Let us now look at each of the above sections in detail.

Section 1: Submission Type

Identification of key information that may be useful to the FDA in the initial processing and review of the 510(k) submission requirements, including content from current Form FDA 3514, Section A.

Section 2: 510(k) Cover Letter / Letters of Reference

The 510(k) cover letter includes a broad summary of the 510(k) submission requirements, including:

• The submission date and the type of 510(k) submission, that is, whether the submission is abbreviated or traditional.
• The submitter’s details (name, address, phone, fax, and e-mail address).
• The common name of the device.
• The establishment registration number.
• The trade name, including the model number(s) of the device.
• Device classification (whether it is a Class I, II, or III device or unclassified).
• The reason for 510(k) (for example, justifying whether it is a new device or a modification to an existing device).
• Identification of the predicate device to which you are claiming SE (provide the 510[k] number for the predicate device, the trade name, and the product code).
• The registration number, name, and address of each facility used to manufacture the finished device (including contract sterilizers and packagers), if applicable.
• Compliance with any special controls.

Section 3: Applicant Information

The 510(k) application must include the information about the applicant and correspondent, if applicable, consistent with content from current Form FDA 3514, Sections B and C.

Section 4: Pre-Submission Correspondence & Previous Regulator Interaction

Information on prior submissions for the same device included in the current submission, such as submission numbers for a prior not substantially equivalent (NSE) determination, prior deleted or withdrawn 510(k), Q-Submission, Investigational Device Exemption (IDE) application, premarket approval (PMA) application, humanitarian device exemption (HDE) application, or De Novo classification request.

Section 5: Consensus Standards

 Identification of voluntary consensus standard(s) used, if applicable. This includes both FDA-recognized and non-recognized consensus standards.

Section 6: Device Description

The device description should include the device’s key technical information, such as the Design History File (DHF), design controls, design outputs, specs, drawings, dimensions, components, material specifications, etc. Provided with the right device description, the US FDA reviewer will become thoroughly familiar with your device, which will, in turn, help set up a stage for Section 9 (Predicates and Substantial Equivalence). Keeping up with design controls and risk management documentation and establishing a Quality Management System (QMS) will make the 510(k) medical device approval process simpler.

 Section 7: Proposed Indications for Use (Form FDA 3881)

In this section, the applicant must prove SE of the indications for use between their device and the 510(k) predicate. The US FDA recommends using the indications for use form for this purpose; the statement should include clinical settings, specific indications, the definition of the target population, anatomical sites, etc., and it must be consistent with your labeling, advertising, and Instructions for Use (IFU). After completing the review, the US FDA will include the indications for use statement along with the SE letter to the applicant and make it available to the public on the Internet within thirty (30) days of making the decision.

Section 8: Classification

Identification of the classification regulation number that seems most appropriate for the subject device, as applicable.

Section 9: Predicates and Substantial Equivalence

Identification of a 510(k) predicate device (e.g., 510(k) number, De Novo number, reclassified PMA number, classification regulation reference, if exempt and limitations to exemption are exceeded, or statement that the predicate is a pre-amendments device).

The submission should include a comparison of the predicate and subject device and a discussion why any differences between the subject and predicate do not impact safety and effectiveness. A reference device should also be included in the discussion, if applicable.

Section 10: Design / Special Controls, Risks to Health, and Mitigation Measures

Applicable to Special 510(k) submissions.

Identification of the device changes and the risk analysis method(s) used to assess the impact of the change(s) on the device and the results of the analysis.

Risk control measures to mitigate identified risks (e.g., labelling, verification).

 Section 11: Labeling

This section must include the device label, patient labeling, instructions for use (IFU), in-package inserts, and operating instructions. At this stage, your Unique Device Identification (UDI) code is not mandatory, but you should include a sample barcode of where it will go. Also, please note that the US FDA considers publishing the device labeling information on the website, too, but it does not allow you to market the device without receiving 510(k) clearance or completing the FDA 510(k) clearance process.

Section 12: Reprocessing

Information for assessing the reprocessing validation and labeling, if applicable.

Section 13: Sterility; Section 14: Shelf Life

If your device is sterile, you should prove its sterility till the end of its shelf life, along with the assurance that it will perform as expected. However, you should make a clear statement if the device is non-sterile. Also, if you are claiming shelf life, you should support the claim with the applicable device testing to exhibit its performance during the claimed shelf life.

Section 15: Biocompatibility

This section is important if your device is in patient contact, directly or indirectly. In such cases, you must include the device’s test protocols and reports for those areas that are in patient contact.

 Section 16: Software / Firmware

If your device does not have any software / firmware, you can state, “My medical device does not have software/electrical components; this section is not applicable.” The device's Level of Concern (LOC) should be established, and the test data must be added accordingly if your device has software/firmware. The device’s LOC will determine the level of documentation required. The higher the device’s LOC, the more the documentation. In general, we must include the requirements, specifications, risks, and verification and validation activities.

Section 17: Cybersecurity / Interoperability

Submission of applicable information regarding the assessment of cybersecurity/Interoperability, if applicable.

 Section 18: Electromagnetic Compatibility (EMC) and Electrical Safety

You must evaluate the EMC of a device’s electrically powered components. Irrespective of whether any electrical component is in patient contact or not, they should not be a threat to patient safety. The electrical safety document should prove that the electrical components in patient contact are safe for use.

Section 19: Performance Testing

Finally, these sections are dedicated to your device’s performance documents. You must compare your device’s performance characteristics to the predicate device and include all the proof for comparison, as done in Section 9. Please note that only the first section is mandatory; the other two sections are optional. However, irrespective of the sections you work upon, you need to consider the following two aspects:

• All the completed tests must have results and summaries, protocol descriptions, methodologies, how you analyzed it, clear and concise results, and a conclusion.
• Every protocol must mention the test objective, number of devices, study endpoint, and pass/fail criteria.

 Section 20: References

Inclusion of any literature references, if applicable.

 Section 21: Administrative Documentation

Inclusion of additional administrative forms applicable to the submission, including but not limited to a general summary of submission/executive summary (recommended), a Truthful and Accuracy Statement, and a 510(k) Summary or statement.

Where Can You Go Wrong with Your FDA 510(k) Submission?

Though you undertake a huge task of preparing all the required documentation, there are chances of missing out on vital information if you are not organized. Yes, a lot can go wrong with 510(k) submission; in fact, 75% of 510(k)s are rejected by the US FDA. From missing out on the right files in the right format to not having the right 510(k) predicate(s), there are many reasons for the rejections. Some of the reasons are:

• Following the wrong submission format.
• The documentation is inadequate.
• Not Demonstrating Equivalence with Predicates
• There is a lack of testing data.
• There are discrepancies in the indications of use.
• There are no records of validation testing.

How Do You Get Your FDA 510(k) Submission Right on the First Go?

Here are a few best practices you can adopt:

• Read and follow the guidelines accurately.
• Develop the right Regulatory strategy.
• Follow the US FDA’s checklist.
• Submit the right formats.
• Partner with the right Regulatory partner.
• Review the existing regulations.
• Structure your testing summaries.
• Prove the SE.
• Utilize design and document control tools.

Where Should You Start?

All said and done, the US FDA’s 510(k) submission process or the FDA 510(k) clearance process can be complex and challenging if you are not familiar with the requirements in detail. But come what may, gaining the US FDA’s clearance is crucial for your medical device’s market success.

Experience the right-first-time market success for your medical device. Reach out to our Regulatory experts to witness time-tested best practices at each step of your 510(k) medical device approval process /the FDA 510(k) submission process and obtain market clearance without delay.