Quick Answer: You can automate most of 510(k) submission tracking, but not the part most people expect. FDA's own CDRH Customer Collaboration Portal already tracks submission status for free, in near real time [1]. It has no public API, so you cannot pull that status into your own system automatically. What you automate instead is everything around it: the review clock, response deadlines, task ownership, and handoffs between your team and your consultants.

Three things make the difference. Set your portal access up correctly before you file, so the right people can see status at all. Track the deadlines FDA does not show you, especially the 180-day Additional Information response window [2]. And run one milestone model across every submission, so a portfolio of devices does not become a portfolio of spreadsheets.

What FDA tracks for you, and what it will not

FDA built the CDRH Customer Collaboration Portal to meet its MDUFA IV and V commitments, launching progress tracking for 510(k) submissions in 2021 and adding online submission in 2022 [1, 3]. Anyone can register an account [1].

The portal covers more submission types than most teams realize. Progress tracking works for Pre-Submissions, all three 510(k) types (traditional, special, and abbreviated), De Novo classification requests, PMA applications, PMA Panel-Track supplements, IDEs, and Small Business Requests [1].

The dashboard shows near real-time status. It tells you which review stage your submission sits in. FDA also emails your official correspondent separately with official actions and requests [1].

Here is the limit that shapes every automation decision that follows. The portal has no public API. It runs on a Pega platform behind Okta single sign-on, and FDA publishes no integration endpoint. You cannot connect it to your own project tracker, and you should not try to scrape it.

So "automating 510(k) submission tracking" means automating your side of the process. FDA's side stays a manual login.

Set up access before you file, or you will be tracking blind

This step costs nothing and blocks everything if you skip it.

Only the official correspondent or designated delegates can view a submission's status. FDA secures each submission's progress information so nobody else can see it [1].

That matters most for manufacturers outside the US. If you engage a consultant, a US Agent, or a regulatory partner, and that person is listed as official correspondent, they see your submission status and you do not. You will be waiting for their email updates rather than looking at the dashboard yourself.

The fix is simple and has to happen early:

  • Decide who the official correspondent is before the submission goes out, not after.
  • Add designated delegates so more than one person on your side can see status.
  • Confirm the delegate assignment actually worked in the portal, rather than assuming it did.
  • Keep the list current when people change roles or leave the company.

Note that the US Agent role and the official correspondent role are separate. One is a regulatory requirement for distribution. The other controls who can see your submission status. Assigning one does not assign the other.

The same visibility problem shows up inside your own workspace. Complizen's Collaboration module is built for exactly this: invite a consultant into the work without exposing your entire submission history to them.

Track milestones across multiple submissions and product lines

One submission fits in your head. Four submissions across two product lines do not. This is where a defined milestone model stops being administrative overhead and starts preventing missed deadlines.

Use the same milestone set for every submission, regardless of device or product line. That consistency is what makes a portfolio view possible. If you are starting from nothing, Complizen's Submission Builder generates a submission plan from your device profile, which gives you a scoped set of milestones to track against rather than a blank sheet.

Milestone Trigger Clock that starts Typical owner
Submission sent Upload to CDRH Portal Technical screening, about 15 days Regulatory lead
Acknowledgement received FDA confirms receipt — Regulatory lead
Technical screening passed FDA accepts the file MDUFA review clock begins Regulatory lead
Substantive Interaction FDA's first substantive contact, target 60 calendar days [2] Interactive Review or AI hold Regulatory lead
AI Request issued FDA deficiency letter 180 calendar days, no extensions [2] Cross-functional
AI response filed Complete response submitted Review clock resumes Regulatory lead
Decision Clearance, NSE, or withdrawal Post-market obligations begin Regulatory + commercial

Track two clocks per submission, not one. FDA's MDUFA V goal is a decision within 90 FDA days for 95% of submissions [2]. FDA days pause whenever FDA waits on you. Calendar days never pause. A submission sitting at 45 FDA days may be at 120 calendar days if it spent time on an AI hold. Your launch plan runs on calendar days; FDA's performance goal runs on FDA days. Recording only one number hides the gap between them.

