CDRH Portal Overview and Feature Walkthrough

Slide 1

[Andrew Sprau] Hello. Welcome to CDRH Learn, our program series for multimedia education for 

medical devices and radiological health products. In this module, we'll provide an overview of the CDRH 

Portal and walk through of some of its features. Your presenter for this module is Nelson Anderson, 

CDRH Portal platform owner from the Office of Regulatory Programs in the Office of Product Evaluation 

and Quality within the Center for Devices and Radiological Health.

Slide 2

[Nelson Anderson] The medical device industry has been asking for a way to electronically submit their 

applications to us. And we have heard that and created this CDRH Portal, which allows both electronic 

upload of submissions and tracking of some of those same submissions.

Slide 3

Please note that the CDRH Portal is an evolving program and continually is enhanced throughout the 

year. So, some of the information in this presentation may be somewhat out of date by the time you 

view it. If you want the most up-to-date information, please see the Portal Help articles that are inside 

the portal itself.

Slide 4

Our objectives today are to describe the purpose of the CDRH Portal, to discuss what submissions can be 

uploaded through the portal, and to discuss which submissions can be tracked in the portal. 

Slide 5

So first of all, what is the CDRH Portal? The CDRH Portal, otherwise known as the Customer 

Collaboration Portal, is a secure website that allows the medical device industry to upload CDRH-led premarket submissions directly to CDRH and allows them to track the progress of supported pre-market 

submissions. 

Slide 6

So first, we're going to talk about uploading files through the portal.

Slide 7 

We frequently get the question, well, what can we upload through the CDRH Portal? And the answer is 

pretty straightforward. Anything that is typically mailed to the CDRH Document Control Center, 

otherwise known as the DCC, can be uploaded through the portal. That makes it simple and 

straightforward.

Also, our uploads are limited to a size of 4 gigabytes. Now, if you're concerned about whether that 4 

gigabytes might be a constraint, please consider the current average size of an upload through the 

portal is right around 55 megabytes. And to date, the last roughly quarter of a million submissions that 

have come to CDRH, which is about 10 years’ worth, 99.9% of those submissions have all been lower 

than 4 gigabytes. So, this size restriction should not be a problem for most of our submitters. 

Nothing physical needs to be sent in for a file uploaded through the portal, which hopefully is fairly 

logical. Our eCopy guidance does currently specify that if you send an eCopy through the mail, you do 

have to print off a cover letter and sign that cover letter, but that only applies to the ones that are sent 
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through the mail. If you upload an eCopy through the portal, you do not need to include the printed 

cover letter. 

Slide 8 

However, speaking of cover letters, they are still very important for uploads through the portal. So, 

unless it's an eSTAR format, which includes information in it, everything else should have a cover letter 

attached in PDF format somewhere in that upload. The cover letter is used by our DCC to determine the 

purpose of the submission and how it should be processed. If they do not have a cover letter and the 

DCC is not clear on what that upload is, it could cause delays in the processing of that submission. And it 

may not get to the reviewers or to whomever it's supposed to get to in an expedient manner. So, 

providing a PDF format and cover letter in your eCopy is very important for making sure your things 

occur efficiently. 

And while there are no file name requirements for file uploads through the portal, logical file names are 

another thing that help our DCC identify the file and process it quickly. For example, if you name your 

submission K23####AIresponse.zip, as soon as the DCC sees this, they are going to know this is related 

to this specific 510(k). It's an AI response, so I know it's going to be a supplement. So, before they even 

open it and get to the cover letter, they know what to do with it, and that's just going to help them be 

more efficient. 

Now, this last point is really important. So, some users presume that, as soon as they upload something 

to the portal, it has been received by FDA. And we have certain workflows, say additional information 

response to a 510(k), that have a response due date. And so potentially, a user might say, hey, today is 

the response due date, but it's before midnight, as long as I upload my file before midnight, I have met 

the response due date. 

