Step-by-Step Overview of the FDA PMA Process

Step-by-Step PMA Submission Process

Discover the full FDA PMA journey—from early planning and clinical studies to application submission, in-depth FDA review, advisory panel input, and final approval. Learn key steps, timelines, and obligations for successful device approval.

Overview of the PMA Process

Obtaining a Premarket Approval is a multi-stage journey with defined steps and FDA decision points. Broadly, the PMA review process can be divided into four main phases: (1) Preparation and submission of the PMA application, followed by FDA’s acceptance review (filing decision); (2) In-depth scientific review by FDA experts (substantive review); (3) Advisory committee (panel) review for novel or first-of-a-kind devices, where external experts weigh in; and (4) FDA’s final deliberation and decision, culminating in an approval, approvable-with-conditions, or denial letter. Each of these steps involves specific actions for the sponsor (you, the applicant) and for the FDA. Below is a step-by-step walkthrough of the PMA process, from early planning to the moment you (hopefully) receive an approval order.

Early Planning and Pre-Submission Interactions

Determine Regulatory Path & Device Classification

Before preparing a PMA, confirm that PMA is indeed required (as discussed in Topic 2). This means verifying your device is Class III or no suitable predicate exists. Often, sponsors will engage FDA early via a Q-Submission (Pre-Submission meeting) to get feedback on their planned studies or test protocols. While this pre-submission step is voluntary, it is highly recommended, especially for new innovators. Early FDA interaction helps clarify expectations for the PMA content and can prevent costly mistakes. FDA encourages applicants to reach out early – particularly those new to PMAs or working with novel technologies – to discuss what valid scientific evidence will be needed for approval. You might request a Determination Meeting (to agree on the required evidence) or informal feedback on your test plan. Essentially, Step 1 is about laying the groundwork: confirming the pathway and aligning on evidence requirements before heavy investment in trials.

determine

Conduct Required Studies (IDE Phase)

Most PMA devices need clinical data. Sponsors typically must obtain an Investigational Device Exemption (IDE) to conduct a significant risk device trial in the US. Under an IDE, you run carefully controlled clinical studies (and also complete necessary bench and animal testing) to gather the safety and effectiveness data. This phase can take years for pivotal trials. Throughout, maintain good communication with FDA if questions arise. Data development is the longest part of the PMA process – but it happens before the actual submission. By the time you’re ready to compile the PMA, you should have: robust non-clinical data (e.g. bench tests, biocompatibility, manufacturing info) and clinical results demonstrating your device’s benefits outweigh risks.

conduct

Preparing and Submitting the PMA Application

Compile the PMA Application

A PMA is a comprehensive dossier. It will include administrative elements (forms, cover letters, etc.) and multiple technical sections: device description and intended use, manufacturing and quality system information, preclinical study reports, clinical study reports, proposed labeling, a Summary of Safety and Effectiveness Data (SSED), and more. It’s crucial to follow FDA’s guidance on format (e.g., the suggested PMA shell or template). Organize the application into volumes or eCopies per FDA’s requirements (note: as of Oct 2023, FDA mandates electronic submissions via eSTAR for most PMAs). Perform a quality audit of your PMA before submission to ensure all required content is present – FDA will “Refuse to Accept” or file if something critical is missing. Once confident, you will submit the PMA along with the user fee payment. The submission is often done via FDA’s CDRH ePortal (for eSTAR) or by sending an eCopy disk; ensure you get confirmation of receipt.

compile

FDA Acceptance Review (Day 0-45)

After submission, the FDA conducts an administrative and limited scientific review to decide if the application can be filed. This is essentially a checklist-driven screening: have you included all the items required by regulation (per 21 CFR 814.20)? Are the data presented in an analyzable way? Within 45 days, FDA will notify you if your PMA is “Filed” (accepted for full review) or if it’s refused filing due to deficiencies. If filed, FDA assigns a PMA number and the review clock of 180 days starts. If FDA refuses to file, they will send a letter detailing the deficiencies that prevented filing. Common reasons could be missing sections, poorly organized data, or summaries that obfuscate the results. You then have the option to address these issues and resubmit. Assuming your PMA is accepted (filed), it moves to the substantive review phase. (Tip: using FDA’s “PMA Acceptance Checklist” guidance can greatly help in passing the filing review.)

