FDA 510(k) Consulting for Medical Devices

FDA 510(k) Consulting specializes in 510(k) Submission to FDA for medical devices and combination product approval. Our FDA 510k Consultants are experts in FDA medical device regulatory compliance. Our FDA consultants got extensive experience in all aspects of the regulatory compliance processes and successful Medical Device 510k Submission Consulting for FDA Approval, Pre-submissions, Q-Sub, IDEs, and PMA Submissions to FDA.

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Are You Seeking FDA Approval?

FDA 510(k) Consulting have helped several medical devices, pharmaceutical, biologics, biosimilars, and diagnostics companies for over 30 years to get the FDA approval. Our FDA 510k Consultant can handle registration of your device with U.S. FDA, help prepare and submit your company’s medical device 510(k) Submission Consulting for FDA Approval and help your company in getting the required Safety and Effectiveness Testing, Performance Testing, Animal Testing, and Risk Analysis Studies done at significantly lower cost, and help with Clinical Trial Management, Quality Management System, FDA Audits, address Compliance related issues, 483 Observations and Warning Letter Responses to FDA.

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We are the Medical Device FDA 510(k) Experts

FDA Consulting LLC specializes in 510(k) Submission for medical devices and combination product approval.

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About Us

FDA 510(k) Consulting specializes in regulatory and compliance related submission services to manufacturers, importers, and suppliers of medical devices. Our FDA 510k Consultants are experts in medical device 510(k) Submission Consulting for FDA Approval . Our consultants got over 30 years of medical product experience, and familiar with FDA’s medical device product classifications. We are transparent and will make timely and effective regulatory submissions to the FDA for a fixed fee. We ensure to file appropriate notifications and filings for timely approval.

Since FDA 510(k) Consulting got a long-standing relationship working with the FDA and a track record of success in medical device 510(k) Submission consulting for FDA Approval and clearance, we are proud to assist our clients to successfully navigate the 510(k) submission process. As your FDA 510k consultant, some of the services that we provide include evaluating your medical device’s classification, perform GAP analysis, prepare the regulatory strategy, collect the necessary data, safety and performance test report and documentation to complete the 510(k) Submission. As your FDA 510(k) consultant, our goal is to remove the stress and burden of the 510(k) submission work from your shoulders by bringing regulatory and compliance skills, so that you get the desirable outcome from the U.S Food and Drug Administration (FDA) at the end of the submission process.

Regulatory services

Quality System

Testing Services

Clinical Trial Management

Risk Analysis

Manufacturing Services

Why Should I choose
FDA Consulting for my 510(k)?

There may be several factors in your 510k consultant selection process, but you should consider some of the most important factors listed below in your FDA 510k Consultant selection process:

Our team at FDA 510(k) Consulting has over 30 years of Research & Development, Testing, Manufacturing and FDA Regulatory Compliance, medical product industry, sales, marketing, and business experience. So, our FDA 510k Consultant not only understand the product development, safety and effectiveness testing of medical products but also the regulatory side of your submission and FDA approval, marketing, sales, and commercial side of the business. We understand the financial pressure placed client business when trying to comply with FDA regulatory requirements and the cost of having to perform required expensive testing to demonstrate the safety and effectiveness of your medical device to that of a device that is already cleared (your predicate device) by the U.S. FDA. When the 510(k) is cleared, it is important to ensure that the marketing claims (Indications for Use) cleared by the FDA provide your salesforce, dealers, and distributors the necessary sales claims to be competitive in the market. We got several successful medical device 510(k) submission and clearances from different Divisions of the CDRH.

The medical device 510(k) Submission to FDA can be costly and time consuming in some cases due to FDA’s requirements for various safety and efficacy testing, which includes biocompatibility and toxicologytesting, general electrical safety, electromagnetic compatibility, home healthcare, usability, human factor, sterility, sterilization validation, reprocessing validation, shelf-life studies, accelerated aging, real-time aging, package integrity testing and performance test in an animal model and in some cases require a clinical study.

The FDA Consulting has a FIXED FEE STRUCTURE for our consulting services that hopefully will meet your budget. Our fixed fee requires 50% payment to start the project and pay the remaining 50% is due prior to hand delivering your submission to FDA’s Document Control Center in Maryland. There will be NO ADDITIONAL FEES for your 510(k) Submission related consulting work, means NO SURPRISES or NO COST INCREASE for your submission.

The new medical device product development is determined by the demand for that product in the market. It is important to ensure that your product viable to achieve its financial objectives and particularly important to understand what is the regulatory strategy and financial burden to achieve the FDA 510(k) clearance or PMA approval.

It is important for you as the sponsor of the product and we as your FDA Consultant to determine if we are the right consulting firm to assist you with your device FDA clearance. FDA Consulting LLC will perform an initial consulting and search to provide the product code, device classification, and FDA quality system requirements for your device for free.

Yes, location matters. Our company is located in Maryland, Washington DC metro area, which is just 15minutes from U.S. Food and Drug Administration (FDA) headquarters.It is helps in effective communication and if a meeting is required with the reviewer and regulatory agency for the success of your application to provide clarification or interactive review and fast track product approval to market. All the FDA submissions and responses that we handle are hand delivered to the FDA and the submission gets date stamped for receipt at the document room. The FDA has changed their rules on formal request for additional information and review time, in most cases the second responses are done as an interactive review resulting in mere days or sometimes must respond to FDA’s questions in hours. We can actively work with the FDA interactively by being not only in the same time zone but working in the same area.

FDA Consulting LLC keeps all submission, resubmission, communications from FDA, review, request for additional information, and interactive review and responses to FDA transparent.

We serve companies of all size and product classifications within your budget. Please contact us for a quote for your submission.