510(k) Submission and FDA Clearance Services
or call (651) 353-7806
If you’re preparing to bring a medical device to the U.S. market, you need a clear, strategic path to FDA clearance. At IMDS, we specialize in 510(k) submissions and related regulatory strategies that help companies like yours move from product concept to market quickly and confidently. I work with startups, established manufacturers, and global firms that need precise, reliable regulatory support for their Class I, II, or III devices.
What Is a 510(k) and When Is It Required?
The FDA 510(k) submission is the most common regulatory pathway for moderate-risk medical devices. It requires demonstrating that your device is substantially equivalent to an already cleared product, known as a predicate. IMDS helps you determine if 510(k) is the right path and ensures that every submission detail meets FDA standards.
My services include:
- Substantial equivalence strategy and predicate identification.
- 510(k) planning for traditional, special, and abbreviated formats.
- Device classification and testing guidance.
- Regulatory analysis to determine when to submit a 510(k)
Understanding FDA Clearance vs Approval
Many device companies misunderstand the difference between FDA clearance and approval. IMDS helps you communicate your product’s correct regulatory status and avoid costly mistakes in marketing and labeling.
- FDA cleared vs FDA approved: what it means and why it matters.
- Labeling review for marketing claims.
- Strategic positioning based on your regulatory status.
510(k) vs PMA vs De Novo: Which Path Is Right?
Choosing the correct submission type early in development can save time, cost, and regulatory risk. IMDS helps you understand the differences between 510(k), De Novo, and PMA submissions and choose the best route for your specific device.
- Risk-based regulatory pathway determination
- De Novo pathway planning for novel technologies
- PMA submission guidance for Class III devices
510(k) vs PMA vs De Novo: Which Path Is Right?
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.
FDA Submission Support Process
Class III (PMA Submissions)
My 510(k) consultants provide end-to-end support from planning to submission and beyond. We develop structured, complete submissions that meet all FDA formatting and content expectations, reducing the risk of delays or additional information requests.
- Full preparation of FDA 510(k) submissions
- Support for eSTAR and eCopy formatting requirements
- Technical documentation review and gap analysis
- FDA Q-submission and meeting support
How IMDS Accelerates Clearance Timelines
I know what causes delays, and I build submissions designed to avoid them. Our proactive communication, deep FDA experience, and commitment to quality documentation help shorten review cycles and increase clearance success rates.
- Efficient documentation workflows.
- Pre-submission strategy and issue resolution.
- Clear agency communication planning.
Post-submission monitoring and follow-up support.
Contact Us for Submission Guidance
Whether you’re planning your first 510(k) or looking to refine your regulatory strategy, IMDS offers expert consulting tailored to your device and business needs.
Let’s simplify your path to FDA clearance. Contact us today to get started.
Other IMDS Services
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 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
Isaac can guide you through registration, documentation, and post-market obligations—so you can enter new markets without delays or costly setbacks.
FAQ
The 510(k) process requires manufacturers to demonstrate that their device is substantially equivalent to a legally marketed predicate. A complete submission includes device description, performance testing, labeling, and administrative forms. IMDS guides you through the whole process from start to clearance.
FDA review times vary but typically range from 90 to 180 days. Delays often occur due to missing information or inadequate documentation. IMDS helps streamline submissions to reduce review time and avoid setbacks.
Clearance is granted for moderate-risk devices through the 510(k) process. Conversely, approval is required for high-risk devices and is achieved through the PMA pathway. Clearance indicates substantial equivalence; approval requires independent proof of safety and effectiveness.
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.
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.
What types of medical device submissions require eSTAR?
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).
How long does the FDA take to review eSTAR submissions?
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.