PMA Post-Approval Compliance & Supplements: Staying FDA-Ready

Post-Approval Requirements & PMA Supplements

Achieving PMA approval is only the start. FDA requires annual reports, adverse event monitoring, post-approval studies, and supplements for changes. Learn how to manage reporting, MDRs, and PMA supplements effectively to maintain approval and ensure compliance.

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Congratulations, you have a PMA approval! Now what?

Achieving PMA approval is a major milestone, but maintaining that approval and managing your device’s lifecycle is an ongoing responsibility. Unlike 510(k)-cleared devices, PMA-approved devices are subject to a number of post-approval requirements by FDA. These ensure that the device continues to be safe and effective in real-world use and that any changes or issues are properly managed. Non-compliance with post-approval obligations can result in serious consequences (including withdrawal of approval). Additionally, as you iterate and improve your device or expand its uses, you will need to file PMA supplements to get FDA sign-off on those modifications. Let’s break down the key post-approval responsibilities and the types of PMA supplement pathways for changes.

Post-Approval (Annual) Report

FDA regulations require that as a condition of PMA approval, the applicant must submit annual reports on the device’s status. These are sometimes called postapproval reports or periodic reports. Key points:

Summary of Unpublished and Published Data A bibliography and summary of any new data (clinical or nonclinical) that your company or others have obtained on the device since approval. For example, any new in-house testing, any new studies, or relevant scientific literature. If FDA wants copies of particular reports, they will ask.

Changes made under 21 CFR 814.39 The report should list any changes to the device or manufacturing that were made in the last year and how they were reported to FDA. For instance, minor changes that were not required to have a supplement but are reported in annual report (per 814.39(b)), or if supplements were approved during the year, reference those. Essentially, it’s an accounting of device modifications.

Adverse Safety Information Often, the annual report should summarize any adverse outcomes or complaints and how they were handled (though the primary mechanism for serious issues is MDR reporting, see below).

Status of ongoing post-approval studies If FDA required you to do a PAS (Post-Approval Study), provide an update on its progress and any interim results.

Production or distribution data (if required) Sometimes FDA asks for number of devices sold or implanted, to help contextualize adverse event rates.

The annual report is a way for FDA to keep an eye on the device. Continued approval is contingent on submitting these reports. Missing a report or submitting a poor report could lead to compliance actions. Therefore, set up a system to gather necessary info throughout the year. Many companies tie this into their quality management system, ensuring complaints, CAPAs, etc., can be summarized readily.

Medical Device Reporting (MDR) and Other Postmarket Surveillance

Like all medical devices, PMA devices are subject to FDA’s Medical Device Reporting regulation (21 CFR 803). This means you must:

Report certain adverse events to FDA within required timeframes: specifically, any incident in which your device may have caused or contributed to a death or serious injury, and any malfunction that would likely cause death or serious injury if it recurred. These are typically 30-day reports (or 5-day if urgent). You must also maintain records of all complaints and adverse events. In annual reports, you might provide a summary of these (e.g., “In the reporting period, 5 MDRs were filed for the device for events including X, Y...”).
Submit device recall or correction reports if you undertake any field corrections (21 CFR 806). For example, if you issued a safety notice or recall, FDA should be informed (this might be outside the PMA context but integrated with postmarket requirements).

Additionally, FDA can impose 522 Postmarket Surveillance Studies as a condition for certain devices (particularly if device failure could be serious, or it’s used in pediatrics, etc.). These are separate from PAS studies in a PMA order (though in practice, a PAS can fulfill a 522 order). If you get a Section 522 order, you must submit a plan and regular reports on that surveillance.

Example: The transcatheter heart valve PMA approvals included a requirement to conduct a 10-year post-approval study on patients to monitor long-term performance. The manufacturer must submit annual reports on that study progress. Similarly, the artificial pancreas device had a mandated postmarket study with reports. Not doing these studies or not reporting can risk your PMA.

Device Tracking and Other Special Requirements

Some devices are subject to device tracking (like long-term implants – think pacemakers) where you must keep track of patients in case of recall. If FDA required tracking as a condition of approval, you need to implement that (under Section 519(e)). Also, if your device approval had restrictions (e.g., can only be used by certain trained physicians or requires patient registration), you must enforce those and include how you’re doing so in reports.

PMA Supplements – Making Changes After Approval

Devices are seldom static – you may need or want to change the design, materials, labeling, manufacturing process, or indications over time. For a PMA-approved device, any change that affects safety or effectiveness requires FDA approval via a PMA supplement before you implement it. There are several categories of PMA supplements, tailored to the nature and risk of the change:

Panel-Track Supplement This is essentially like a new PMA for a significant change – often a new indication for use or a major change in device design/performance that necessitates clinical data. It’s called “panel-track” because FDA may take it to the advisory panel. Example: expanding your device from adult use to pediatric use would likely be panel-track. The review timeline is extended (could be similar to original PMA timeline). It requires substantial data (often new clinical study).

180-Day PMA Supplement This is the standard supplement for most changes that require FDA approval but are not as major as a panel-track. As the name suggests, FDA aims to process in 180 days. It’s typically for significant changes in components, materials, design, or labeling where the existing clinical data can mostly support safety/effectiveness but some bench or minor clinical data may be needed. For example, adding a new size of heart valve with same design might be a 180-day supplement with bench testing and perhaps an abbreviated clinical confirmation. FDA does a full review but not necessarily panel (unless the change raises new questions).

