510(k) & FDA Guidance Consulting

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What is 510(k)?

A 510(k) is a premarket submission required by the Food and Drug Administration (FDA) for certain Class I, II, and Class III medical devices (for which a Premarket Approval application (PMA) is not required) before the medical device can be marketed in the United States. The process is named after the section of the Food, Drug and Cosmetic Act that describes it (21 U.S.C. § 360(k)) and it is also known as “Premarket Notification” or “PMN”. The process is intended to provide reasonable assurance of safety and effectiveness.

The 510(k) process requires the medical device manufacturer to submit a premarket notification (510(k)) to the FDA, demonstrating that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device). The 510(k) must demonstrate that the device to be marketed has the same intended use and the same technological characteristics as the predicate device or has different technological characteristics but demonstrates that the device is as safe and effective as the legally marketed device.

A 510(k) is required when a new medical device, never cleared before, is intended to be introduced into the market, or a change is made to a legally marketed medical device that could significantly affect its safety or effectiveness.

510(k) Submission Types

There are four types of 510(k) submissions that medical device manufacturers can make to seek product approval in the US from the FDA: Traditional, Special, Abbreviated, and Safety and Performance Based Pathway. Each type of submission has specific requirements and is used for different purposes.

510(k) Timeline: The time required to prepare a 510(k) submission varies based on the device’s complexity and the type of submission. Simpler devices with well-established predicates may have shorter timelines, while complex devices requiring extensive testing take longer. Traditional 510(k)s generally require the most time, whereas Special and Safety and Performance Based 510(k)s can be prepared more quickly if they align with existing regulatory expectations. Key factors influencing submission timeline include data availability, the extent of modifications, and the need for additional studies.

FDA Review Timeline: The FDA generally aims to review and decide on Traditional, Abbreviated, and Safety and Performance Based 510(k) submissions within 90 days, whereas a Special 510(k) may be reviewed within 30 days. However, it is important to note that actual review timeline can vary, and in some cases, the process may take longer than the listed timeframe due to additional FDA requests or the complexity of the submission.

Traditional

A Traditional 510(k) is a premarket notification submitted to the FDA for a medical device that has a legally marketed predicate device to which the device can be considered substantially equivalent (i.e., device is as safe and effective as the predicate). A Traditional 510(k) can be used for a device not cleared by the FDA before or for a change to a previously cleared device under 510(k).

Special

A Special 510(k) is a premarket notification submitted to the FDA for a manufacturer’s existing legally marketed medical device cleared via 510(k) which underwent modifications. The existing medical device with modifications may be appropriate for the Special 510(k) submission pathway if the manufacturer uses well established methods to demonstrate that the modification does not affect the device’s safety or effectiveness, and is dependent on whether the results can be reviewed in a summary of risk analysis format. Examples of changes that can be submitted as a Special 510(k) can be found in the FDA guidance The Special 510(k) Program.

Abbreviated

An Abbreviated 510(k) is a premarket notification submitted to the FDA for a medical device which relies on FDA guidance documents, special controls, and voluntary consensus standards. An abbreviated 510(k) submission must still meet the requirements defined in 21 CFR 807.87, but manufacturers can provide summary reports on the use of FDA guidance documents, special controls, and voluntary consensus standards to facilitate FDA’s review of the submission.

Safety and Performance Based Pathway

The FDA also provides an optional pathway for certain medical devices expanding on the concept of the Abbreviated 510(k) Program. The pathway is called the Safety and Performance Based Pathway. For certain medical devices, the FDA has identified performance criteria to demonstrate the device’s safety and effectiveness. Instead of proving substantial equivalence to a predicate device, manufacturers can establish the safety and effectiveness of their medical device by meeting the identified performance criteria for the device. The manufacturer is still required to identify a predicate device to demonstrate that the device under development has the same indications for use as the predicate and the technological characteristics do not raise different questions of safety and effectiveness that the predicate. The list of device types that qualify for the Safety and Performance Based Pathway and the guidance documents that identify the performance criteria for each device type is maintained on the FDA’s website. For more details, see the Safety and Performance Based Pathway guidance document.

Traditional 510(k) Submission Process

Overview

A Traditional 510(k) submission requires a manufacturer to provide evidence that their medical device is substantially equivalent to a legally marketed device, also referred to as a predicate. The submission requires a comparison between the device to be marketed and the predicate device or devices.

Finding a Predicate Device

A primary predicate device that is most similar to the device intended to be submitted through the 510(k) program should be identified based on similar indications for use and technological characteristics.

A predicate device can be identified by searching the FDA databases, 510(k) Premarket Notification and De Novo. There are several ways to search for a predicate device using these databases such as searching by submission number (De Novo, 510(k)), device name, decision date, and product code. However, searching for predicate devices by product code is usually most effective while leaving other boxes blank per FDA’s suggestion. The product code and classification regulation for devices can be found by searching the FDA’s Product Code Classification Database. Additional information on classifications and product codes can be found under Classify Your Medical Device on the FDA website.

Prepare Traditional 510(k) Submission

A 510(k) submission must include information required under 21 CFR 807.87 and 21 CFR 807.90. Additional information on content and format of a Traditional 510(k) can be found in the FDA Medical Device 510(k) Submissions guidance document.

Submission of Traditional 510(k)

A Traditional 510(k) submission can be submitted as an eCopy or eSTAR.

