FDA 510(k) Consulting Services for Medical Devices

•  Complete 510(k) Documentation Preparation
   
• 🇺🇸 US Agent Representation for Foreign Manufacturers
   
•  FDA Submission Review & Coordination
   
•  FDA Establishment Registration Assistance
   
•  UDI (Unique Device Identification) Compliance Guidance
   
•  FDA Labeling Requirements Support
   
•  FDA Quality System Regulation (QSR) Assistance
   

With increasing scrutiny from the FDA, it's essential to communicate effectively and submit thoroughly prepared documentation. Our consultants not only streamline the process but also help you mitigate regulatory risks, avoid costly delays, and ensure your device meets all FDA expectations for safety and effectiveness.

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• Key Responsibilities of FDA 510(k) Consultants
• FDA 510(k) consultants serve as critical partners for medical device manufacturers, helping them navigate the complexities of regulatory compliance and submission. Their role is to ensure every component of the 510(k) process meets FDA standards—reducing delays and increasing the likelihood of first-round clearance.
• At RAPS, our consultants provide comprehensive support throughout the 510(k) lifecycle, including:

 Regulatory Strategy & Classification

• Determine the device classification, product code, and applicable regulation number
   
• Identify a suitable predicate device in collaboration with the manufacturer
   
• Recommend the correct 510(k) submission type (Traditional, Abbreviated, or Special)
   
• Interpret and apply relevant FDA guidance documents and special controls
   
•  Documentation & Technical File Preparation
• Draft the Indications for Use statement
   
• Prepare the Declaration of Conformity
   
• Identify required biocompatibility, performance, and stability tests
   
• Develop sampling plans and assess risk management documentation
   
• Define sterilization protocols and validate supporting documentation
   
• Review labeling for compliance with FDA regulations
   
• Compile the 510(k) Summary and Predicate Comparison Table
   
• Assess need for clinical data or bench testing
   
• Address device-specific requirements, including software validation, EMC, and electrical safety
   
•  Pre-Submission & FDA Interaction
• Support with Q-Submissions (Pre-Sub) for early FDA feedback
   
• Ensure compliance with FDA’s Refuse to Accept (RTA) policy
   
• Prepare and format the submission as an eCopy for FDA review
   
• Actively communicate with the FDA during the initial, substantive, and interactive review phases
   
• 🇺🇸 Post-Submission Support
• Assist with FDA device listing and establishment registration
   
• Provide US Agent Services for foreign manufacturers
   
• Address any follow-up inquiries until the 510(k) clearance is granted

• Partner with the RAPS Team of FDA 510(k) Consultants
• Choosing RAPS means gaining a strategic advantage through our experienced FDA 510(k) consultants, who have helped secure numerous clearances across global markets. Our proven approach is designed to streamline your regulatory journey, reduce delays, and ensure full compliance with FDA requirements.
• Why Work With RAPS for Your 510(k) Submission?
•  Regulatory Assessment
  We verify whether your medical device falls under FDA oversight and confirm if a 510(k) submission is required.
   
•  Pathway Selection
  We help you identify the most appropriate 510(k) route—Traditional, Abbreviated, or Special—to achieve faster clearance.
   
•  Predicate Device Strategy
  Our experts assist in selecting the right predicate device to demonstrate substantial equivalence effectively.
   
•  Expert Documentation & Review
  Our team prepares and organizes submission documents meticulously, ensuring compliance with all regulatory standards and identifying potential gaps before submission.
   
•  FDA Insight & Compliance Expertise
  With deep knowledge of current FDA regulations and submission trends, we guide you through the process with confidence and clarity.
   
•  Testing & Study Recommendations
  We help you identify necessary performance tests, relevant FDA-recognized consensus standards, and whether clinical or non-clinical studies are required.
   
•  End-to-End Submission Support
  From initial planning through final clearance, we offer personalized guidance and hands-on support at every phase of your 510(k) journey.
   
•  Timely Preparation & Ongoing Communication
  We prioritize timely submission and maintain active communication with the FDA during the initial review, substantial review, and interactive review phases.
   
•  Full Partnership Until Clearance
  At RAPS, we stay with you until your device receives FDA 510(k) clearance—ensuring no step is overlooked.
   

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• Choose the Right FDA 510(k) Consulting Package for Your Needs
• At RAPS, we understand that each manufacturer has unique requirements. That's why we offer flexible FDA 510(k) consulting service packages to meet you where you are—whether you need full regulatory support or a targeted review of your existing documentation.
•  Package 1: Full-Service 510(k) Consulting ("Total Package")
• Ideal for companies seeking end-to-end support—from initial assessment to FDA clearance.
• Services Include:
• Verification of device classification, product code, and regulation number
   
• Assistance in identifying the most appropriate predicate device
   
• Complete preparation and maintenance of the 510(k) file until clearance is obtained
   
• US Agent services for non-U.S. companies
   
• Submission of electronic and hard copies to the FDA
   
• Direct communication with the FDA, including responses to review comments and file resubmissions if needed
   
•  Package 2: 510(k) File Review & Gap Analysis
• For manufacturers who have prepared a 510(k) internally but need expert review to ensure completeness and compliance.
• Services Include:
• Detailed review of your completed 510(k) submission
   
• Delivery of a comprehensive Gap Assessment Report
   
• Recommendations to close any deficiencies before final submission
   
•  Package 3: US Agent + Submission & FDA Liaison
• Designed for international manufacturers who need local representation and submission support.
• Services Include:
• US Agent representation, as required by FDA for non-U.S. entities
   
• Serving as your point of contact with the FDA for all communications
   
• Management of eCopy and hard copy submissions on your behalf
   
• Not sure which package is right for you? Contact RAPS today for a free consultation, and we’ll help you select the best pathway to FDA 510(k) clearance.