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510(k) Submission
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U.S. FDA 510k Clearance

FDA 510k clearance is one of the most critical parts of the process to bring medical device to the U.S. market. Considering how crucial the 510(k) is for medical device companies, it is vital that they properly streamline the 510(k) submission process. Our expertise and support come into play at this juncture.

At Elexes, we have the best FDA regulatory consultants who have decades of experience in getting 510(k) clearance for several different medical devices. We assist medical device companies in conducting thorough gap analysis pertaining to their 510(k) submissions and facilitate the resolution of identified gaps to expedite and streamline the process.

Our FDA regulatory consultants will carefully deploy time-tested best practices at each step of the FDA 510k clearance process maximizing the likelihood of getting market clearance for your medical device, without any delay.

Our Expertise

Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.

Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

Do you need a 510(k) clearance?

If you are wish to sell a Class II medical device or an IVD in the United States, filing a Premarket Notification [510(k) submission] with the U.S. Food and Drug Administration (FDA) is essential. Not just Class II devices, but some Class I and unclassified devices also require a 510k clearance by FDA.

In addition to this, if you are making a significant change to the intended use, technological characteristics, materials, etc. in your already cleared medical device, you are required to resubmit the FDA 510k application.

To know if your device needs 510(k) clearance, you can contact our team of FDA regulatory consultants, and one of our experts will help you accurately classify your product and determine whether you need to go through the 510(k) submission process or not.

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Elexes 510(k) Consulting Process

Step 1

Evaluating 510(k) requirements, documentation review & Gap analysis

⦿ Determining the proper FDA code and regulation number by understanding the proposed intended use as well as technology features. This help us point to the device specific guidance documents and standards that are needed for for timely 510(k) clearance for your medical device.

⦿ Determining the equivalence for the device (Predicate device) by evaluating similar devices that have already received 510(k) clearance.

⦿ After determining the FDA code, regulation standard, and predicate device, we provide manufacturers with the list of documents, minimum expected tests, labeling, and information required for 510(k) submission.

⦿ One of our FDA regulatory consultant will review all the information you provide and determine if it is accurate and enough to carry the 510k submission process. At this stage, the 510k consultant will provide a detailed gap analysis report identifying all the missing information that is required for FDA 510(k) submission.

Step 2

510(k) compilation &
FDA submission

⦿ Preparing a technical comparison between your device and the selected predicate device.

⦿ Preparing all the 510(k) application sections and send it for review to your experts before processing it to the FDA.

⦿ Submitting 510(k) electronically to the U.S. FDA and facilitating the further communication with FDA.

⦿ Bridging the communication between the FDA and your experts along with addressing any requests from the FDA for additional information through Acceptance Review, Substantive Review, and Interactive Review of the submission.

Frequently Asked Questions About 510(k) Submission

No, there is no such registration certificate after the 510(k) clearance. Instead, FDA issues a 510(k) clearance letter and post it on their official website which will act as your proof of the 510k clearance.

The FDA’s set time for most 510(k) reviews is 90 days. However, in general it takes around four to nine months and even longer in some cases to get the clearance. This mostly is because of the additional information that the FDA might require. In this case, they put a hold on the 510(k) process and resumes it once they have enough and required information. In most of the cases, you can expect to receive a few questions during the substantial review phase which in turn increases the 510k clearance time. How much time, though, will depend on the number of variables like quality of supporting documentation, predicate device selection, etc.

“FDA cleared” means that medical device has undergone a 510k submission and have received an FDA 510k clearance whereas FDA approval is required for the Class III medical devices and IVDs to be legally marketed. During the FDA approval process they have to undergo the premarket approval (PMA) or a Humanitarian Device Exemption (HDE) process. You can understand the difference between the 510(k) and PMA in our guide 510k vs pma | Explore the difference!

Explore our guide on 13 mistakes that you should avoid while making your 510(k) submission

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Our Compliance Assessment Process

Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.

Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.

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We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.

Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.

Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.

A Trusted Team of Consultants

Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.

Local Language
Auditor

Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.

Why Choose Elexes?

Expertise

Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.

Local Regulatory Certification

At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.

Confidentiality

We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.

Looking for assistance with your 510(k) Clearance?

If yes, our experts have years of experience to offer support for 510(k) submission

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