Approval-Ready PMA Strategy | Built for High-Risk Device Pathways
Class III devices require airtight regulatory strategy from the first pre-sub through panel prep and post-approval changes. We build modular PMA submissions, clinical study protocols, IDE packages, and deficiency response playbooks that stand up to FDA scrutiny and keep your timeline predictable.
Why Class III / PMA Programs Stall
Most PMA delays aren't "bad science"—they're strategic gaps: unclear endpoints, incomplete nonclinical packages, misaligned pre-subs, weak statistical plans, and deficiency responses that raise more questions than they answer. We help you build a defensible strategy that connects device design → nonclinical evidence → clinical protocol → modular submission → panel narrative.
- Pre-submission planning: strategic use of pre-subs to align endpoints, controls, and evidentiary standards early.
- Nonclinical completeness: biocompatibility, bench testing, sterilization validation, and shelf life that support clinical go.
- Clinical study design: protocols with clear endpoints, appropriate controls, and statistical power that FDA accepts.
- Modular PMA structure: organized technical sections that reviewers can navigate without circular references or gaps.
Class III & PMA Strategy Programs
Structured programs that get you to approval faster—and defend against deficiencies.
Pre-Submission Strategy & Roadmap
Typical range: $8,000–$25,000
For teams needing a clear PMA pathway before committing to clinical studies or major nonclinical work.
- Pre-sub package: device description, indications, predicate analysis, proposed clinical approach
- Meeting prep, attendance, and post-meeting interpretation + action plan
- Regulatory roadmap: nonclinical, clinical, manufacturing, and submission milestones
Clinical Study Protocol & IDE Support
Typical range: $15,000–$60,000+
For devices requiring pivotal clinical data—with protocols, endpoints, and statistical plans FDA will accept.
- Protocol development: endpoints, inclusion/exclusion, control strategy, follow-up schedules
- IDE package: investigational plan, risk analysis, monitoring plan, informed consent framework
- IRB submission support and protocol amendment management during study execution
Modular PMA Build & Technical Sections
Typical range: $25,000–$100,000+
For teams ready to compile and submit—needing organized technical sections, nonclinical summaries, and labeling integration.
- Device description, indications for use, and comparison to predicates or similar devices
- Nonclinical summary: biocompatibility, bench performance, sterilization, shelf life, software validation
- Manufacturing and quality system summary, labeling review, and clinical data integration
Panel Preparation & Deficiency Response
Typical range: $12,000–$50,000+
For companies facing advisory panel review or major deficiency letters needing strategic response planning.
- Panel narrative development, slide deck coordination, and Q&A preparation
- Deficiency letter interpretation, response strategy, and supplemental data package assembly
- Stakeholder alignment and FDA meeting strategy for complex issues
Who We Help
Implantable & Life-Sustaining Devices
Programs where clinical evidence standards are high and nonclinical packages must support long-term safety claims.
Novel Mechanisms & First-in-Class
Devices without clear predicates needing customized evidentiary strategies and strong pre-sub engagement.
Combination Products
Drug-device or biologic-device combinations requiring coordinated regulatory strategy across CDRH and CDER/CBER.
IDE to PMA Transition
Teams completing pivotal studies needing clean data packages, statistical reports, and clinical summaries for submission.
Deficiency Recovery
Organizations facing major deficiency letters or approvable letters needing strategic response and supplemental evidence.
Post-Approval Supplements
Companies needing PMA supplement strategy for design changes, indication expansions, or manufacturing moves.
How We Run PMA Strategy Engagements
We build modular, defensible submissions that reviewers can navigate—and that hold up under panel scrutiny.
Pre-Sub & Endpoints
We align your regulatory strategy with FDA through strategic pre-subs, defining endpoints and evidentiary standards early.
Nonclinical & Clinical
We guide nonclinical testing and clinical protocol development to ensure your evidence package is complete and cohesive.
Modular PMA Sections
We build organized technical sections, integrate labeling, and create reviewer-friendly summaries that support rapid review.
Panel & Deficiencies
We prepare panel narratives, respond to deficiency letters strategically, and manage post-approval change control.
Class III & PMA Strategy FAQs
When should we schedule our first pre-submission meeting?
Ideally before finalizing your clinical protocol or committing to major nonclinical studies. Pre-subs are most valuable when you have a clear device concept but need FDA input on endpoints, controls, or evidentiary standards.
What's the most common reason for PMA deficiency letters?
Incomplete nonclinical packages (missing biocompatibility endpoints, insufficient bench testing, weak statistical analysis) and clinical protocols with unclear endpoints or inadequate follow-up periods. Both can be avoided with strong pre-sub strategy.
Do we need a clinical study for every Class III device?
Not always. Some Class III devices can leverage literature, real-world evidence, or nonclinical testing if the device is similar to approved devices and the risk profile is well-characterized. Pre-sub meetings clarify evidentiary expectations.
Are these pricing ranges fixed?
No—these are typical working bands. After a triage call we provide a fixed or milestone quote based on device complexity, clinical pathway, nonclinical scope, and whether you need strategy, execution support, or full submission assembly.