No Predicate. No Shortcuts. Your Evidence Stands Alone.
PMA leadership for Class III devices — the route where safety and effectiveness must be proven outright, with valid scientific evidence, a clinical program, and a quality system that survives a pre-approval inspection.
An Approval Is a License Built on Your Own Data.
Premarket approval is reserved for Class III — devices that sustain life, prevent serious impairment, or present unreasonable risk if they fail. There is no equivalence argument to make. The statute asks for reasonable assurance of safety and effectiveness, demonstrated by valid scientific evidence, and the review examines everything: the clinical data, the manufacturing, the quality system, the labeling.
That scope is why PMA programs are led, not managed. The clinical strategy, the IDE study behind it, the manufacturing module, and the inspection readiness all have to converge on the same filing date — and every one of them is on the critical path.
Most PMAs rest on a pivotal IDE study — designed years before filing, and impossible to repair afterward.
Four Modules Carry the Application. One Strip of Milestones Judges It.
A PMA is best understood as four evidence programs that must finish together — then survive a review with more moving parts than any other device pathway.
Nonclinical
Bench, biocompatibility, animal, shelf-life — run against recognized standards, documented to GLP where it applies.
Clinical
The pivotal study: endpoints, statistics, and conduct FDA will re-analyze — plus every site’s records behind it.
Manufacturing & Quality
The full quality-system description. Unlike a 510(k), FDA inspects before approving — the factory is part of the file.
Labeling & Risk
Indications, contraindications, and the risk information the clinical data has to support line by line.
A PMA Can Be Lost in a Room You Never Prepared For.
Both of these sit inside the review window. Neither is decided by the strength of your clinical results.
The advisory panelA Public Hearing on Your Science
When the questions are novel, FDA convenes outside experts in a public meeting — with your investors, your competitors, and the press in the room. The panel votes. Briefing books, presentations, and murder boards are the work; the meeting is the exam.
The pre-approval inspectionThe Factory Is Part of the Application
FDA inspects your manufacturing before the approval order signs — and often your clinical sites under BIMO. A module that describes the quality system aspirationally meets an investigator who reads it literally.
Six Disciplines That Carry a PMA.
Senior leadership across every module — because the review will find the one nobody owned.
Program Architecture
The multi-year map: IDE, modules, inspection readiness, and panel risk sequenced so the evidence converges on one filing date instead of three.
Pivotal Study Design
Endpoints and statistics negotiated with FDA before enrollment — through Pre-Subs and, where warranted, the IDE itself — because a pivotal study cannot be patched.
Modular PMA Management
Where it fits, modules filed as they finish so review starts early — and deficiencies surface while you can still afford to fix them.
Inspection Readiness
The pre-approval inspection prepared like the exam it is: quality system, design history, process validation, and the site team rehearsed.
Advisory Panel Preparation
Briefing books, presentations, and murder boards for the public meeting where outside experts debate your data on the record.
Post-Approval Obligations
PMA supplements, annual reports, and any post-approval studies — the approval order is a beginning, and its conditions are enforceable.
Every design change after approval is a regulatory decision — panel-track, 180-day, real-time, or annual-report — with its own evidence bar.
A PMA Is a Living License. Supplements Are How It Ages.
The approval order freezes a design, a process, and a label. The product will not stay frozen — and every change routes through the supplement system: panel-track for new indications, 180-day for significant design or process changes, real-time for minor ones, annual-report for the rest. Classifying the change correctly is a discipline, and misclassifying it is a warning-letter finding.
We build the change-classification procedure with the original submission — along with the annual-report calendar and any post-approval study infrastructure — so the license ages under control rather than under audit. The same discipline underpins post-market surveillance done properly.
Six Failure Modes We Are Brought In to Prevent.
PMA failures are rarely data failures. They are convergence failures.
A pivotal study designed alone
Endpoints FDA never agreed to, discovered at filing — the one deficiency no amount of money can fix retroactively.
Manufacturing module written last
The quality system described aspirationally in month 47 — then inspected literally in month 53.
The panel treated as a formality
A public advisory committee met with a slide deck instead of a rehearsed case — on the record, in front of your investors.
Clinical sites that can’t survive BIMO
FDA’s bioresearch monitoring audits reach the sites — and consent, delegation, and data trails at the weakest one speak for the study.
Deficiency responses that re-argue
A major deficiency letter answered with advocacy instead of analysis — the clock stopped, the review team unconvinced.
Supplements filed to memory
Post-approval changes accumulated informally until a routine inspection reads today’s device against the approval order.
PMA Leadership That Has Seen the Whole Arc.
Our leads have run Class III programs from first Pre-Sub to approval order — and through the supplements that followed.
“A PMA is four programs pretending to be one document. The job is making them converge — on the same date, telling the same story.”
The discipline we bring to Class III programs.
Running at Class III? Make the Four Programs Converge.
Bring senior PMA leadership in while the pivotal study is still on paper — that is when the expensive mistakes are still cheap.
Senior-led. Embedded in your team. No junior hand-offs.