Box 12 was inserted into the form to collect information on combination products.

6. The previous Box 12, collecting data on emergency and expanded use, is now Box 13.

Additionally, due to the insertion of the new Box 12 on page 1, Boxes 13 through 27 on page 2 were renumbered as Boxes 14 through 28. However, the contents of those boxes remain otherwise unchanged.

To identify this version of the form, look for the revision date of “(04/18)” in the footer of each page.

 

Form FDA 1571 4.18

Form FDA 3674

The previous version of Form FDA 3674 was last revised in February 2015 and had an expiration date of February 28, 2018. The new version of this form shows a revision date of April 2018 and has an expiration date of March 31, 2021.

The new version of this form appears to have only two minor changes. First, the header on page 1 removed the reference to “(42 U.S.C. § 282(j))” following “ClinicalTrials.gov Data Bank.”

 

Form FDA 3674 header

 

Second, Box 10 on page 2 has been changed so that it initially may appear to have no fillable fields present to allow for the entry of NCT Numbers.

 

Form FDA 3674 box 10

 

Thanks to an alert colleague, I’ve learned that Box 10 only becomes fillable if you check Box 9C at the bottom of page 1.

To identify this version of the form, look for the revision date of “(04/18)” in the footer of each page.

 

Form FDA 3674 4.18

Conclusion

We recommend that you begin using the current versions of these forms immediately in all of your eCTD submissions. Using an outdated version of these forms could place your submission at risk of a technical rejection by FDA.

 

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Author: Evan Richardson

Evan Richardson brings over 10 years of experience in regulatory affairs and operations to Synchrogenix. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions and organizational training.

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