FDA 510(k) RTA Check
Refuse to Accept Validation
Pre-check your 510(k) submission against FDA's Refuse to Accept (RTA) criteria before filing. Identify missing documents, administrative gaps, and compliance issues that could delay your submission or result in RTA holds.
What is RTA (Refuse to Accept)?
RTA is FDA's administrative review that occurs before substantive review. If your submission fails RTA criteria, FDA will refuse to accept it and you must fix deficiencies before resubmission—causing delays and additional fees.
Administrative Review
FDA performs RTA review within 15 days of submission. Missing required documents, incomplete forms, or administrative errors result in RTA holds and delay your timeline.
RTA Checklist Criteria
FDA uses specific RTA checklists (based on submission type) to verify required documents, form completeness, eSTAR compliance, and administrative completeness.
Common RTA Issues
Missing cover letter, incomplete FDA forms (3514, 3881), missing Truthful & Accuracy Statement, incomplete device description, missing predicate information, or eSTAR formatting errors.
How AI RTA Check Works
Our RTA validation analyzes your project data against FDA RTA checklist criteria to identify potential issues before submission.
Project Data Analysis
Analyzes your project data including uploaded documents, completed forms, device information, classification results, and submission sections.
RTA Checklist Application
Applies FDA RTA checklist criteria based on your submission type (Traditional, Special, or Abbreviated 510(k)) and device characteristics (software, sterile, electrical, etc.).
Document Presence Verification
Verifies presence of all required documents: cover letter, FDA forms (3514, 3881), Truthful & Accuracy Statement, device description, predicate information, labeling, IFU, and testing reports.
Form Completeness Check
Validates FDA forms for completeness: FDA Form 3514 (device listing), FDA Form 3881 (Indications for Use), and ensures all required fields are populated correctly.
Conditional Requirements Check
Checks conditional requirements based on device characteristics: software documentation (if has software), cybersecurity package (if connected), biocompatibility data (if patient contact), sterilization validation (if sterile).
Deficiency Report Generation
Generates comprehensive report identifying missing documents, incomplete sections, form errors, and administrative gaps with specific remediation guidance for each issue.
Why Use AI RTA Check?
Prevent costly RTA holds and submission delays by identifying issues before filing. Complete RTA validation in 5-10 minutes instead of manual review.
5-10 Minutes, Not Hours
Complete RTA validation with deficiency identification and remediation guidance in 5-10 minutes instead of hours of manual checklist review.
Prevent RTA Holds
Identify and fix administrative gaps before submission. Avoid costly RTA holds that delay your timeline and require resubmission with additional fees.
Complete RTA Coverage
Validates all RTA criteria including required documents, form completeness, conditional requirements, eSTAR compliance, and administrative completeness.
Deficiency Identification
Identifies missing documents, incomplete sections, form errors, and administrative gaps with specific guidance on how to remediate each issue.
Conditional Logic
Applies conditional requirements based on device characteristics. Only checks software docs if device has software, cybersecurity if connected, etc.
Submission Readiness Score
Provides overall submission readiness score with pass/fail status for each RTA criterion. Clear indication of readiness before filing.
Complete RTA Validation Package
Get comprehensive RTA validation covering all FDA acceptance criteria and administrative requirements.
Required Documents Check
Verifies presence of all required documents: cover letter, FDA forms, Truthful & Accuracy Statement, device description, predicate information, labeling, and IFU.
Form Completeness Validation
Validates FDA Form 3514 (device listing) and FDA Form 3881 (Indications for Use) for completeness and correct field population.
Conditional Requirements
Checks conditional requirements based on device: software documentation, cybersecurity package, biocompatibility data, sterilization validation, electrical safety, etc.
eSTAR Compliance
Validates eSTAR template compliance, proper section formatting, required section presence, and electronic submission readiness.
Deficiency Report
Generates detailed deficiency report with pass/fail status for each criterion, missing items list, and specific remediation guidance.
Readiness Score
Provides overall submission readiness score (percentage) with clear pass/fail indication. Track progress as you address deficiencies.
Frequently Asked Questions
Common questions about RTA check and FDA acceptance criteria.
What is FDA RTA (Refuse to Accept)?
RTA is FDA's administrative review performed within 15 days of 510(k) submission. FDA checks for required documents, form completeness, and administrative completeness. If criteria aren't met, FDA issues an RTA hold and refuses to accept the submission until deficiencies are fixed. This causes delays and may require resubmission fees.
What are common RTA deficiencies?
Common RTA issues include: missing cover letter, incomplete FDA Form 3514 or 3881, missing Truthful & Accuracy Statement, incomplete device description, missing predicate device information, missing labeling or IFU, incomplete conditional requirements (software docs, cybersecurity, biocompatibility), and eSTAR formatting errors.
How does AI RTA check work?
AI RTA check analyzes your project data (uploaded documents, completed forms, device information) against FDA RTA checklist criteria. The system verifies document presence, form completeness, conditional requirements based on device characteristics, and eSTAR compliance. Results include pass/fail status for each criterion with deficiency identification and remediation guidance.
Does RTA check validate content quality?
No. RTA check validates administrative completeness (document presence, form completion, required sections) but does not assess scientific or technical content quality. Content quality is evaluated during FDA's substantive review after RTA acceptance. RTA focuses on "do you have the required documents" not "are the documents good enough."
How long does RTA check take?
AI-powered RTA check typically completes in 5-10 minutes. The system analyzes all project data, applies RTA checklist criteria, verifies document presence and form completeness, and generates comprehensive deficiency report. Traditional manual RTA review can take hours.
Can I run RTA check multiple times?
Yes. Run RTA check as you build your submission to identify gaps early. Re-run after addressing deficiencies to track progress and verify readiness before final submission. The readiness score helps you track improvement over time.