Well, that is not correct. So, we have a cutoff time every business day for when any file that is received 

in the portal will be processed. And that is 16:00 Eastern. For example, if you upload something at noon 

Eastern time on Friday, it will be processed on Friday. The DCC will get it. They'll process it. It will be 

officially received by CDRH on Friday. However, if you upload that same submission at 18:00 Eastern, it 

has missed the 16:00 Eastern cutoff point and will not be processed on Friday. It will be processed the 

next normal business day. Well, of course, the DCC does not work on weekends. So, it will not be 

processed on Saturday. It will not be processed on Sunday. It will be processed on Monday, unless, of 

course, Monday is a federal holiday and then it will be processed Tuesday morning. So potentially, by 

missing this cutoff date on a Friday, your submission may not be officially received by CDRH until 

Tuesday morning Eastern time. So please keep this in mind when you are uploading. Don't wait until the 

last minute to upload something to us. Do it ahead of time. Do it the day before. Then you don't have to 

worry about missing the cutoff time. 

Slide 9 

For the most part, all submissions through the portal should be a single file. So, you should be either 

uploading one single ZIP file for an eCopy or one single PDF for an eSTAR. Now, there are some 

circumstances, third party eSTAR, where you have the eSTAR and the third-party documentation, or 

potentially an eSTAR that also has statistical data, or has a bunch of proprietary images that have to be 

sent separately, that can't be attached. So, there are sometimes when you actually need to split it up. 
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We have instructions in the portal on how to do that, and I'll show you that later. But for the most part, 

your submission should be one single file that you're uploading. You shouldn't be breaking it up into 

multiple pieces. Just one ZIP file or one PDF. And this is a reminder that, starting on October 1st, 2023, all 

510(k)'s must be submitted in eSTAR format and they should come through the portal as long, of course, 

as they are under 4 gigabytes. 

Slide 10

Now, we're going to switch over to talking about tracking submissions. So, currently in the CDRH Portal, 

it supports the progress tracking of traditional, special, and abbreviated 510(k)s, as well as all presubmissions. There are only two types of pre-submissions, which is written feedback and meeting 

request. 

The tracking of a submission is initially only available to the official correspondent on record. And if 

you're wondering who the official correspondent is, there is a help article inside the portal that 

describes exactly how we determine who the official correspondent of record is. But initially, again, that 

submission can only be tracked by the official correspondent. But the official correspondent can share 

the progress tracking with other portal users. For example, if there is a consultant who is the official 

correspondent on a 510(k), they can then share that tracking information of the 510(k) with the sponsor 

of the 510(k), presuming, of course, that the sponsor has self-registered for a portal account. 

Slide 11

Next, we're going to talk about where you can get help or more information about the portal. 

Slide 12

So, the primary place to find out more information about the portal is in the Portal Help System, which, 

of course, is inside the portal itself. It has answers to many of the common questions that we get, and it 

has a What's New section that includes instructions on how to use all of the newly added features, such 

as the progress tracking share with others that I mentioned. 

You don't need any sort of invitation to get a portal account. You can self-register for it. And to find the 

links to the portal, or to the self-registration that I just mentioned, simply do a web search for “FDA Send 

and Track”. Generally, the very first search result will be our web page and you can use the links right off 

of that web page. 

Slide 13

Now, we're going to go ahead and take a look at the portal itself. So, what you see here is the home 

screen of the portal. This is what you see when you log in and the first thing I'm going to mention is the 

Portal Help, of course. Portal Help is the question mark down in the lower left-hand part of the screen 

there and 

Slide 14

that will give you a new tab, and as I mentioned previously, there are two sections, the Common 

Question sections, which has answers to the most common questions, of course, and the What's New 

section that will tell you new features as they come out. It'll also give you instructions on how to use 

those new features. 
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Slide 15

Going back to the home screen, this top portion here is the Progress Tracking section of the CDRH 

Portal, and it is going to list all of the 510(k)'s and/or pre-subs for which you are the official 

correspondent or have been shared with you. And there's a little bit of information that is shown here 

just to give you a summary, so you know what that submission is, its general progress, and the goal date, 

how many days are left. Just here from your dashboard. So, you can see this 510(k), which is listed is On 

Hold. It is a traditional 510(k) and the goal date, which is June 20th, 2023, is the date by which I need to 

respond to CDRH because they asked me questions. So, it's saying, hey, your response due date is in 84 

days. So, that's what I can get just off of looking at the simple bit of information. If I want the details, I 

can click on the 510(k) number here and that will move me to a details screen. 

