FDA Plan, Agency Communication and US Marketing Authorization for an Ophthalmology Medical Device Manufacturer

Context

A manufacturer of medical devices for ophthalmology needed a complete regulatory plan for a US pathway, plus disciplined support during FDA inspection-related communication — with the client remaining responsible for the devices and the formal party of record.

Overview

We prepared a complete plan end-to-end. We conducted direct communications with FDA inspectors as authorised by the client and on the client’s behalf. The client remained responsible for the submission and the associated regulatory obligations.

Approach

1. Frame intended US pathway, documentation scope and inspection-facing readiness with the client
2. Author the complete regulatory plan and supporting materials for the client’s use
3. Support and conduct client-authorised dialogue with FDA inspectors
4. Iterate until the plan and related packages met the engagement’s submission and inspection needs

Our role

• Prepared the complete plan from start to finish
• Conducted direct communications with FDA inspectors on the client’s behalf, as authorised by the client
• Documentation, strategy and communication support; the client remained manufacturer of record

What mattered

• Complete plan authorship for the client’s use
• Client-authorised inspector communication with clear party-of-record boundaries
• Documentation discipline suitable for inspection-facing scrutiny

Result

FDA formally approved the client-submitted plan. The client’s devices subsequently received FDA marketing authorization for the United States under the client’s regulatory pathway. The client remained the manufacturer, submission holder and regulatory party of record.

Notes

• The client remained the manufacturer, submission holder and regulatory party of record
• Published anonymously (T2); naming requires a separate publication checklist
• Outcome described for this engagement only

Related

Regulatory support · Device readiness · MedTech · How we work