FDA Plan, Agency Communication and US Market Clearance 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 and conducted direct communications with FDA inspectors as authorised by the client and on the client’s behalf. We are not the FDA and do not speak as the agency.

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
• Led direct communication with FDA inspectors on the client’s behalf (client-authorised)
• Documentation, strategy and communication support partner — not the manufacturer of record unless a written contract defines that role, and not the FDA

Result

The plan was approved by the FDA. Subsequently, the devices were cleared for the US medical market under the client’s pathway. Clearance was a client-owned regulatory outcome following this programme of plan preparation and authorised agency communication — not an FDA partnership, and not a guarantee of future clearances.

Boundaries

• No partnership with FDA; we do not grant clearance ourselves
• Client remained accountable as manufacturer / party of record for the devices
• Published anonymously (T2); naming requires a separate publication checklist
• Outcome described for this engagement only

Related

Regulatory support · Device readiness · MedTech · How we work