Slide 16

Slide 17

So here we are in the details screen, and up here in the left corner, we see that, again, this notes it’s a 

traditional 510(k) and gives the 510(k) number. Below that, we have some general administrative 

information; we have the company name, the device name, and then we have where in the FDA that 

this is being reviewed, including the office, the division, the team, and the lead reviewer name. The lead 

reviewer name will also generally include their email address listed under it. 

In the top status section, we have a quick status statement, reviewing. We are reviewing this medical 

device. so that's just to let you know it's not on hold, it's under review. The progress bar gives you a 

general sense of how far through the review this submission is. And in this case, this is just a day count, 

so a traditional 510(k) generally takes 90 days, is the MDUFA commitment. This is on day 28, so this bar 

is roughly one third full. It notes the FDA start date, and it notes the FDA presumed MDUFA decision 

date. So, this is a predicted date for the MDUFA decision, which again should be by 90 days. So, it's just 

predicting this should happen by 90 days. It's not a guarantee it will, it's just when it should happen. 

Next, we have a couple of statements up here at the top. The important one I want to mention here is 

all records are updated overnight. So, the portal does not track in real time, it just gets nightly updates. 

So don't log into the portal multiple times a day trying to see if something has changed or if the status 

has somehow been updated because it won't. It's only going to update once per night. The other thing 

to mention about that is if you receive an email from CDRH with an official recommendation. Say we've 

sent you an SE on your 510(k), that is not going to be reflected on the portal until the following day. So, 

if you get the SE letter today and you go into the portal, it will not show the SE decision, but if you check 

the portal tomorrow, it will show the SE decision. 

Then below that, we have milestones here. So, this just gives you a sense of what has occurred with a 

submission from when we receive it to future predicted dates. So, the substantive interaction is in the 

future we are predicting when that should occur. And the final decision, again, estimated, this is a 

MDUFA date in the future, so we give some predictive dates in the future as well. 

Now, we have service time here. This is generally the time that has passed for the submission. In this 

case, it's pretty straightforward since it hasn't been on hold, it's been under review for 28 days and it 

has 62 days left to meet the 90-day MDUFA commitment. And then the last section is just the official 

correspondence contact info. 
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Slide 18

Now, back to the home page of the portal, this next section is for the uploads or the sent submissions. 

And in this case, you see it says you haven't sent anything yet. So, this particular user has not uploaded 

anything to CDRH. 

Slide 19

If something had been uploaded, you would see it listed on screen similar to this. So, under the Your 

Sent Submissions, it's going to list the file name that was uploaded, it's going to list the format type, so 

whether it's an eCopy or eSTAR, and then it's going to list the date and time that it was sent to the FDA. 

Slide 20

So, how do you send something using the portal? Well, you can either click on Send a Submission, those 

words there. Or after you send something, that wording will disappear, and you'll need to use the plus 

sign over here on the left-hand side. Now, clicking on either of those is going to open a new tab in the 

portal. And that will be the Upload Workflow.

Slide 21 

So here, we have our Send a Submission tab, and first, you'll note that over on the right is an info panel. 

And this information panel gives you some extra information that might be relevant to your first-time

sending submission. So, if you're not familiar with eSTAR, we have a link to the eSTAR home page, and 

then the instructions I mentioned previously about sending an eSTAR and another file, say a statistical 

CDISC package, third party memo, some DICOM images, something like that, if you click on View More, 

that would give you the instructions on how to go about that. Those same instructions are also in the 

Portal Help articles as well. 

For eCopy, we have a link to the eCopy guidance, in case you're not familiar with how to format 

something in the eCopy format. We have some additional resources, such as FDA Device Advice and 

some contact email addresses. So, for general questions, you'd want to contact DICE. For submissionspecific questions, you'd contact OPEQ Submission Support. And for anything related to the portal itself, 

CCP@fda.hhs.gov. Now, if you don't need this information panel, you can just click on the arrows up in 

the right-hand corner, and it will happily go away.