Across product lines, add two fields the milestone model does not carry. Record which product family the submission belongs to, and which predicate it relies on. When a predicate gets a recall or a safety signal, you want to know immediately which submissions in flight are exposed, without rereading every file. Complizen's Knowledge module indexes FDA clearances, recalls, and adverse event reports directly, which is what makes that check a lookup rather than a research project.

Build a progress report workflow

A progress report answers three questions: where is each submission, who owns the next action, and what is due next. Everything else is commentary.

This is the step-by-step workflow.

  1. Set a fixed reporting cadence. Weekly works for most teams. Fortnightly works if nothing is on an AI hold. Never report only when someone asks, because that means no one is watching between requests.
  1. Check the CDRH Portal for each active submission. This is the manual step. One person, one session, all submissions, same day each week.
  1. Record the status against your milestone model, using the same milestone names every time. Free-text status notes are what make portfolio reporting impossible later.
  1. Update both clocks. Elapsed FDA days and elapsed calendar days. Compute days remaining on any active AI response window.
  1. Confirm the owner of the next action for each submission. Every submission has exactly one named owner at any moment. Not a team, not a department.
  1. Set or confirm the due date for that next action. Where FDA sets the deadline, use FDA's date. Where you set it internally, make it earlier than FDA's.
  1. Generate the report from those fields, not from memory. Status, owner, next action, due date, days remaining.
  1. Flag exceptions rather than listing everything. Anything with fewer than 30 days remaining, anything that has not moved since the last report, and anything without a named owner.

Automate steps 4 through 8, not steps 2 and 3. The clock math, the deadline alerts, the exception flags, and the report generation are all rules-based and worth automating. The portal check and the status entry stay human, because FDA gives you no other option.

Troubleshoot the three failures that break tracking

Most tracking systems fail the same three ways. Each has a specific structural cause.

Missed handoffs

The symptom: an AI request arrives, and nothing happens for two weeks while people work out who owns the response.

The cause is that AI responses are cross-functional by nature. A deficiency about biocompatibility belongs to testing. One about labeling belongs to regulatory. One about software belongs to engineering. Nobody owns "the AI response" as a whole, so it sits.

The fix: assign a single response owner the day the AI request arrives, before you know what is in it. That owner may delegate individual deficiencies, but they own the deadline. Our guide to responding to FDA Additional Information requests covers the response itself, and responding to an FDA AI letter is one of the workflows Complizen's Superagent is built to run. Where handoffs break most often is context loss, so being able to pass a live thread to a colleague with its history attached matters more than the assignment itself. The tracking point is simply that the 180-day clock runs whether or not someone has claimed it.

Duplicate tasks

The symptom: the same testing gap appears as three open items owned by three people, and closing one does not close the others.

This happens when tracking lives in more than one place. Regulatory keeps a spreadsheet, engineering keeps tickets, and the consultant keeps their own list. Each is correct, none is complete, and reconciling them costs more than maintaining one.

The fix: one system holds submission status. Other systems may hold execution detail, but they reference the submission record rather than duplicating it. If you cannot consolidate, at least designate which system is authoritative for status, and make that explicit to everyone on the project. Keeping the submission itself and the coordination around it in one place is the point of Complizen's Collaboration workspace, rather than reconciling three partial views of the same submission.

Stalled review cycles

The symptom: a submission has not changed status in weeks, and nobody can say whether that is normal.

Some silence is normal. Substantive review takes time, and FDA's target for the Substantive Interaction is 60 calendar days from receipt [2]. Silence becomes a problem only when measured against an expectation.

The fix: set an expected duration for every milestone, and flag anything that exceeds it. A submission at day 75 with no Substantive Interaction is worth a query. A submission at day 30 is not. Without the expected duration, every silence looks identical and you either chase too early or notice too late.

Common mistakes

Trying to automate the portal itself. There is no API, and the login is federated through Okta. Build your automation around the portal, not into it.

Letting the consultant be the only person who can see status. Add designated delegates on your side before filing, not after you notice you are blind.

Tracking calendar days only. You will misjudge where FDA actually is in its review, because FDA days pause and calendar days do not.

Treating the 180-day AI window as a soft deadline. FDA grants the full 180 days automatically and does not extend beyond it [2]. Miss it and the submission is withdrawn and deleted from FDA's system.