Real-Time Supplement This is a mechanism for minor changes where you want a quicker, interactive review – for example, a slight modification in software or labeling that does not significantly impact safety/effectiveness. In a real-time supplement, you and FDA agree to have a meeting (in person/teleconference) to jointly review the submission and ideally make a decision in that meeting. It’s meant for changes like small updates to instructions, or minor hardware tweaks, where the data set is limited (perhaps just bench testing). FDA guidance on real-time supplements outlines qualifying criteria. If accepted for real-time, the process is much faster (target around 30 days or so).

“Special” PMA Supplement – Changes Being Effected This is an interesting category allowing certain changes that enhance safety to be implemented immediately (prior to FDA approval). It’s essentially analogous to the “CBE-30” in drug regs. If you have a change that adds or strengthens a safety warning, or improves safety of manufacture (like adding a new warning in labeling, or tightening a spec to improve quality), you can make the change, submit a Special PMA Supplement labeled “Changes Being Effected,” and you don’t have to wait for FDA approval to put that change into effect. There are conditions: you must get acknowledgment from FDA that it qualifies, and the supplement must be properly labeled and include rationale. FDA will later approve it (or discuss if not acceptable). This pathway exists so manufacturers aren’t disincentivized from quickly implementing safety improvements. For instance, if you discover a certain part could be made more reliable, you might not want to wait months – CBE supplement lets you go ahead with improvement.

30-Day Notice / 135-Day Supplement (for Manufacturing Changes) If you change manufacturing processes or facilities, there’s a specific route: a 30-day notice. This is typically for changes in process that affect safety/effectiveness, like a new sterilization method or a new production line. You notify FDA 30 days before implementing. If FDA doesn’t respond in 30 days, you can proceed. If FDA finds the notice inadequate, they’ll tell you that it instead requires a 135-day supplement (which is essentially a 180-day supplement but targeted timeline of 135 days). Many manufacturing changes can be handled via 30-day notices, which is faster. But note: not all qualify; e.g., a new manufacturing site that also entails design changes might not. FDA has guidance listing what changes are appropriate for 30-day notice. If you submit a 30-day notice and FDA says “no, this needs a full supplement,” they’ll convert it to a 135-day supplement using the info already submitted.

Routine Alternate Submissions If a change doesn’t affect safety/effectiveness (minor editorial labeling fix, tiny cosmetic change, etc.), you can document it in the annual report instead of a supplement. The trick is determining that threshold – generally, if truly minor. Example: change in the color of an external accessory that has no effect on performance might just go in annual report.

Managing Supplements Strategically

Changes are inevitable, so have a change control process that involves regulatory early – whenever R&D or manufacturing plans a change, assess if it triggers a PMA supplement and which type. It’s wise to consult FDA via a Pre-Sub for big changes: e.g., if you plan a new clinical study for an expanded indication, confirm with FDA that a panel-track supplement is acceptable and what data they expect. Keep track of all changes implemented under annual report vs. supplements – remember you must list those in the annual report. A common pitfall is making a change without realizing it needed a supplement – that can put you in a compliance bind if FDA finds out (e.g., during an inspection, they see you changed a material without approval). So, internal training on “what changes require FDA approval” is key for your team.

Post-Approval Inspections

After approval, FDA typically does a pre-approval inspection to check manufacturing (often right before approval) and may do periodic postmarket inspections to ensure you’re following QSR, MDR, and post-approval study commitments. Be prepared to show documentation of your annual reports, MDR files, and any changes. FDA will want to see that you didn’t implement unapproved changes. So maintain a PMA dossier with all supplements and FDA correspondence easily accessible.

Examples: After approving the artificial pancreas, FDA required an annual report summarizing any device issues and also a supplement when the company later improved the algorithm. The company submitted a 180-day supplement for an updated software version to further reduce hyperglycemia – FDA reviewed quickly (maybe even via real-time if it was considered minor) and approved the update. The heart valve makers, when they moved production to a new facility, had to file a site-change supplement (180-day) because a new manufacturing site is considered a significant change requiring approval. They also have to submit 30-day notices for changes in processes like a new packaging sterile barrier test method.

In summary, post-approval phase is about vigilance and communication: Vigilance in monitoring your device’s performance in the field and communicating issues via MDRs and annual reports; communication with FDA when you make improvements or modifications via the appropriate supplement pathways. By treating FDA not as a one-time hurdle but as an ongoing regulatory partner, you ensure continued compliance and the ability to adapt your product in the market responsibly.

When ADBC CRO supports you post-approval, we help with preparing high-quality annual reports (so FDA gets the info they need) and strategizing the most efficient way to get changes approved (maybe your change can be a 30-day notice instead of a full supplement – we’ll help determine that). The goal is to keep your device’s regulatory status in good standing while you focus on scaling up and getting the device to all the patients who need it. With diligence on post-approval requirements, you’ll avoid regulatory hiccups and maintain the trust FDA placed in your device through the PMA approval.

Contact us to Navigate PMA Post-Approval Obligations & Supplements

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