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12 Common Mistakes to Avoid in a 510(k) Submission

Date: 1/18/2024

common mistakes 510(k)

The FDA 510(k) submission reviews new medical devices in two main steps:

1. Acceptance Review (15 days):

  • They check if the application is complete and ready for deeper review.

  • If it's not, they put it on hold and ask for fixes (this happens to about 30% of applications).

2. Substantive Review (up to 60 days):

  • They dig into the details to decide if the device is safe and effective.

  • They often ask for more information (this happens to about 63% of applications).

  • They might say the device isn't similar enough to existing ones to be approved (this happens to about 13% of applications).

Common reasons the FDA asks for more information:

  • Not enough details about the device

  • Information in the application doesn't match up

  • Unclear or problematic descriptions of what the device is supposed to do

  • Not following current guidelines or standards for similar devices

  • Missing results from required tests of how well the device works

  • Missing results from required studies of how the device works in real-world medical settings

Starting your FDA 510(k) expedition? Be mindful of these potential challenges to ensure a smoother process:

1. RTA Letter: Start Strong

  • Mistake: Incomplete initial stage applications.

  • Avoid: Review the acceptance checklist in the "Refuse to Accept Policy for 510(k)s" guidance document.

  • Tip: Informally address Preliminary Questions and focus on Organizational Elements.

2. Device Description: Details Matter

  • Mistake: Inadequate device descriptions.

  • Avoid: Include comprehensive details, technical specs, pictures, and dimensions for all models and accessories.

  • Beware: Missing details may lead to confusion and additional queries.

3. Consistency is Key

  • Mistake: Inconsistencies throughout the submission.

  • Avoid: Align all sections with actual changes; review thoroughly.

  • Warning: Inconsistencies cause delays; extra eyes can prevent mistakes.

4. Intended for Use Alignment

  • Mistake: Different intended use than the predicate device.

  • Avoid: Ensure alignment with the predicate's intended use.

  • Note: Differences may impact safety and efficacy; clarity is crucial.

5. Testing Wisdom

  • Mistake: Inadequate or missing testing information.

  • Avoid: Understand required testing; follow FDA guidance.

  • Reminder: Biocompatibility, software validation, and usability testing may be necessary.

6. Follow Guidance Documents

  • Mistake: Neglecting guidance documents and recognized standards.

  • Avoid: Comply with the latest standards; refer to FDA guidance.

  • Caution: Changes in standards may lead to safety and efficacy questions.

7. NSE Determination Awareness

  • Mistake: Inadequate response during substantive review.

  • Avoid: Collaborate with FDA on requested data; seek clarity.

  • Reminder: Failure to respond may lead to a Not Substantially Equivalent (NSE) determination.

8. Submission Logistics

  • Mistake: Incorrect submission address.

  • Avoid: Double-check the FDA website for the correct address.

  • Tip: Simple, but crucial; avoid unnecessary delays.

9. eCopy Essentials

  • Mistake: Ignoring eCopy requirements.

  • Avoid: Follow eCopy technical standards; refer to FDA guidelines.

  • Important: Adherence prevents eCopy hold; ensure compliance.

10. Timely Responses

  • Mistake: Mishandling information submission after a hold letter.

  • Avoid: Refer to the FDA email or guidance for the correct response location.

  • Note: Ensure timely and accurate responses.

11. 510(k) Type Clarification

  • Mistake: Misclassifying as Traditional or Special 510(k).

  • Avoid: Thoroughly research similar changes; use a risk-based approach.

  • Advice: Enlist help if uncertain; take a conservative approach.

12. Device Nature Challenges

  • Mistake: Overlooking the unique device nature.

  • Avoid: Consider FDA guidance for novel technologies; seek pre-submission meetings.

  • Key: New tech areas may need early FDA engagement.

Conclusion: Proactive Planning Wins

  • Reminder: RTA letters and delays are avoidable with careful planning.

  • Tip: Engage experienced consultants, stay updated on regulations, and follow guidance documents.

  • Success: Navigate the 510(k) process smoothly with a well-prepared and informed approach.

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