Running a different milestone model per submission. It feels flexible on submission one and makes portfolio reporting impossible by submission four.

Frequently asked questions

How do you automate 510(k) submission tracking?

You automate the parts you control: review clock calculations, deadline alerts, task ownership, and report generation. FDA's CDRH Portal shows submission status but offers no public API, so retrieving status from FDA stays a manual check. The practical approach is a scheduled manual portal check feeding an automated tracking and reporting layer on your side.

Does FDA have an API for 510(k) submission status?

No. The CDRH Customer Collaboration Portal provides near real-time status through a secure web dashboard, authenticated through Okta single sign-on. FDA publishes no integration endpoint for it, so submission status cannot be pulled into an external system automatically.

Who can see 510(k) submission status in the CDRH Portal?

Only the official correspondent for that submission and any designated delegates. FDA restricts progress information specifically so that nobody else can view it. If your consultant or US Agent is the official correspondent and you have not been added as a delegate, you cannot see your own submission's status.

What submission types can you track in the CDRH Portal?

Pre-Submissions, traditional, special, and abbreviated 510(k)s, De Novo classification requests, PMA applications, PMA Panel-Track supplements, IDEs, and Small Business Requests.

How long do you have to respond to an FDA Additional Information request?

180 calendar days from the date of the AI request. FDA grants this automatically, so you do not need to request an extension, and FDA does not extend beyond it. If FDA does not receive a complete response addressing every deficiency within 180 days, the submission is considered withdrawn.

What is the difference between FDA days and calendar days?

FDA days count only the time FDA spends actively reviewing. The clock pauses whenever FDA is waiting on you, most commonly during an AI hold. Calendar days never pause. FDA's MDUFA performance goals are measured in FDA days, while your launch timeline runs on calendar days, so a submission can be well within FDA's goal and still be months behind your internal plan.

How should you track multiple 510(k) submissions at once?

Use one milestone model across every submission, regardless of device or product line, and record status against the same milestone names each time. Add fields for product family and predicate device so you can identify exposure quickly when a predicate has a safety issue. Consistency is what makes a portfolio view possible.

What should a 510(k) progress report contain?

Current milestone, elapsed FDA days, elapsed calendar days, the named owner of the next action, the due date for that action, and days remaining on any active FDA deadline. Report exceptions rather than listing every submission in full.

How often should you check submission status?

A fixed weekly cadence works for most teams. Anything on an active AI hold deserves closer attention, since the 180-day window runs on calendar days regardless of internal progress.

Can you track a 510(k) submission if you did not file it yourself?

Only if you are named as the official correspondent or added as a designated delegate. This is worth resolving before filing, because changing it afterwards requires going through whoever currently holds the access.

Key takeaways

FDA's tracking is free, and you probably already qualify for it. The CDRH Portal covers Pre-Subs through PMA supplements, with near real-time status [1].

There is no API, so build around the portal rather than into it. Automate the clock math, alerts, ownership, and reporting on your side.

Access is the step that blocks everything else. Only the official correspondent and designated delegates can see status. Decide this before you file.

The 180-day AI response window is the hardest deadline in the process. It is granted automatically, it does not extend, and missing it withdraws your submission [2].

One milestone model across every submission is what makes a portfolio trackable. Different models per device work until you have four in flight.

Complizen helps international medical device manufacturers reach FDA 510(k) clearance, combining a software platform for in-house regulatory teams with full-service consultancy for teams without in-house FDA expertise.

If you are setting up tracking for your first submission, the foundation matters more than the tooling: the right milestone model, the right access, and a realistic view of your own gaps. Complizen's free Gap Assessment maps your device against FDA's requirements in writing, including a realistic timeline you can build your tracking around. Request your Gap Assessment →

References

  1. FDA — Send and Track Medical Device Premarket Submissions Online: CDRH Portal. https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal
  2. FDA — FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals (guidance, including the 180-day AI response policy). https://www.fda.gov/media/73507/download
  3. FDA — 510(k) Submission Process (review stages, RTA Hold, Substantive Interaction, AI Requests). https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process
  4. FDA — Premarket Notification 510(k) overview. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k