FDA 510K Medical Device Submissions

Get assistance with medical device 510(k) submissions from an FDA expert at Quality Smart Solutions. We help you by reviewing the requirements to ensure your device meets FDA safety and efficacy standards for premarket submission.

What are 510(k) Submissions?

A 510(k) is a Premarket Notification for medical devices submitted to the FDA. It’s 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). 510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act (FD & C Act). 

Medical Devices 510(k) 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).

Timelines for FDA review of 510(k) 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.

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). 

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

Register Your 510(k) Medical Device Today!

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