An independent, FDA-recognized 3P510k Review Organization under the U.S. FDA CDRH 510(k) Third Party Review Program.
Check Eligibility

The GTPR review process, stage by stage.

From a sponsor's first approach to FDA's final decision — including the sponsor authorization FDA requires and early FDA interaction where applicable.

  1. Phase AIntake & independenceEligibility, conflict-of-interest, engagement & authorization, receipt.
  2. Phase BPrimary reviewAcceptance, assignment, technical review, deficiencies.
  3. Phase CDeterminationRecommendation and quality review; documentation to FDA.
  4. Phase DFDA final decisionFDA retains final authority for all 510(k) clearance decisions.

The end-to-end review process

From a sponsor's first approach to FDA's final decision. Timelines and outcomes are not guaranteed; each submission is evaluated on its own record.

  1. 01

    Initial eligibility determination

    Evaluation of device type, classification and product code against FDA Third Party program eligibility and GTPR's recognized scope.

  2. 02

    Conflict-of-interest assessment

    Independence is screened and confirmed before any engagement is accepted, consistent with FDA recognition requirements.

  3. 03

    Engagement & Sponsor Authorization

    A written Review Agreement establishes scope, responsibilities and terms. The sponsor also provides the FDA authorization letter required in the 510(k) — the authorization permitting GTPR to forward the submission to FDA and to discuss it with FDA on the sponsor's behalf.

  4. 04

    Submission receipt

    The 510(k) submission and supporting documentation are received under controlled, confidential handling.

  5. 05

    Administrative review / acceptance

    The submission is checked for completeness against applicable intake requirements before substantive review begins.

  6. 06

    Reviewer assignment

    Qualified reviewers are assigned — typically a Lead Reviewer, one or more Technical Reviewers, and Lead QA / quality oversight.

  7. 07

    Primary technical review

    Primary technical and regulatory evaluation across the applicable elements of the submission:

    Early FDA interaction, where applicable. A review may include early interaction with FDA to confirm current standards and guidance relevant to the device type.

    • Intended use
    • Indications for use
    • Predicate selection
    • Substantial equivalence
    • Technological characteristics
    • Performance testing
    • Biocompatibility (where applicable)
    • Sterility (where applicable)
    • Electrical safety / EMC (where applicable)
    • Software / cybersecurity (where applicable)
    • Human factors (where applicable)
    • Clinical data (where applicable)
    • Labeling
    • Standards conformance
  8. 08

    Deficiency / clarification cycle

    Questions and deficiencies are communicated to the sponsor and addressed through the interactive review process.

  9. 09

    Recommendation and quality review

    The review is documented and subject to independent quality review before a determination is finalized.

  10. 10

    Submission of review documentation to FDA

    GTPR forwards its assessment and recommendation, with the review record, to FDA through the Third Party pathway.

  11. 11

    FDA final decision

    FDA conducts its review of the documentation and issues the 510(k) decision. FDA retains final authority for all 510(k) clearance decisions.

Ready to begin with an eligibility determination?

Stage one starts with a scope and product-code check.

Check Device Eligibility