Communicating During the Medical Device Submission Process

Key Points

Domestic manufacturers introducing a medical device to the U.S. market are required to undergo the medical device submission process.
Certain Class I or II devices can be marketed for the first time without having to submit a 510(k).
Once you send your 510(k) submission to the FDA, you can expect an acceptance review, an substantive interaction, and an interactive review before your device can be cleared to market in the U.S.

FDA Submission Requirements for Premarket Notification 510(k)

An 510(k) submission requires you to submit documentation and data demonstrating that your medical device has substantial equivalence to another U.S. marketed device. Substantial equivalence means that your device is as safe and effective as the predicate.

A substantially equivalent device has:

The same intended use as the predicate and;
The same technological characteristics as the predicate device or;
The same intended use as the predicate and;
Different technological characteristics that don’t raise different questions of safety and effectiveness

Claiming that your device is substantially equivalent to another device on the market doesn’t mean it’s required to be identical to the predicate—it just needs to be as safe and effective for the patient. The FDA determines your device’s safety and effectiveness by reviewing scientific methods used to evaluate differences in technological characteristics and performance data. To prove that your device is safe and effective, the FDA expects you to submit clinical data and non-clinical bench performance data, including engineering performance testing, sterility, electromagnetic compatibility, software validation, and biocompatibility evaluation.

Who’s Required to Submit a 510(k)?

The following four types of medical device companies are required to send in a 510(k) submission to the FDA:

Domestic manufacturers introducing a medical device to the U.S. market
Specification developers introducing a device to the U.S. market
Repackers or relabelers who make labeling changes or whose operations significantly affect the device
Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market

When Is a 510(k) Submission Not Required?

The following are examples of when a 510(k) is not required:

You sell unfinished devices to another company for further processing.
You sell medical device components to be used in the assembly of devices by other companies.
Your device isn’t commercially marketed or distributed.
You distribute another firm’s domestically manufactured device.
Your device was legally in commercial distribution before May 28, 1976 and hasn’t been changed or modified in design, components, manufacturing, or intended use.
You’re an importer of medical devices manufactured outside of the U.S.

Certain Class I or II devices can also be marketed for the first time without having to submit a 510(k).

FDA Communications Guidance for a 510(k) Submission

Once you send your 510(k) submission to the FDA, you can expect the following communication methods to occur during the medical device submission process:

Acceptance Review Communication

An acceptance review occurs within 15 days of the FDA receiving your 510(k) submission. The goal of the acceptance review is to identify the FDA’s lead reviewer or regulatory project manager assigned to your submission and confirm or deny submission acceptance. If your submission isn’t accepted for FDA review, you’ll be notified during this step of the medical device submission process. To ensure your submission is accepted, review the FDA’s policies on refusing to accept a 510(k) submission.

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Substantive Interaction

The substantive interaction process involves the FDA communicating one of the following:

Notifying the submitter that staff intends to continue working with the applicant to resolve any outstanding deficiencies during the interactive review process or;
Notifying the applicant that their submission will be placed on hold due to deficiencies that require a solution before the submission can move forward in the medical device submission process

Substantive interaction occurs within 60 days of receiving a complete submission for 510(k) clearance.

Interactive Review

The interactive review process ensures an efficient and timely FDA evaluation of your premarket submission. You can expect the FDA to communicate with you through emails, faxes, and phone calls to prevent unnecessary review completion delays to reduce your device’s time to market. To ensure your interactive review process is efficient, make sure to:

Submit a well-organized, scientifically complete submission that’s consistent with applicable regulations
Include complete contact information in your submission’s cover letter, including name, email address, phone, and fax number
Apply appropriate material or testing standard(s) and submit the necessary declarations or data to support the use of the standard(s)
Provide a complete response to all deficiencies communicated during the interactive review within the FDA-allotted time frame

The FDA’s goal is to make a final decision for 510(k) clearance within 90 days of receiving the submission. When a decision is made, the FDA issues the decision letter to the submitter by email to the email address provided in your cover letter. If the FDA finds that your device is substantially equivalent to its predicate, your 510(k) is cleared by the FDA and added to their 510(k) database.

Helping You Navigate the Medical Device Submission Process

Remington has been through the premarket submission process for our own line of disposable medical devices, so we know a thing or two about the medical device submission process. Whether you want to launch something new or update what already exists, we take care of everything, from conception to registering with the FDA, to ensure everything succeeds according to plan. Contact us today to learn more.