Drug-Led vs. Device-Led Combination Products: Determining the Primary Mode of Action (PMOA)
FDA 510(k) Submissions to Use eSTAR – Changes in FDA eSTAR Program
19 Oct, 2023
[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” border_style=”solid” margin_top=”0″ padding_top=”0px” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” hover_type=”none” border_style=”solid” border_position=”all” box_shadow=”no” box_shadow_blur=”0″ box_shadow_spread=”0″ padding_top=”0″ margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_direction=”left” animation_speed=”0.3″ filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true” min_height=”” link=””][fusion_imageframe image_id=”17112|full” custom_aspect_ratio=”100″ lightbox=”no” alt=”FDA 510(k) Submissions to Use eSTAR – Changes in FDA eSTAR Program” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” align_medium=”none” align_small=”none” align=”none” hover_type=”none” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title_tag=”2″ animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″ filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2023/10/FDA-510k-Submissions-to-Use-eSTAR-Changes-in-FDA-eSTAR-Program.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ title_link=”off” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” content_align=”left” size=”1″ text_shadow=”no” text_shadow_blur=”0″ text_stroke=”no” text_stroke_size=”1″ text_overflow=”none” gradient_font=”no” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ style_type=”default” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]
Writing a 510(k) for FDA eSTAR Program
[/fusion_title][fusion_text hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]Adapting your approach to writing a 510(k) to accommodate the new eSTAR requirements is no easy task. The days of writing a creative submission that tells a story of development, safety, effectiveness and substantial equivalence with a beautifully orchestrated flow are over. The old 510(k) format will not readily fit into the eSTAR template. FDA’s eSTAR is an interactive PDF template for medical device 510(k), De Novo, and PMA submissions. It generates thousands of pages, includes hover-over pop-up JavaScript Windows instructions, and requires tens of attachments depending on your device complexity.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ title_link=”off” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” content_align=”left” size=”2″ text_shadow=”no” text_shadow_blur=”0″ text_stroke=”no” text_stroke_size=”1″ text_overflow=”none” gradient_font=”no” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ style_type=”default” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]
Mandatory Use of eSTAR for Submitting 510(k)s
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Use of eSTAR for submitting 510(k)s became mandatory for the industry beginning October 1, 2023. Which is also when eCopy became unavailable for 510(k)s. De Novo and Premarket Approval (PMA) will remain eligible for eSTAR on a volunteer basis.
Following are five tips to help you transition to using eSTAR.
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Make Sure You’re EU IVDR Compliant
The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.
In other parts of the template, attachments are required. At least within the attachments, creative introductions can be added to help frame the story. The limited response options in the drop-down menus etc can be insufficient and stifle creative writing opportunities.
If this is your first time, be sure to register for a CDRH Portal account to send CDRH eSTAR premarket submissions online. This portal will allow you to track your submission.
Also, remember to submit your user fees at least two weeks in advance of sending in your eSTAR 510(k). This allows the FDA enough time to process your payment. If you are new to paying user fees and don’t understand the process, the FDA has created this handy guidance document to support you:
[/fusion_text][fusion_imageframe image_id=”17113|full” custom_aspect_ratio=”100″ lightbox=”no” alt=”FDA eStar Template – Celegence” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” align_medium=”none” align_small=”none” align=”none” hover_type=”none” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title_tag=”2″ animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″ filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2023/10/FDA-eStar-Template-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ title_link=”off” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” content_align=”left” size=”2″ text_shadow=”no” text_shadow_blur=”0″ text_stroke=”no” text_stroke_size=”1″ text_overflow=”none” gradient_font=”no” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ style_type=”default” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]#2: Prepare Your FDA eSTAR Template[/fusion_title][fusion_text hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]
Take time to explore the FDA eSTAR template to gain an understanding of what information and format each section entails. When you go into eSTAR, most fields for populating information are not visible until you begin making certain choices. For instance, one of the first things it asks is the type of submission: Traditional, Abbreviated or Special. Walk through the questions and provide answers to see what additional fields become visible to you. Create your own template outside of eSTAR accordingly.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ title_link=”off” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” content_align=”left” size=”2″ text_shadow=”no” text_shadow_blur=”0″ text_stroke=”no” text_stroke_size=”1″ text_overflow=”none” gradient_font=”no” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ style_type=”default” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]#3: Save your Work Outside of eSTAR[/fusion_title][fusion_text hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]
It is highly recommended that you completely populate your own template before loading it into eSTAR. This is because eSTAR does not save an editable version of your submission. By taking the time to save your own fully populated template you can use it as a starting point for future submissions as a lot of the data may stay the same. Especially if the reason for the next submission is modifications to the existing cleared device.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ title_link=”off” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” content_align=”left” size=”2″ text_shadow=”no” text_shadow_blur=”0″ text_stroke=”no” text_stroke_size=”1″ text_overflow=”none” gradient_font=”no” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ style_type=”default” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]
#4: Timing for FDA eSTAR Upload
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FDA has been issuing upgrades, as newer versions of the template, about every couple of months. When new versions are issued, older versions become obsolete, and you will no longer be able to upload them to eSTAR. It’s best to use your own template outside of eSTAR and only populate eSTAR when your 510(k) data is complete. Once signed as complete in eSTAR you cannot make any edits to attachments or the responses. Yes, you can provide additional information, but you cannot change what has been previously submitted.
