Introduction

A 510(k) submission is required to be submitted to the FDA by any party intending to market a Class I, II, or III medical device for human use in the United States, unless the device is exempt under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the exemption limitations outlined in section .9 of the applicable classification regulation are not exceeded. Clearance for marketing is granted only after a device has been found to be substantially equivalent (SE) to a legally marketed predicate device, as determined through a review of the submitted 510(k) documentation.

In this guide, we’ll break down the requirements, exemptions, and procedures for submitting a 510(k), helping manufacturers and Importer navigate this critical regulatory process.

When Is a Premarket Notification Submission Required?

A 510(k) premarket notification must be submitted to the FDA by any person or company intending to introduce a medical device into U.S. commerce—unless the device is exempt. This requirement applies broadly under 21 CFR 807.81 and is a key regulatory checkpoint for those marketing Class I, II, or certain Class III devices.

Below is a breakdown of when a 510(k) submission is required, based on FDA regulation:

1. First-Time Introduction of a New Device

If you're planning to launch a medical device into the U.S. market for the first time, a 510(k) is required at least 90 days prior to commercial distribution. This applies when:

• The device is not substantially equivalent to a device already legally in commercial distribution before May 28, 1976 (known as the preamendments date).
• Or, the device is not substantially equivalent to another device that was reclassified into Class I or II after that date.

2. New Distributor or Manufacturer of an Existing Device

Even if a device has already been cleared by the FDA, a new entity distributing or manufacturing that same device must file a 510(k) if they are required to register their establishment under 21 CFR 807.20.

3. Significant Modifications to a Cleared Device

If you’re modifying a device already on the market, you may still need a new 510(k). This includes:

• Changes that could significantly affect safety or effectiveness—for example, altering the design, material, chemical composition, or manufacturing process.
• Major changes in intended use—such as targeting a different patient population or treating a new condition.

When a 510(k) Is Not Required

Not every device change demands a new submission. Here are two key exceptions:

1. Premarket Approval (PMA) or De Novo Reclassification Pending
   If a PMA or a De Novo petition is already under review, a separate 510(k) is not required.
2. Predetermined Change Control Plan (PCCP)
   If your device was cleared with an FDA-accepted PCCP under section 515C, and your changes fall within its scope, you do not need to file a new 510(k).

When Is a Medical Device Exempt from 510(k) Premarket Notification?

While the 510(k) process is a cornerstone of FDA medical device regulation, not all devices require a 510(k) submission before entering the U.S. market. Under certain conditions, custom devices and private-label distributors may qualify for exemption.

Below is a breakdown of the key scenarios outlined in 21 CFR 807.85, where premarket notification is not required.

Custom Devices: Specially Made, Not Generally Marketed

A custom device is exempt from the 510(k) requirement if it meets the definition under Section 520(b) of the FD&C Act. To qualify, the device must:

1. Be specifically ordered by a licensed professional (e.g., physician, dentist) for an individual patient, based on their unique needs.
2. Be used solely by the prescribing professional and not made generally available to or used by other professionals.

Key Feature: These devices are made on a case-by-case basis, not mass-produced, and are intended for unique clinical situations—not for broad market use.

Distributors & Repackagers: When 510(k) Isn’t Required

A distributor or repackager may also be exempt from filing a 510(k) if:

1. The device they’re placing into distribution was already in commercial use before May 28, 1976 (the FD&C Act preamendments date),
   OR
2. Another company has already submitted a 510(k) for the exact same device, and the distributor or repackager does not alter the labeling or design, aside from placing their own name on the product.

Important Note: If any modifications are made to the device or its labeling (aside from branding), the exemption no longer applies.

What Information Is Required in a 510(k) Submission?

To receive FDA clearance under the 510(k) process, manufacturers must submit a comprehensive premarket notification demonstrating that their device is substantially equivalent to an existing legally marketed device (predicate). According to 21 CFR 807.87, each submission must include specific details.

1. Basic Device Information

• Device Name
  Include both the trade/proprietary name and the common or classification name of the device.
• Establishment Registration Number
  If applicable, provide the FDA registration number of the owner or operator submitting the 510(k).

