FDA regulatory consulting
From regulatory strategy to a submission ready for review.
Zaliance supports cardiovascular device manufacturers with regulatory planning, submission preparation, and responses to FDA review questions.
The work begins with the device’s intended use, claims, technological characteristics, and available evidence, then establishes the documentation and activities needed to support the proposed approach.
Pathway & submission strategy
Assess classification, potential predicates, submission options, and evidence needs. Identify unresolved questions and dependencies that affect development and submission readiness.
Deliverables may include: regulatory assessments, predicate comparisons, evidence-gap analyses, and submission plans.
Pre-Submissions & FDA engagement
Develop focused questions and supporting materials for FDA discussion. Present the proposed approach clearly, explain the rationale, and identify the feedback needed to guide development.
Deliverables may include: Pre-Submission packages, meeting materials, and documentation of feedback and follow-up actions.
510(k) preparation & technical writing
Prepare and coordinate submission content, including device descriptions, substantial equivalence comparisons, labeling, and summaries of supporting evidence.
Review consistency across the submission and its underlying technical documentation, including software, risk management, performance, and usability information as applicable.
Deliverables may include: submission sections, eSTAR content, technical summaries, and readiness reviews.
Review questions & additional information
Assess FDA questions, identify the evidence or explanation needed, and coordinate responses with the relevant technical contributors.
Deliverables may include: response plans, written responses, revised submission content, and supporting analyses.
Product changes & continued market access
Assess changes to intended use, design, software, labeling, or supported configurations and document their regulatory implications.
Deliverables may include: change assessments, regulatory rationales, and plans for additional evidence or submissions.
FDA strategy insights
Practical analysis of submission planning, FDA engagement, and product changes.
FDA strategy
ECG-MR’s clearance shows the value and boundaries of a PCCP
A cleared ECG-MR change plan offers a practical example of connecting future model and compatibility updates to the evidence needed before release.
FDA strategy
Plan FDA engagement before you commit to validation
Manufacturers should consider an FDA Pre-Submission early in product development, especially for their first submission. This allows for critical feedback to shape evidence strategy and schedule. Engaging with the FDA helps resolve…
FDA strategy
Predicate strategy begins with the product definition
Align intended use, technological characteristics, and the evidence questions before assembling a comparison.