What is a RTA Hold? FDA Refuse to Accept Policy Guide 2025
- Beng Ee Lim
- Jul 4
- 6 min read
An RTA (Refuse to Accept) hold occurs when FDA determines your medical device submission is administratively incomplete and cannot proceed to substantive review. RTA holds affect approximately 60% of 510(k) submissions and require complete resubmission within 180 days to avoid automatic withdrawal.
Quick Answer: RTA holds result from missing required information, inadequate documentation, or failure to follow FDA's acceptance checklists. Unlike substantive review issues, RTA problems are entirely preventable through proper submission preparation and checklist compliance.
Getting RTA'd means your submission timeline resets to zero. This guide covers common RTA triggers, prevention strategies, and recovery procedures.
What Triggers an RTA Hold?
Administrative Completeness Review
FDA conducts RTA review within 15 days of submission receipt. This administrative screening verifies your submission contains all required elements before substantive scientific review begins.
RTA screening covers:
Required forms and administrative information
Complete device description and intended use
Predicate device comparison (for 510(k)s)
Required testing documentation
Proper labeling and regulatory history
Common RTA Triggers
Missing Required Sections The most frequent RTA cause is simply leaving out required checklist items without explanation. FDA reviewers must verify every checklist element is present.
Inadequate Device Description Vague or incomplete device descriptions that don't provide sufficient detail for FDA to understand your device's technology and intended use.
Poor Predicate Analysis For 510(k)s, inadequate substantial equivalence comparison or inappropriate predicate device selection.
Incomplete Testing Information Missing test reports, inadequate test summaries, or failure to address applicable consensus standards.
Cybersecurity Documentation Gaps Since 2023, cyber devices require specific cybersecurity documentation. Missing SBOM, vulnerability management plans, or security risk analysis triggers RTA.
RTA vs. Substantive Review Issues
RTA Hold = Your Fault: Administrative completeness issues are entirely preventable through proper preparation.
Substantive Issues = Negotiable: Scientific disagreements during substantive review can be discussed and resolved with FDA.
The 180-Day Clock: What Happens After RTA
Immediate Actions Required
180-Day Response Deadline: You have exactly 180 days from RTA notification to submit complete response addressing all identified deficiencies.
Complete Resubmission Required: No piecemeal responses allowed. You must address every RTA issue in a single comprehensive response.
Automatic Withdrawal: If you don't respond within 180 days, FDA automatically withdraws your submission on day 181.
RTA Response Strategy
Address Every Issue: Your response must systematically address each item identified in the RTA checklist. Missing any item results in RTA2 (second RTA).
Provide Clear Organization: Use FDA's suggested response format to make reviewer evaluation efficient and complete.
Include Complete Documentation: Don't just reference missing information—provide the actual documents and data FDA needs.
What RTA Means for Timelines
Complete Timeline Reset: RTA response is treated as new submission with fresh review clock starting from zero.
No Review Credit: Time spent in RTA doesn't count toward FDA's review performance goals.
Delayed Market Access: RTA adds minimum 3-6+ months to your regulatory timeline.
RTA Prevention: The Checklist Approach
Use FDA's Official Checklists
Traditional 510(k): Appendix A of FDA's RTA guidance
Abbreviated 510(k): Appendix B of FDA's RTA guidance
Special 510(k): Appendix C of FDA's RTA guidance
De Novo Requests: Acceptance checklist in De Novo guidance
Pre-Submission Quality Control
Internal RTA Review: Have someone not involved in submission preparation conduct checklist review using FDA's exact criteria.
Section-by-Section Verification: Verify each required element is present and adequately documented.
Explanation for Omissions: If any checklist item doesn't apply, provide clear explanation rather than omitting entirely.
Critical Documentation Areas
Administrative Information
Complete contact information and official correspondent designation
Proper submission type identification and cover letter
Required forms (3514, Indications for Use, etc.)
Device Description
Comprehensive technology description with sufficient detail
Clear intended use statement matching predicate (510(k))
Complete device specifications and performance characteristics
Predicate Analysis (510(k))
Appropriate predicate device selection with justification
Point-by-point substantial equivalence comparison
Performance comparison with supporting data
Testing Documentation
Complete test reports addressing applicable standards
Adequate test summaries with conclusions
Biocompatibility, electrical safety, software validation as applicable
Cybersecurity Requirements (Cyber Devices)
Software Bill of Materials (SBOM)
Cybersecurity risk assessment
Vulnerability management procedures
eSTAR's RTA Prevention Advantage
How eSTAR Eliminates Most RTAs
Automated Validation: eSTAR templates identify missing information before submission through real-time validation.