Slide 22

Now, of course, if you want that information panel to come back because you need an email address or 

something, you can just click on the “I” up there in the corner and the information panel will slide back 

out. So, let's go ahead and talk about actually sending the submission. So first, you're going to decide 

what format you're going to use, and that's going to be either an eSTAR or an eCopy. We're going to 

select eCopy today. 

Slide 23

So, you can see here it says, Send Your eCopy. So, it knows that we're sending an eCopy. And I'll note, as 

mentioned earlier, this has the send a submission before 16:00ET. It has the cutoff message. So, you'll 

see this on most of the screens, just to remind you what that cutoff time is. 

Now, for the file selection, obviously, you have to upload your own file. So, you can drag and drop it 

directly here in this box or you can browse for it. Clicking Browse will open the typical Windows Explorer 

window, and then allow you to select some ZIP file. Now, it's not going to allow you to select other file 
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types because, of course, this is an eCopy, it only allows ZIP files. Once you select that, it's going to 

switch and start uploading. 

Slide 24

So here, you can see we're on the upload process, and it shows the progress as the upload continues.

And the only option you have while you're uploading is to stop the upload. So, say you realize, oh wait, 

this is a compendium of all my pet cuttlefish photos, not my 510(k), I should stop this upload, you have a 

way to stop the upload and then you can select a different file if you need to. 

Slide 25

Once the upload is complete, you'll see this confirmation screen and it shows you the file name that was 

uploaded. And now, you have a couple of different options here. You can cancel the submission. So, if 

you realize, wait, this is, we need to change something in our 510(k), I don't want to upload it all right 

now. Canceling the submission allows you to close that tab, you're done with uploading at that moment. 

Again, if you realize, wait, I just uploaded my cuttlefish pictures, I need to select the actual 510(k), you 

can select a different file, but if everything looks good, then you just click on Send. 

Slide 26

And that takes you to the sent to FDA confirmation screen. Now, you'll notice, again, as I mentioned, it 

says sent to FDA, not received by FDA. And it gives you the date and time stamp and the file name that 

you uploaded. It also gives you some general expectations of what should come next. 

So as the uploader, you'll get an email that notes the same information, file name, date, and time of 

upload. And then the official correspondent, which may or may not be the same as the uploader, will get 

another email from the document control center when this submission is processed. This is what the 

email looks like that the uploader would get, again containing the file name and the date and time of the 

upload. 

Slide 27

So, in summary, the CDRH Portal can be used to track the progress of 510(k)s and pre-submissions, and 

any submission that is generally mailed to the CDRH Document Control Center can also be uploaded to 

them directly through the CDRH Portal. Thank you. 

Slide 28

[Andrew Sprau] We in the Division of Industry and Consumer Education provide you with regulatory 

education in several key formats, so you can choose the most effective way you wish to learn. CDRH 

Learn consists of over 200 multimedia industry education modules, such as the one you're watching 

here. These include videos, webinars, presentations, and various how-to guides. Use your computer, 

phone, or portable device to click on the link shown here, www.fda.gov/CDRHLearn.

Now, if you prefer to learn by reading, then we encourage you to check out Device Advice. Device 

Advice consists of several hundred pages of comprehensive regulatory information across the device 

total product life cycle. And finally, if you have a specific question in which to ask us directly, I encourage 

you to call or email us at the Division of Industry and Consumer Education. Our contact information is 

listed here, 1-800-638-2041 or email at DICE@fda.hhs.gov. And we look forward to speaking with you. 
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Slide 29 

Let's conclude this module with your call to action. First, use the CDRH Portal to upload your submission. 

No need for you to mail your eCopy or eSTAR. And second, track the progress of your submission by 

using the Progress Tracker. This is a great way to get almost real-time status of your submission. Thank 

you for your attention to this CDRH Learn module, CDRH Portal overview, and feature walkthrough. 

We'll see you next time.

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