2. Classification & Regulatory Information

• Device Classification
  Indicate the device class (I, II, or III) under section 513 of the FD&C Act. If not classified, state why and provide justification.
• Performance Standards
  Describe steps taken to comply with section 514—which covers applicable performance standards.

3. Labeling & Marketing Material

• Labeling
  Submit proposed labels, instructions, advertisements, and packaging that clearly describe the device and its intended use. Include photos or engineering drawings if applicable.

4. Device Comparison & Technical Details

• Comparison to Similar Devices
  Detail how your device is similar to or different from other products on the market. Include data on:
  • Materials
  • Design
  • Energy output
  • Operational principles
• Significant Modifications or New Indications
  If your device is modified or intended for a new use, include data showing the impact of those changes on safety and effectiveness.

5. Summary or Statement

• 510(k) Summary or 510(k) Statement
  Submit either a 510(k) summary under §807.92 or a 510(k) statement under §807.93, depending on your preferred approach.

6. Financial Disclosure

• Certification or Disclosure Statement
  Provide documentation required under 21 CFR Part 54, related to financial relationships with investigators (if applicable).

7. Clinical Data (If Used)

• U.S. Clinical Data
  Confirm compliance with FDA regulations on human subjects (Parts 50, 56, and 812). If not compliant, explain why.
• International Clinical Data
  If data is from outside the U.S., show compliance with Good Clinical Practice (GCP) under §812.28. If noncompliant, explain and justify credibility and subject protection.

8. Class III Device Considerations (if claiming SE to a Class III device

• Class III Summary and Certification
  If using a Class III predicate, include a:
  • Summary of known safety/effectiveness issues
  • Citation of supporting information
  • Certification of a thorough information search (§807.94)

9. Final Declarations

• Truthfulness Statement
  Certify that all submitted data is truthful, accurate, and complete.
• Additional Information (if requested)
  Be prepared to submit additional data if FDA finds your original 510(k) insufficient. If not submitted within 30 days, your 510(k) will be considered withdrawn.

510(k) Summary vs. 510(k) Statement

510(k) Summary

• Must include:
  • Submitter’s contact details
  • Device description and intended use
  • Predicate device comparison
  • Nonclinical/clinical data (if applicable)
• Publicly available 30 days after FDA’s substantial equivalence decision.

510(k) Statement

• A certification that all safety/effectiveness data will be made available upon request within 30 days.
• Required if no 510(k) summary is provided.

Class III Certification

If referencing a Class III predicate, the submitter must:

• Conduct a reasonable search for safety/effectiveness issues.
• Provide a summary of known risks associated with the device type.

Confidentiality of 510(k) Submissions

• FDA publicly discloses the existence of a 510(k) once the device is marketed.
• For unmarketed devices, confidentiality can be requested for 90 days (extendable if additional information is needed).
• After FDA’s decision, a 510(k) summary becomes public within 30 days.

FDA’s Review & Decision Process

After reviewing a 510(k), FDA may:

1. Declare the device substantially equivalent (SE) → Can proceed to market.
2. Declare it not substantially equivalent (NSE) → Requires a new submission or reclassification.
3. Request additional information → 30-day response window.
4. Delay decision if financial disclosures are pending.

Substantial Equivalence Criteria

• Same intended use as the predicate.
• Same or different but equally safe technological characteristics.
• No new safety/effectiveness concerns.

Key Takeaway

• 510(k) is required for new/modified devices unless exempt.
• Comparison to a predicate device is critical for substantial equivalence.
• Proper formatting and documentation are mandatory.
• Confidentiality is limited—once marketed, details become public.
• FDA’s decision determines market eligibility—SE allows commercialization.

For manufacturers, understanding these regulations ensures smooth FDA clearance and avoids costly delays. Always consult the latest FDA guidance or a regulatory expert when preparing a submission.

Contact Satori OCS Today

Ready to take the next step in navigating FDA regulatory controls for your medical device? Reach out to Satori OCS for expert guidance and support.

Contact Information:

• Email: satoriocs@gmail.com
• Phone: +91 98290 98077
• Website: www.satorics.com

Let us help you streamline your regulatory submission process and bring your medical device to market with confidence.