Expert Regulatory Strategy & FDA Compliance That Save Time & Money

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Trusted 510(k) Consultant for Fast, Accurate FDA Submissions

Hiring the right 510k consultant can make the difference between a smooth review and months of costly delays. If you’re preparing a 510(k) submission but aren’t sure where to start, or you’ve been burned by a lack of internal expertise or submission rejections, Isaac is here to help. Isaac Erickson works with medical device companies that need compliant and complete FDA submissions at any stage of the process, especially those navigating eSTAR for the first time.

As a specialized 510k submission consultant, Isaac helps clients avoid common pitfalls like missing documentation, unclear device classification, or poorly formatted applications. Whether you’re under pressure to meet investor timelines or worried about getting stuck with a not substantially equivalent determination (NSE), he’ll help reduce that risk and guide you through the process from start to finish.

What 510k Consultants Do And Why It Matters

The 510(k) pathway is one of the most common routes to FDA clearance for Class II medical devices. But the process isn’t simple. Small mistakes can result in Additional Information Requests (AIQs), delayed clearances, or even outright rejection. A qualified 510k submission consultant ensures that your application is complete, well-organized, and aligned with FDA expectations.

eSTAR Submission Expertise

The FDA now requires all 510(k) and De Novo submissions to use eSTAR (Electronic Submission Template And Resource), a standardized electronic system designed to streamline the process. While it improves review efficiency, eSTAR also requires a specific format and structure. If your team is unfamiliar with it, the risk of errors increases.

Isaac can help you:

  • Determine the correct submission type (Traditional, Special, or Abbreviated 510(k))
  • Determine a proper predicate comparison for a 510(k) submission
  • Organize and format your eSTAR application properly
  • Ensure all required sections are complete and validated
  • Prevent common errors that trigger delays or AIQs

Support Across Device Classes

Class I & Class II (510(k) Submissions)

While most Class I devices are exempt, some still require 510(k) clearance. For Class II, substantial equivalence to a predicate device must be shown. Isaac will help prepare strong, data-backed submissions that include clear labeling, device description, performance testing, and risk documentation.

Class III (PMA Submissions)

For high-risk devices requiring PMA, the eSTAR process allows structured submission of clinical data, post-market plans, and manufacturing details. Isaac will help ensure all documentation is accurate and audit-ready, minimizing the risk of setbacks.

Other IMDS Services

medical device label

Medical Device Labeling

Isaac helps companies close these gaps with a comprehensive, audit-ready review that aligns with FDA, EU MDR, and ISO standards.

UDI barcode

UDI Implementation

Isaac helps companies implement and manage UDI systems that meet FDA 21 CFR Part 830 and align with international standards like EU MDR and EUDAMED.

International Product Regulations

International Product Regulations

Isaac can guide you through registration, documentation, and post-market obligations—so you can enter new markets without delays or costly setbacks.

Isaac Erickson

Work With An Experienced eSTAR 510(k) Submission Consultant

Isaac Erickson has helped medical device companies successfully navigate 510(k), De Novo, and PMA pathways. Isaac’s process is built to reduce friction, improve submission quality, and get your device to market faster. Whether you’re building your first 510(k) or need to recover from a stalled application, Isaac offers the support and strategy you need to get it right the first time.

Get Started Now
or call (651) 353-7806

FREQUENTLY ASKED QUESTIONS

You Have Questions, We Have Answers

What is the purpose of eSTAR, and how does it differ from traditional submissions?

eSTAR is an interactive, standardized template designed to help medical device manufacturers submit regulatory applications electronically. Unlike traditional PDF-based submissions, eSTAR:

  • Uses pre-formatted sections to ensure all required information is included.
  • Features built-in validation checks to reduce deficiencies and prevent missing data.
  • Improves FDA review efficiency, leading to faster processing times compared to manual submissions.

As of October 1, 2023, eSTAR is mandatory for all 510(k) and De Novo submissions, with PMAs also adopting the format.

The eSTAR system currently supports:

  • 510(k) Submissions (Traditional, Special, and Abbreviated) – Mandatory
  • De Novo Requests – Mandatory
  • Premarket Approval (PMA) – Recommended

eSTAR does not apply to Humanitarian Device Exemptions (HDEs) or Biologics License Applications (BLAs).

FDA review times vary by submission type:

  • 510(k) Submissions – Typically 90 days, but may be faster due to fewer deficiencies and improved formatting in eSTAR.
  • De Novo Requests – Can take 120–150 days, depending on device complexity.
  • PMA Submissions – Typically 6–12 months, but eSTAR may help reduce review cycles.

Although eSTAR streamlines the process, FDA may still issue Requests for Additional Information (AIQs) if data is unclear or incomplete.