The FDA defines eCopy as an electronic version of the medical device submission created and submitted on a compact disc (CD), digital video disk (DVD), or a flash drive. The submission is accompanied by a paper copy of a signed cover letter. Detailed information on eCOPY can be found in the eCOPY Program for Medical Device Submissions guidance document.

eSTAR allows manufacturers to submit a 510(k) submission via an interactive PDF form. With a standardized format, submitters ensure their submission is complete and the FDA can review the submission more efficiently to help promote timely access to safe, effective, and high-quality medical devices. Detailed information on eSTAR can be found under Voluntary eSTAR Program on the FDA website.

A 510(k) user fee will be required to be paid before the submission. Detailed information on the user fee can be found under Medical Device User Fees on the FDA website.

Special 510(k) Submission Process

Overview

A Special 510(k) submission is intended to facilitate review and approval of a change to a manufacturer’s existing device that is already authorized for commercial distribution by the FDA.

Special 510(k) Submission Requirements

The manufacturer needs to ensure that the information for a device being submitted to the FDA for review is the manufacturer’s own legally marketed device as the FDA will rely on previously reviewed detailed information regarding the device being modified.

The manufacturer then needs to determine whether performance data is needed to evaluate the change. In some cases, verification and validation testing may be necessary to support changes in indications for use and design. The agency expects the results of verification and validation activities to be summarized in a risk analysis format without losing the information necessary to support substantial equivalence.

If the manufacturer determines that performance data is not required, meaning that no additional verification and validation testing is necessary to evaluate a change that otherwise requires submission and clearance of a 510(k), these changes to the device may be submitted as a Special 510(k). Clear rationale must be communicated when performance data is not included.

Additionally, to qualify for the Special 510(k) program, the FDA expects summary information generated from well-established methods, rather than complete test reports. Examples of well-established methods can be found in The Special 510(k) Program guidance document.

More details on eligibility and additional considerations can be found in The Special 510(k) Program guidance document.

Prepare Special 510(k) Submission

A Special 510(k) submission must include information required under 21 CFR 807.87 and 21 CFR 807.90. Additional information on requirements and content can be found in the FDA guidance document entitled The Special 510(k) Program. Additional information on submission formatting can be found under 510(k) Format Tips on the FDA website.

Submission of Special 510(k)

A Special 510(k) submission must be submitted in an eCopy format. Detailed information on eCopy can be found in the eCOPY Program for Medical Device Submissions guidance document.

A 510(k) user fee will be required to be paid before the submission. Detailed information on user fee can be found under Medical Device User Fees on the FDA website.

Abbreviated 510(k) Submission Process

Overview

In an Abbreviated 510(k) submission, manufacturers provide summary reports based on the use of guidance documents and/or special controls, or declaration of conformity to recognized standards.

Abbreviated 510(k) Submission Requirements

According to the FDA, the device manufacturer may choose to submit an Abbreviated 510(k) when the submission relies on one or more:

FDA guidance documents
Demonstration of compliance with special controls for the device type, either in a device-specific classification regulation or a special controls guidance document; and/or
Voluntary consensus standard(s)

The reports generated based on the guidance documents above should summarize the device description, device design requirements, risk management information, and a description of test methods used to address performance characteristics.

Prepare Abbreviated 510(k) Submission

An Abbreviated 510(k) submission must include information required under 21 CFR 807.87 and 21 CFR 807.90. Additional information on content and format of an Abbreviated 510(k) can be found in the Abbreviated 510(k) Program and Medical Device 510(k) Submissions guidance documents.

Submission of Abbreviated 510(k)

An Abbreviated 510(k) submission must be submitted in an eCopy format. Detailed information on eCopy can be found in the eCOPY Program for Medical Device Submissions guidance document.

A 510(k) user fee will be required to be paid before the submission. Detailed information on user fee can be found under Medical Device User Fees on the FDA website.

Safety and Performance Based Pathway

Overview

The Safety and Performance Based Pathway is used for certain, well understood device types. The manufacturer needs to demonstrate that the medical device intended to be marketed meets FDA identified performance criteria to demonstrate that the device is as safe and effective as a predicate device.

Safety and Performance Based Pathway Submission Requirements

The FDA defines the following criteria to be eligible for the Safety and Performance Based Pathway:

The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than, the identified predicate; and
The new device meets all the FDA-identified performance criteria.

Prepare Safety and Performance Based Pathway Submission

Some of the FDA’s recommended content for the Safety and Performance Based Pathway includes:

Declaration of Conformity
Results Summary of performance testing
Testing Protocol of performance testing
Complete Test Report of performance testing

More details on the submission content can be found in the Safety and Performance Based Pathway guidance document.

Submission of Safety and Performance Based Pathway

An Abbreviated 510(k) submission must be submitted in an eCopy format. Detailed information on eCopy can be found in the eCOPY Program for Medical Device Submissions guidance document.

A 510(k) user fee will be required to be paid before the submission. Detailed information on user fee can be found under Medical Device User Fees on the FDA website.

Why Choose Innovenn for your 510(k) & FDA Guidance Consulting Services?

By choosing Innovenn’s 510(k) consulting services, medical device manufacturers can benefit from our experience and knowledge of the regulatory requirements and understanding of the expectations of the FDA. Innovenn’s consulting team can provide valuable insights into how to strategically position your device for success.

To learn more about Innovenn’s 510(k) & FDA guidance consulting services, contact us to discuss your specific needs.

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