Service
IDE, EFS and marketing submissions
The application, written by the people who will answer the review.
What this covers
We have significant experience taking Class III cardiovascular devices through IDE with FDA, the clinical stage on which a PMA is ultimately built. The IDE is where most first-time sponsors meet the agency for real.
IDE and Early Feasibility Studies
The original IDE application: report of prior investigations, investigational plan, risk analysis, manufacturing information, investigator agreements, labeling, and the informed consent. For an Early Feasibility Study, the justification for starting with a limited nonclinical package and the plan for iterating the device under the approved IDE. FDA decides within 30 days.
After approval: supplements for device and protocol changes, five-day notices, annual progress reports, and the sponsor's reporting duties.
510(k) and De Novo
For Class II devices, the substantial equivalence argument and the eSTAR that carries it, or the De Novo request when no predicate exists. We track the review clock and prepare for the Additional Information request rather than hoping there will not be one.
PMA planning
A PMA is built on the clinical evidence the IDE produces. We plan the PMA from the IDE stage so the pivotal data, the manufacturing section, and the nonclinical modules land in a submission designed around them.
When you need it
When the bench and animal work is done and the next step is a first human study, or when a Class II device is ready for its 510(k) or De Novo. If FDA has already given Pre-Submission feedback, the application starts from those minutes. If it has not, start with the Pre-Submission.
What you receive
- The complete applicationWritten, assembled, and checked against FDA's refuse-to-accept criteria before it goes.
- A readiness reviewThe gaps a reviewer will find, listed and closed before filing.
- Clock managementEvery FDA deadline and every sponsor deadline in one calendar, with owners.
- Post-decision planThe response to approval with conditions, deficiencies, or additional information requests, prepared in advance.
What we need from you
- Bench and animal reportsFinal or draft. We will tell you which ones the submission needs.
- Risk analysis and design historyYour ISO 14971 file and design control records.
- Draft protocol and labelingInvestigational plan, consent, and the device labeling as it will ship.
- Prior FDA feedbackPre-Submission minutes and any earlier correspondence.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.