LK CONSULTING GROUP
FDA Consulting
To export or distribute medical devices in the U.S. market, FDA Establishment Registration and Device Listing are mandatory. All covered establishments—manufacturers, importers, and specification developers alike—must complete and maintain their registration and listing in full compliance with FDA requirements. LK Consulting analyzes the applicable FDA regulations and your product-specific details to keep your Registration & Listing accurate and efficient from day one.
Consulting Service Scope
•U.S. Agent service
•FDA Establishment Registration
•Device Listing registration and maintenance
•Serving as U.S. Agent
•Annual Renewal guidance and management
•Product Code review
•Support with FURLS and FDA account setup
•Advisory on product listing strategy for export
•Review of Private Labeling and Contract Manufacturing structures
•Support with Registration / Listing information changes and updates
•FDA regulatory advisory
•Resolution of FDA-related issues during U.S. import clearance
The LK Consulting Difference
FDA Registration and Device Listing are far more than administrative formalities—they are regulatory tasks that demand a precise understanding of product classification and establishment roles. Errors in registration or listing can trigger import clearance problems down the road and may even draw an FDA warning. With hands-on experience across a wide range of manufacturers and product categories, LK Consulting designs Registration & Listing strategies tailored to your product and business structure—and stays with you for the long term, from initial registration through annual renewals, product additions, and information updates.
The 510(k) is the most common clearance pathway for Class II medical devices entering the U.S. market, requiring a demonstration of Substantial Equivalence to a legally marketed predicate device. Leveraging our proprietary database of the deficiencies the FDA raises most frequently in each product category, we deliver document review and refinement services precisely tailored to your device.
Consulting Service Scope
•Review of 510(k) feasibility and clearance pathway options
•Advisory on Traditional / Special / Abbreviated 510(k) strategy
•Provision of the required 510(k) document checklist
•Support with preparing and submitting eSTAR-based 510(k) submissions
•Predicate device selection and Product Code analysis
•Development of the Indications for Use strategy
•Development of performance testing and validation strategy
•Review and editing of technical documentation, including Labeling and IFU
•Support with responding to FDA Additional Information (AI) requests
•Q-Sub and SIR submissions as part of a deficiency-response strategy
•Serving as FDA Official Correspondent
•Communication with FDA reviewers in U.S. local time
•Support with applying for the small-business 510(k) user fee discount
•Regulatory advisory for post-clearance product changes
The LK Consulting Difference
A 510(k) is not a paperwork exercise—it is the process of building a logically compelling case for substantial equivalence from the FDA reviewer's perspective. Drawing on real clearance experience across a broad range of medical device fields, LK Consulting brings a strategic approach shaped to each product. Proud of our record of the most 510(k) clearances in the shortest time, we build the latest FDA review trends—from predicate selection to testing strategy—into a clearance strategy designed to minimize your costs and shorten your review timeline.
De Novo is the FDA marketing pathway for novel medical devices that lack a predicate with the same intended use or technology. It is more demanding than a 510(k) and, in most cases, calls for clinical evidence. Attuned to the unique characteristics of innovative devices and FDA expectations, LK Consulting provides expert support across the entire De Novo journey—from initial strategy through final authorization.
Consulting Service Scope
•Analysis of the product's De Novo suitability and regulatory pathway
•Development of a classification strategy in the absence of a predicate
•Preparation and submission of a Pre-Submission (Q-Sub) for advance consultation with the FDA
•Support with preparing and submitting eSTAR-based De Novo submissions
•Development of the Indications for Use statement
•Benefit-Risk analysis and review of Risk Management documentation
•Development of non-clinical and clinical study strategy
•Review of performance test protocols and validation data
•Review of all technical documentation, including Labeling and the IFU (Instructions for Use)
•Support with responding to FDA Additional Information (AI) requests
•Regulatory advisory for post-clearance product changes
The LK Consulting Difference
A De Novo is won not by drafting documents but by strategic FDA communication and a rigorous demonstration of safety and effectiveness. With real FDA-interaction experience on innovative and emerging-technology devices, LK Consulting knows how to articulate your product's distinctive characteristics and clinical value persuasively. We stand beside you at every stage—from initial feasibility assessment to FDA submission and follow-up responses.
The FDA Pre-Submission (Q-Sub) is a valuable opportunity to align with the FDA—on regulatory direction, testing strategy, clinical and non-clinical study plans, and clearance feasibility—before making a formal marketing submission. LK Consulting crafts an FDA meeting strategy suited to your product and development stage, and manages the entire Pre-Submission process so you come away with feedback that truly moves your program forward.
