Don't Let the U.S. FDA's RTA Policy Derail Your Medical Device Launch

Navigating the U.S. Food and Drug Administration’s (FDA) submission process demands precision, thoroughness, and a clear understanding of regulatory expectations. The FDA’s Refuse-to-Accept (RTA) for 501(k)s policy acts as an initial checkpoint for medical device startups, ensuring that submissions meet the basic requirements before moving on to full review. A rejected submission can delay market entry, increase costs, and disrupt timelines.

The RTA Reality Check: What You Need to Know

The FDA’s RTA policy is a first-line screening process for premarket submissions, including 510(k) notifications, which are required to prove that a device is substantially equivalent to an already approved product. The FDA ensures all necessary components are included before conducting an in-depth review.

Why It Matters

• Encourages thorough and high-quality submissions

• Reduces back-and-forth with the FDA

• Helps medical devices reach the market faster

As of October 2023, the FDA has tightened RTA requirements, particularly in cybersecurity. Companies must now provide robust security documentation, including a Software Bill of Materials (SBOM) and post-market vulnerability management plans.

Eligibility Criteria for 510(k) Clearance

To be eligible for 510(k) clearance, a medical device must meet specific criteria, summarized below.

It is important to note that this list is not exhaustive. Other factors may apply depending on the regulatory environment and the specific device. Many medical device companies collaborate with regulatory consultants to navigate these complexities and ensure their submissions meet all requirements.

Device Risk Level

The FDA categorizes medical devices into three risk levels, each with different regulatory requirements:

• Low-risk devices: Generally exempt from premarket submission, including most Class I and select Class II devices.

• Medium-risk devices (510(k)): Mostly Class II devices, with some Class I devices requiring premarket notification.

• High-risk devices (Premarket Approval - PMA): Class III devices that sustain or support life, are implanted, or present a potentially unreasonable risk of illness or injury.

Device Type

Certain devices are not eligible for 510(k) clearance, including:

• Components of another device

• Custom devices

• Devices intended for investigational use

Device History

A device is not eligible if it:

• Has a history of being banned, withdrawn, or restricted by the FDA

• Was previously rejected for 510(k) clearance or premarket approval

Device Characteristics

The device must:

• Not pose an unreasonable risk to public health or safety

• Be manufactured in accordance with 21 CFR 820 Quality System Regulation (QSR)

• Meet applicable performance standards set by the FDA or international organizations

Substantial Equivalence

To qualify for 510(k) clearance, a device must be substantially equivalent to a legally marketed medical device (known as a predicate device) that has already been FDA-cleared.

FDA 510(k) Review Process and Timeline

Understanding the timeline of the FDA’s 510(k) review process is critical for planning a smooth submission. Here’s how the process unfolds:

• Day 1: The FDA receives the 510(k) application.

• Within 7 days: The FDA sends an Acknowledgement Letter or a Hold Letter if there are issues with user fees and/or eCopy.

• By Day 15: The FDA conducts an Acceptance Review and informs the applicant if the 510(k) is accepted for Substantive Review or placed on RTA Hold.

• By Day 60: The FDA conducts a Substantive Review and communicates a Substantive Interaction, indicating whether the FDA will proceed with an Interactive Review or request Additional Information.

• By Day 90: The FDA sends the final Medical Device User Fee Amendments (MDUFA) decision on the 510(k).

• By Day 100: If a decision is not reached by Day 100, the FDA provides a Missed MDUFA Decision Communication identifying outstanding review issues.

Top 5 Submission Pitfalls That Could Sink Your Launch

1. Missing or Disorganized Documentation

Startups often underestimate the level of detail required in a submission. The FDA will reject it outright if documentation is incomplete, unclear, or scattered.

What You Need

• Device Description: A precise breakdown of the device’s purpose, features, and specifications

• Substantial Equivalence Justification: Clear comparisons to an existing FDA-cleared device

• Labeling and Instructions for Use: Well-defined usage guidelines, warnings, and contraindications

• Performance Testing Data: Bench testing, biocompatibility reports, and clinical data if applicable

How to Get It Right

• Follow the FDA’s acceptance checklist

• Structure your submission logically

• Conduct a pre-submission audit with a regulatory expert

2. Cybersecurity Compliance Gaps

With the rise of connected medical devices, cybersecurity is now a non-negotiable. Many startups overlook essential security requirements, which results in immediate rejection.

