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510k Submissions | Medical Device Registration

Submitting a 510(k) application to the FDA for your medical device can be a stressful and complicated process. Luckily, there are a few tips and tricks you can use to make the submission process easier and increase the likelihood of your device being approved.

Get assistance with medical device 510(k) premarket submissions from an FDA expert at Quality Smart Solutions. Are you looking for an FDA 510(k) consultant? You’ve come to the right place! We have years of experience helping companies navigate the process of obtaining regulatory clearance for their medical devices.

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What are Medical Device 510k Submissions?

A 510(k) is a Premarket Notification for medical devices submitted to the FDA. It demonstrates the device is as safe and effective for human use as the legally marketed device that is not subjected to Pre-market Approval (PMA). 510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act (FD & C Act). The FDA 510(k) program allows manufacturers to submit premarket notification (PMN) applications to the agency in order to market new products that are substantially equivalent to existing approved products.  It takes careful evaluation, effective collaboration, and diligent accuracy to file a successful document with the U.S. Food and Drug Administration (FDA).  Submitting a 510(k) can be a complex process, and it’s important to make sure you have all the necessary information ready before submitting. In this guide, you’ll find out what questions to ask, what documents to prepare, and how to make sure your submission is compliant.

Who should submit a 510(k)?

Any business or individual who manufactures a Class II or III medical device is required to submit a 510(k). A Class III device is one that typically sustains or supports the life of the patient, such as a pacemaker, implantable infusion pump, etc. While there are certain exceptions to this rule, it’s best to check with the FDA directly regarding which devices require a 510(k) submission.

What is the 510K Submission Process?

The process of submitting a 510(k) consists of three basic steps: application, review, and decision. During the application process, you will provide all applicable information on your device and its intended use. During the review period, your device must be tested and evaluated against certain FDA performance criteria. Once all required components have been submitted, the FDA will make its final decision. After the 510(k) is approved, it typically becomes effective within 30 days.

Medical Device 510(k) Submissions at Quality Smart Solutions

Make Medical Device FDA 510(k) Submissions convenient and hassle-free with the help of former FDA officials at Quality Smart Solutions. We offer quality support to businesses seeking 510(k) submission assistance. We help:

Determine FDA Clearance

Determine which predicate (similar) device already has FDA 510(K) clearance and whether it is suited for 510(k) submission.

Review Testing Requirements

Get help from our professionals in reviewing testing requirements, applicable FDA guidelines and documents and standards.

Product-Specific List

Get a detailed product-specific list of documents required for review from our FDA 510(k) consulting professionals.

List of Documents & Reports

We prepare and provide a complete list of reports, documents, diagrams or clinical data before 510(k) preparation begins.

Technical Comparison

With us, you can easily prepare a technical comparison of your medical device to other devices with FDA 510(k) Clearance.

Interaction with Agency

We interact with agencies during the FDA 510(k) submission process to get your medical devices registered

What is a 510k Medical Device Premarket Notification?

A 510(k) is a Premarket Notification for medical devices submitted to the FDA. It’s premarket submission to the Food and Drug Administration (FDA) to demonstrate that the device is as safe and effective for human use as the legally marketed device that is not subjected to Pre-market Approval (PMA). The reason why a particular medical device is 510(k) is that 510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act (FD & C Act). Before submitting the 510(k), you may need to provide evidence that your product is safe and effective. The FDA may require pre-clinical or clinical studies to provide such evidence. Depending on the product, these studies could involve tests on animals or humans. Be sure to contact the FDA for specific information about the type and scope of testing required for your device.

Understand FDA Requirements for 510k submissions:

Before you can submit your Medical Device 510(k) application to the FDA, it is important to understand the FDA’s requirements and guidelines. Applications must include detailed information about your device, such as its intended use and components, so that the FDA can assess whether or not it meets all applicable safety and performance standards. Additionally, complete and accurate labeling with clear instructions for use should also be provided. This information will help the FDA evaluate your device before granting approval.