[/fusion_text][fusion_imageframe image_id=”17114|full” custom_aspect_ratio=”100″ lightbox=”no” alt=”Timing FDA eStar Upload – Celegence” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” align_medium=”none” align_small=”none” align=”none” hover_type=”none” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”left” caption_text=”Full-text appraisal summary along with a custom set article appraisal criteria” caption_title_tag=”div” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″ filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2023/10/Timing-FDA-eStar-Upload-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ title_link=”off” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” content_align=”left” size=”2″ text_shadow=”no” text_shadow_blur=”0″ text_stroke=”no” text_stroke_size=”1″ text_overflow=”none” gradient_font=”no” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ style_type=”default” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]#5: Adjust your 510(k) Submission Budget[/fusion_title][fusion_text hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]
FDA announced FY2024 FDA User Fees on July 28, 2023. This announcement included huge price increases of 56% for 510(k) $21,760 or $5,440 for small businesses.
FDA 510(k) Submission Fees 2024
| Application Fee Type | Standard Fee | Small Business Fee |
| Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) | $483,560 | $120,890 |
| Premarket report (submitted under section 515(c)(2) of the FD&C Act) | $483,560 | $120,890 |
| Panel-track supplement | $386,848 | $96,712 |
| De novo classification request | $145,068 | $36,267 |
| 180-day supplement | $72,534 | $18,134 |
| Real-time supplement | $33,849 | $8,462 |
| 510(k) premarket notification submission | $21,760 | $5,440 |
| 30-day notice | $7,737 | $3,869 |
| 513(g) request for classification information | $6,528 | $3,264 |
| Annual fee for periodic reporting on a class III device | $16,925 | $4,231 |
| Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding or processing of a device, as defined by 21 U.S.C. 379i(14)) | $7,653 | $7,653 |
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FDA eSTAR Conclusions
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The eSTAR was developed with the purpose of streamlining and organizing the FDA’s review of premarket submissions. The eSTAR template creates submissions that are consistent by organizing the data in the same order each time and every submission answering the same direct questions. Overall, this should increase the FDA’s efficiency. However, the eSTAR format results in generating thousands of pages which is a significant increase from 510(k)s of the past.
The increase in pages in part contributes to the 56% increase across user fees. Time will tell if industry realizes benefits from eSTAR or if the benefits reside solely with the FDA.
[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” border_style=”solid” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ type=”1_1″ layout=”2_3″ center_content=”no” target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” hover_type=”none” border_style=”solid” border_position=”all” box_shadow=”no” box_shadow_blur=”0″ box_shadow_spread=”0″ background_type=”single” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_direction=”left” animation_speed=”0.3″ filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true” min_height=”” link=””][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ title_link=”off” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” content_align=”left” size=”4″ text_shadow=”no” text_shadow_blur=”0″ text_stroke=”no” text_stroke_size=”1″ text_overflow=”none” gradient_font=”no” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ style_type=”default” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]eSTAR FDA Submission Specialists[/fusion_title][fusion_text hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″]Celegence provides regulatory strategy consulting and can help you navigate the complexities of FDA guidance interpretation and FDA interactions. If you need any assistance with eSTAR FDA submissions then reach out to us at info@celegence.com or contact us online for more information.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” border_style=”solid” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ type=”1_1″ layout=”2_3″ center_content=”no” target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” hover_type=”none” border_style=”solid” border_position=”all” box_shadow=”no” box_shadow_blur=”0″ box_shadow_spread=”0″ background_type=”single” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_direction=”left” animation_speed=”0.3″ filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true” min_height=”” link=””][fusion_text rule_style=”default” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” animation_direction=”left” animation_speed=”0.3″]
Make Sure You’re EU IVDR Compliant
The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.
AUTHORED BY
Celegence
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