Date: 1/18/2024
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.
Provision work professionally while meeting clients' needs.
We will streamline the regulatory processes so that our clients can utilize their time
and money most efficiently.
Experience the best FDA approval directions and solutions!
If you have questions about FDA regulation, Please CONTACT US.
Office 1-909-493-3276
Email:ask@provisionfda.com