What You Need

• Security Controls: Clear measures to protect patient data and device integrity

• SBOM: A complete inventory of software components, including third-party and open-source elements

• Vulnerability Management Plan: A documented process for identifying and resolving security risks post-market

How to Get It Right

• Build a proactive cybersecurity risk management plan

• Ensure SBOMs are machine-readable and meet FDA standards

• Address all known vulnerabilities before submission

3. Weak Substantial Equivalence Justifications

A 510(k) submission must prove substantial equivalence to a previously cleared device. If this comparison is weak, vague, or unsupported, your submission won’t pass.

What You Need

• Predicate Device Selection: A legally marketed device with similar intended use and technological characteristics

• Comparison Data: Clear, well-documented technical and performance similarities

• Risk Assessment: Explanation of how differences do not pose new safety concerns

How to Get It Right

• Choose a predicate device with a close match in intended use and technology

• Clearly outline similarities and differences, backed by strong data

• Include detailed performance testing to demonstrate safety and effectiveness

4. Lack of a Robust Quality Management System (QMS)

An FDA-compliant QMS ensures consistency in design, manufacturing, and testing. A submission lacking QMS documentation often faces rejection.

What You Need

• Design Controls: Processes ensuring the device meets user needs and intended use

• Corrective and Preventive Actions (CAPA): Systems for identifying and addressing quality issues

• Production and Process Controls: Procedures ensuring device consistency and reliability

How to Get It Right

• Align your QMS with the FDA’s Quality System Regulations (QSR)

• Keep detailed records of design controls, corrective actions, and production processes

• Conduct internal audits to verify compliance before submission

5. Inadequate Post-Market Surveillance (PMS) Planning

Once a device is on the market, manufacturers must monitor its safety and effectiveness. A lack of a PMS plan signals non-compliance to the FDA.

What You Need

• Adverse Event Reporting System: A structured process for identifying and reporting device-related incidents

• Ongoing Risk Assessment: A plan for monitoring product performance and safety trends

• Corrective Actions for Identified Issues: Defined steps for addressing emerging safety concerns

How to Get It Right

• Outline a strategy for tracking and addressing cybersecurity vulnerabilities

• Set up an adverse event reporting system

• Ensure compliance with Medical Device Reporting (MDR) regulations

Smart Strategies for a Seamless FDA Submission

Get FDA Input Early with a Pre-Submission Meeting

The FDA’s Pre-Submission (Q-Sub) program allows companies to get feedback before submitting an application, reducing the risk of rejection.

Why It Works

• Provides clarity on regulatory expectations

• Identifies gaps before submission

• Prevents delays by minimizing rework

Use the FDA’s Acceptance Checklist to Your Advantage

The FDA provides structured checklists to guide submissions. Following these checklists ensures you include everything required for acceptance.

Partner with an Experienced Regulatory Consultant

Working with a consultant who specializes in FDA submissions can help you:

• Identify and fix documentation gaps

• Streamline your submission process

• Avoid common regulatory pitfalls

Conduct Internal Audits Before Submission

An internal audit can catch missing documents, inconsistencies, and cybersecurity weaknesses before they become reasons for rejection.

Plan for a Realistic Timeline

Many startups underestimate how long a successful submission takes. Rushing can lead to errors that result in rejection.

Recommended Timeline

• 3-6 months: Gather data, conduct necessary testing, and compile documentation

• 1-2 months: Perform internal audits and regulatory reviews

• 1 month: Finalize submission and prepare for FDA follow-ups

Your Path to FDA Approval Starts Now

The FDA’s RTA policy can be a roadblock or a roadmap, depending on how well your startup prepares. To improve your chances of being accepted on the first round, providing substantial documentation, ensuring cybersecurity compliance, and engaging in thorough planning are essential. You can bring your medical device to market efficiently and confidently by seeking expert guidance and adhering to best practices.

Want to ensure your FDA submission success? Contact SMEDTEC today to learn how we can guide you through the process.