5 Steps to Conducting FDA 510 Submissions Review | 510k Review Timeline

An FDA 510(k) review can be a lengthy process. But if you follow these tips, you’ll have a better chance of getting approval.  The Food and Drug Administration (FDA) has approved many medical devices that are used in hospitals and clinics. These devices must undergo an extensive review before being allowed on the market. This process is called FDA 510(k) review.  Our compliance specialists can help make this process easy for you.

  1. We understand the process
  2. Can prepare your application
  3. Submit your documents
  4. Follow up with the FDA
  5. Respond to comments from the FDA

Timelines for FDA review of 510 submissions

The length of time for review of a 510(k) submission can vary from 3 to over 12 months.  This depends on whether an additional information (AI) letter is issued by the FDA or if a Refuse to Accept (RTA) is issued.   The complexity of the device (typically higher class devices are more complex and have more data than lower class devices) can also contribute to this timeline.  FDA’s service standard is set at 90 calendar days. However, whenever an AI letter is issued the review “clock” is paused until there is an answer.  Up to 180 calendar days are given to respond to the AI.  So, if the maximum time is taken to respond to each AI it can take a very long time to get final clearance from FDA.  It’s imperative that responses happen quickly so the clock resumes.

Why should i hire FDA 510 submissions consultant?

There are several reasons why you should hire an FDA 510(k)-consultant. First, we will help you understand what the FDA 510(k) process is and how it works. Second, we will assist you with navigating the FDA 510(k), so that you can focus on growing your business instead of spending time on administrative tasks. Third, we will provide you with expert advice on how to prepare your PMN application. Fourth, we will ensure that your PMN application is submitted within the required timeframe. Fifth, we will work closely with you throughout the entire process to make sure that everything goes smoothly. Sixth, we will keep you updated on any changes to the FDA 510(k). And finally, we will help you avoid costly mistakes.

Submission Plan & Your Regulatory Strategy

Creating a comprehensive plan will help you map out the steps required to successfully submit an application. This includes gathering all relevant device data, test results, and safety reports; determining any applicable FDA regulations and standards; and planning review and submission timelines. Additionally, if your device is being marketed internationally, it is important to familiarize yourself with the requirements in those countries so that you can ensure that your device meets all necessary criteria.

When submitting a 510(k) application, it is important to create a regulatory strategy. This should include identifying any applicable FDA regulations and standards that your device needs to meet, as well as understanding the specific requirements for your type of product. Additionally, you will need to determine the most suitable submission process and pathway, such as traditional or abbreviated 510(k), Special 510(k), or notified body review/certification. Knowing which pathway works best for your device will ensure a successful and timely submission.

Medical Devices 510k Submissions FDA Clearance

If you want to market Class I, Class II, and Class III devices in the US market for which a Premarket Approval application (PMA) is not required, you must submit US FDA 510(k). Most of the Class I devices are excluded from 510(k) requirements.  If the authority finds, during the review of the 510(k) file, that the device is Substantially Equivalent (SE), it will give clearance with a ‘k’ number. Meeting SE proves that the medical device is as safe and effective as the predicate device (legally marketed device in the USA).

How to choose the best 510k Medical Device Consultant?

When choosing the right 510k Medical Device Consultant, there are several considerations to make.

  • Choose a consultant with a good track record. When researching consultants, take note of their success rate and reputation within the industry. The best consultants have years of experience in helping companies navigate the complex FDA 510k process and successfully bring their products to market.

  • Choose a consultant with a good reputation. Due diligence is essential to finding the right medical device consulting company for your needs; look at online reviews from clients who have worked with this company before you hire them for your project. The best medical device consulting firms will always strive to provide excellent client service and deliver on time every time – both of these things can be easily verified through customer feedback online!

  • Choose a consultant that is licensed and insured. This step may seem obvious but it’s still important to verify that any potential candidate has all of the required permits before signing any contracts or working together on your project moving forward (especially since this type of work involves communicating directly with federal agencies). You should also confirm that they have proper liability coverage in case something goes wrong during production or testing phases which could lead directly back down those same roads again later on down the life cycle timeline.”