acceptance

FDA Substantive Review and Advisory Panel

In-Depth Scientific Review (Day 0-180)

Now the real evaluation happens. FDA assembles a team of reviewers: experts in engineering, biocompatibility, statistics, clinical medicine, and other relevant fields, plus compliance officers for manufacturing (Quality System) review. They will scrutinize your data to see if it indeed demonstrates safety and effectiveness. Expect interactive communication during this period. By Day 90 or so, FDA often sends Major Deficiency or Minor Deficiency letters asking for clarifications or additional data needed to complete the review. You should respond promptly with amendments to your PMA. (Note: If you submit a lot of new data as an amendment, FDA can extend the review clock by up to 180 days, so it’s best to submit a thorough PMA initially!). You can also request a Day-100 Meeting with FDA to discuss review status and any concerns. During this step, FDA will also conduct a manufacturing site inspection for Quality System compliance (often required before approval). Meanwhile, FDA’s statistical and medical reviewers evaluate the trial outcomes – are the results convincing? Did you meet your endpoints? Any safety signals? This internal review culminates in an FDA position on whether the PMA warrants approval. For first-of-kind devices, FDA typically seeks input from its Medical Devices Advisory Committee (panel of outside experts).

scientific-review

Advisory Committee Panel (if needed)

If convened, a panel meeting usually occurs around day 120-150 of the process (though scheduling can vary). The panel of independent experts (clinicians, scientists, patient representatives) will review your submission and FDA’s analysis, then discuss in an open public meeting. They address questions like: Do the benefits of this device outweigh the risks? Is the evidence sufficient? Panel meetings are critical for novel technologies – they provide recommendations to FDA but are not decisions. In general, all PMAs for first-of-a-kind devices go to a panel, whereas devices following an established type might skip this. As the sponsor, you present your case at the meeting and answer questions. After deliberation, the panel votes on whether to recommend approval, approvable with conditions, or disapproval. FDA takes this advice into account (though it’s not bound by it). Panel review adds transparency and expert scrutiny, often surfacing any controversial issues about the device in a public forum.

advisory

FDA Decision and Post-Decision Steps

FDA Decision Letter Issued

By law, FDA aims to complete PMA review and issue a decision within 180 days of filing. Practically, some PMAs may take longer if there are multiple rounds of questions. However, once the review is complete (and panel input, if applicable, is considered), FDA will issue one of four outcomes:

decision-letter

For most sponsors, the likely outcomes are either approvable or not-approvable letters if there are issues, since FDA often gives a chance to correct deficiencies before outright denial. Assuming you receive an Approvable or Approval letter, you move to the next step.

Address Conditions and Finalize Approval

If you got an approvable letter, you must now satisfy the conditions (e.g., submit revised labeling, ensure your manufacturing site passes inspection, or agree to postmarket commitments). Once you do, FDA will issue the formal Approval Order. If you got an immediate Approval, there may still be “conditions of approval” like conducting a post-approval study or adhering to certain marketing restrictions. You must comply with these going forward. Also, once approved, you must register and list your device with FDA before commercial distribution. FDA will also include your device in the published PMA database and usually in a quarterly notice in the Federal Register announcing recent approvals.

address

Post-Approval Obligations Begin

Approval is not the end – you now enter the postmarket phase with specific obligations (covered in Topic 10). You must submit annual reports to FDA, track adverse events via Medical Device Reporting, and file supplemental PMAs for any changes to the device. In many cases, FDA requires a Post-Approval Study (PAS) as a condition – for instance, a 2-year follow-up study on patients to monitor long-term safety. Ensure you have resources allocated for these commitments.

post-approval

By following this step-by-step process diligently, sponsors can navigate the PMA with fewer surprises. It’s a complex project, but breaking it into steps – preparation, submission, review, and decision – helps manage tasks and timelines. Early engagement, thorough submission, and responsive communication with FDA are key to moving through each step efficiently. With ADBC CRO’s support, you can confidently shepherd your PMA from concept to approval, one step at a time.

Contact us for a step-by-step guide to the PMA submission process.

0 +

Customer Served

0 +

Product Launched

0 +

Regulatory Submissions