Consulting Service Scope
•Assessment of the product-specific regulatory pathway and the need for a Q-Sub
•Development of the Questions for FDA strategy
•Support with preparing the Pre-Submission package
•Organization of the Device Description and testing plan
•Review of non-clinical and clinical study strategy
•Support with framing FDA questions related to Software, AI, and Cybersecurity
•Support with Teleconference and In-Person Meeting preparation
•Analysis of FDA feedback and development of follow-up strategy
•Advisory on regulatory strategy linked to 510(k) and De Novo pathways
•Support with Additional Q-Subs and follow-up meetings
The LK Consulting Difference
A Pre-Submission is far more than a preliminary meeting—it directly shapes the course of your future FDA review and clearance strategy. The quality of the FDA's feedback, and of the strategy you build on it, depends heavily on which questions you ask and how you frame them. Drawing on extensive first-hand FDA-interaction experience, LK Consulting delivers strategic Q-Sub support attuned to your product's characteristics and likely review issues—serving as your practical regulatory partner from the earliest stages of development through clearance strategy, testing direction, and FDA communication.
Breakthrough Device Designation is an FDA program offering priority review and dedicated interaction for innovative devices with the potential to treat or diagnose life-threatening or irreversibly debilitating conditions more effectively. LK Consulting evaluates your product's Breakthrough potential based on its technical characteristics and clinical value, and provides strategic application support built around FDA expectations.
Consulting Service Scope
•Assessment of Breakthrough Device Designation eligibility
•Review of regulatory and clinical strategy
•Development of the rationale and supporting evidence for FDA submission
•Support with articulating the technology's innovation and differentiation
•Support with preparing and submitting the Breakthrough Designation Request
•Support with responding to FDA questions and preparing additional information
•Advisory on strategy linked to De Novo, 510(k), and the Total Product Life Cycle Advisory Program (TAP)
•Support with follow-up FDA meetings and regulatory communication
The LK Consulting Difference
Breakthrough Device Designation is not awarded for innovative technology alone. What decides the outcome is a logical demonstration—framed from the FDA's perspective—of the potential for clinically meaningful improvement over existing treatment or diagnostic options. With real FDA-interaction experience on innovative and emerging-technology devices, LK Consulting knows how to present your product's characteristics and clinical value persuasively. We provide practical regulatory support at every step, from initial eligibility assessment to FDA submission and follow-up responses.
A Drug Master File (DMF) is the FDA mechanism for submitting confidential technical information—covering raw materials, manufacturing processes, packaging, and storage—and is used primarily for active pharmaceutical ingredients (APIs), excipients, packaging materials, and related components. The DMF safeguards proprietary manufacturing know-how while serving as a reference during the review of related product applications. LK Consulting supports DMF strategy development and document preparation aligned with FDA requirements, tailored to your product and supply structure.
Consulting Service Scope
•Advisory on FDA DMF registration strategy
•Review of Type II, III, IV, and V DMF classification
•Support with preparing and organizing DMF submission documents
•Support with organizing manufacturing process and raw material information
•Review of facility and supply chain information
•Support with FDA eCTD submission files
•Support with preparing the Letter of Authorization (LOA)
•Support with new DMF registration and updates
•Support with Annual Updates and change management
The LK Consulting Difference
A DMF is not simply a data submission—it is the disciplined management of confidential manufacturing information in ongoing alignment with FDA requirements. The structure and completeness of your DMF can directly influence the outcome of a future NDA, ANDA, or medical device review. Taking a holistic view of your manufacturing process, supply chain, and regulatory obligations, LK Consulting delivers practical, efficient DMF support—reliably, across the full lifecycle from initial registration to FDA responses and ongoing maintenance.
The U.S. FDA's UDI (Unique Device Identification) system governs the identification and traceability of medical devices, with the required information registered in the FDA's GUDID (Global Unique Device Identification Database). Notably, shipments are increasingly being held at U.S. import clearance when GUDID registration is missing. LK Consulting provides expert regulatory support at every stage—from a UDI strategy tailored to your product and FDA requirements, through GUDID registration and ongoing maintenance.
Consulting Service Scope
•Review of FDA UDI applicability and regulatory requirements
•Advisory on UDI regulations and Labeling strategy
•Review of the DI (Device Identifier) and PI (Production Identifier) structure
•Support with GUDID account creation and system setup
•Support with new FDA GUDID registration and submission
•Support with registering product information and Packaging Configuration
•Review of Labeler DUNS and related information
•Review of UDI Label and Barcode requirements
•Support with GUDID information corrections and updates
The LK Consulting Difference
UDI and GUDID registration is far more than data entry—it demands a precise understanding of your product's identification structure and the governing FDA regulations. The right strategy varies with product configuration, packaging units, and model management approach, and inaccurate registration can create problems at import clearance and in market distribution.
With hands-on experience across a wide range of medical device categories, LK Consulting develops UDI and GUDID strategies fitted to your product and business structure—and provides dependable regulatory support from initial registration through change management and ongoing maintenance.
