510(k) Submissions
Streamlined Submissions for Faster FDA Clearance
We guide you through the regulatory submission process with our extensive regulatory expertise. Whether you are seeking 510(k) clearance, PMA approval or De Novo classification, our team knows the process, requirements and methods of expedition, which means we can get your device through the process as efficiently and quickly as possible.
Why It Matters
The 510(k) process is complex and demanding. Without a proven strategy, it can be very time-consuming and more costly than it needs to be. Our team of experts will help you to organize your submission and select appropriate predicate medical device(s) to serve as its backing. We will address FDA requirements from the start of your development - as early as the design phase - to prevent potential process hurdles.
The financial impact of submission delays extends well beyond FDA user fees. A month's delay can cost hundreds of thousands of dollars in lost opportunity and revenue, especially in competitive markets where the first to market often captures the majority of the market share. Additional Information requests or Refuse to Accept letters may add additional six to twelve months onto your final approval time.
FDA reviewers examine submissions with heavy scrutiny and are seeking thorough, organized and completed documentation. Successful 510(k) submissions require in-depth technical documentation, solid predicate comparisons, and detailed testing and risk analysis documentation.
Our Approach
Planning for clearance from the start
We approach submission planning with years of experience, having obtained hundreds of regulatory approvals for our clients. Throughout the device’s development, we build and collate all of the data needed for the submission package so that you are prepared and ready for approval.
Clearance from the concept stage
Our regulatory strategy development starts before the concepting stage. This up-front philosophy helps steer the design decisions with regulatory clearance in mind. We conduct extensive research on predicate devices to identify the most ideal comparison devices, and then develop our equivalence argument that will be needed to support submission.
Pre-submission meetings
We keep FDA reviewers actively engaged through pre-submission meetings to ensure that our submission plan is consistent with current FDA expectations. Our team of experts stay up to date with new guidance documents and reviewer preferences for all device classes.
Thorough documentation
The HaA PD team ensures that quality is at the core of everything we do. Before submitting, our regulatory team reviews all outlines several times internally prior to submission. We also anticipate questions that the FDA may have in advance and prepare for them proactively.
Risk Management Integration
Risk management means ensuring your device is safe and is prepared for regulatory review. We create comprehensive risk management reports that anticipate device-related hazards and we address them. Risk analysis backs every design decision and is a core foundation of our substantial equivalence arguments.
Post-market risk management is another key area that requires a solid strategy. We create risk management monitoring frameworks that help with submission requirements and with ongoing requirements post commercialization. This approach meets FDA requirements and prepares your medical device for successful post-market surveillance.
Our 510(k) Submission Services Include:
Pre-Submission of Guidance & Documentation - A strategic FDA engagement with which to clarify requirements and optimize your submission strategy.
Predicate Device Analysis and Comparison - Extensive research, clinical trials, and analysis of the device to determine the best predicate devices and build strong equivalence arguments.
Substantial Equivalence Justification - A detailed technical and clinical document proving safety and effectiveness equivalence.
Safety and Performance Documentation - Testing documentation that is FDA compliant and also provides supporting regulatory evidence.
Regulatory Strategy and Communication with FDA - Active and continual FDA communication and strategic expertise through the entire regulatory submission process.
Full HF/UE Documentation Package - Complete human factors and usability engineering documentation required for regulatory submission.
Labeling & Instructions for Use (IFU) - FDA-approved labeling that helps ensure complete, safe, and effective device usage.
Risk Management File - A complete and finished ISO 14971 compliant risk management documentation form.
What You Get
We provide you with a complete, submission-ready regulatory package that includes all required documentation and data. Our process prepares your device for quick and efficient approval.
Our submissions are prepared for the FDA reviewer based on our team's expertise and includes tips to expedite FDA review. We will guide you every step of the way with our industry and regulatory insight and advice that is always up to date. We will provide you with any FDA requirement changes that are related to your device category.
Our clients achieve better-than-average first submission approval rates.. The end result of working with our team of experts is faster entry into the market, fewer unexpected regulatory costs, and the guarantee that your device clearance will stand up to post-market surveillance.
Contact HaA Product Development today and let us help you bring your vision to life!