No RTA Review: Properly completed eSTAR submissions bypass traditional RTA screening process entirely.
Technical Screening: eSTAR submissions undergo technical screening instead of RTA review, focusing on submission completeness rather than administrative checklist compliance.
eSTAR Submission Requirements
Complete Template: All required sections must be completed with "eSTAR Complete" status before submission.
Relevant Attachments: All attachments must be relevant to their corresponding questions to pass technical screening.
Accurate Responses: Inaccurate dropdown selections or responses can trigger technical screening hold similar to RTA.
When eSTAR Submissions Face Holds
Technical Screening Hold: 180-day hold for incomplete eSTAR or irrelevant attachments, requiring complete replacement submission.
Virus Scanning Issues: Technical problems with file formats or embedded content can delay processing.
RTA Recovery: Fixing Your Submission
Systematic Response Approach
Analyze Every RTA Item: Create spreadsheet tracking each deficiency with specific location in submission and required action.
Address Root Causes: Don't just add missing information—understand why items were missing and fix underlying preparation process.
Enhance Problem Areas: Use RTA feedback to strengthen weak areas beyond minimum requirements.
Organize Response Clearly: Use FDA's suggested format making it easy for reviewers to verify each issue is resolved.
Common Response Mistakes
Incomplete Resolution: Addressing only some RTA items while missing others guarantees RTA2.
Poor Organization: Difficult-to-follow responses waste reviewer time and increase error risk.
Minimal Compliance: Meeting bare minimum requirements without strengthening overall submission quality.
Late Submission: Cutting response deadline close risks automatic withdrawal if any issues arise.
Response Quality Control
Independent Review: Have fresh eyes review your RTA response using original checklist criteria.
Complete Documentation: Ensure all referenced information is actually included in response package.
Clear Cross-References: Make it easy for FDA to locate information addressing each RTA item.
Your RTA Prevention Strategy
Pre-Submission Phase
Use official FDA checklists as your submission preparation roadmap, not just final verification tool.
Conduct internal RTA review using someone not involved in original submission preparation.
Consider eSTAR submission to eliminate traditional RTA risk through automated validation.
Quality Control Process
Create submission checklist mapping FDA requirements to your specific device and submission type.
Document decision rationale for any areas where standard requirements might not fully apply.
Plan adequate timeline allowing proper preparation without deadline pressure compromising quality.
Team Training
Train submission teams on common RTA triggers and prevention strategies specific to your device types.
Establish review procedures ensuring consistent quality control across all submissions.
Monitor FDA guidance updates affecting RTA criteria and submission requirements.
Bottom Line: RTA Prevention Is Everything
RTA holds are completely preventable administrative failures that reset your regulatory timeline to zero. With 60% of 510(k)s getting RTA'd, prevention isn't optional—it's essential for regulatory success.
The companies that avoid RTA focus on submission quality from the beginning rather than trying to fix problems after FDA identifies them. Use FDA's checklists as preparation tools, not final verification steps.
Your submission timeline and success depend on getting this right the first time.
Ready to prevent RTA delays?
Complizen's AI-powered platform helps identify potential RTA issues before submission and ensures your regulatory applications meet FDA's acceptance requirements.
Frequently Asked Questions
Can I appeal an RTA decision?
No, RTA decisions aren't appealable because they're administrative completeness determinations. However, you can respond within 180 days by addressing all identified deficiencies.
Does RTA affect FDA review performance goals?
RTA submissions don't count toward FDA's review timeline goals, so there's no pressure for quick RTA resolution. Focus on complete, quality responses rather than speed.
Can I request a meeting about my RTA?
FDA generally doesn't hold meetings about RTA issues since they're administrative matters with clear resolution requirements. However, you can request clarification on specific RTA items if unclear.
What happens if I get RTA'd twice?
RTA2 (second RTA) means you still haven't adequately addressed all original issues. You get another 180 days, but repeated RTAs indicate serious submission preparation problems requiring process overhaul.
Does using eSTAR guarantee no RTA?
eSTAR eliminates traditional RTA review, but technical screening can still result in holds for incomplete submissions or irrelevant attachments. Proper eSTAR completion is essential.