Frequently Asked Questions - FDA Registered 510 k Medical Device

A 510(k) is a Premarket Notification for medical devices submitted to the FDA. It’s premarket submission to the Food and Drug Administration (FDA) to demonstrate that the device is as safe and effective for human use as the legally marketed device that is not subjected to Pre-market Approval (PMA). The reason why a particular medical device is 510(k) is that 510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act (FD & C Act). 

If you want to market Class I, Class II, and Class III devices in the US market for which a Premarket Approval application (PMA) is not required, you must submit US FDA 510 (k). Most of the Class I devices are excluded from 510(k) requirements.  If the authority finds, during the review of the 510(k) file, that the device is Substantially Equivalent (SE), it will give clearance with a ‘k’ number. Meeting SE proves that the medical device is as safe and effective as the predicate device (legally marketed device in the USA).

The length of time FDA 510(k) reviews can vary from 3 to over 12 months.  This depends on whether additional information (AI) letter is issued by FDA or if a Refuse to Accept (RTA) is issued.   The complexity of the device (typically higher-class devices are more complex and have more data than lower class devices) can also contribute to this timeline.  FDA’s service standard is set at 90 calendar days. However, whenever an AI letter is issued the review “clock” is paused until there is an answer.  Up to 180 calendar days is given to respond to the AI.  So, if the maximum time is taken to respond to each AI it can take a very long time to get final clearance from FDA.  It’s imperative that responses happen quickly so the clock resumes.  

  1. Help determine FDA clearance
  2. Review Testing Requirements
  3. Create the required product-specific list of documents
  4. Preparing and providing the list of reports, documents, and clinical data
  5. Technical comparison
  6. We interact with agencies during the registration process

Registering establishments (owners or operators of places of business) with the FDA annually is a must for every domestic, foreign manufacturer and initial distributor or importer of medical devices. It is obligatory for every importer of medical devices to US to provide FDA with the medical device facility establishment number for foreign drug manufacturers and importers/distributors.

Failure to do this results in delay or refusal of medical devices. Registering establishments or facilities with FDA is known as establishment registration. Click to learn about 510(k) Medical Device Registration. 

FURLS is an acronym for FDA Unified Registration and Listing System. It is a system created by the FDA to help applicants register through the online system and make electronic submissions. With FURLs, you can view and edit your applications even after submission. Registration and listing information is submitted by using the FDA’s Unified Registration and Listing System (FURLS).

These facilities are typically business establishments that are required to register each year with the FDA.  These facilities are usually involved in the production and distribution of devices for medical use within the U.S.A.

Registration of Medical Device Establishments occurs through the FDA Unified Registration and Listing System (FURLS)! Below are things you should know:

  • As an owner or operator, having a valid login ID and password to access the FURLS is a must​
  • As an owner or operator, you must obtain an annual registration​
  • In case of official correspondent, owner or operators must create a separate sub-account for any communication

FDA has established FURLS to advance electronic submissions

FDA approval ensures device safety and effectiveness, instilling confidence in healthcare professionals and patients and protecting manufacturers from liability. It signifies that the device meets stringent regulatory standards and is suitable for its intended use.

Benefits include faster market entry, lower costs, increased confidence, and a competitive edge, vital for a medical device’s success. Successful submissions expedite commercialization, reduce development expenses, and enhance market acceptance.

FDA approvals include 510(k), PMA, and De Novo processes, each catering to different device risk levels and submission requirements. 510(k) is for moderate-risk devices, PMA for high-risk ones, and De Novo for devices without predicate device equivalents.

Navigating the complex submission process is simplified with expert guidance, ensuring compliance and increasing the likelihood of success. Consultants offer specialized knowledge, experience, and resources to streamline the submission process and mitigate regulatory risks.

Choosing a consultant with proven success, expertise in the device’s category, and familiarity with FDA guidelines is crucial for success. Manufacturers should evaluate consultants based on their track record, industry reputation, and ability to provide tailored solutions.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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