There are going to be several sections of your 510(k) submission that are going to revolve around forms or templates that you get directly from the FDA. The first two sections of your 510(k) submission consist entirely of FDA forms for you to complete.

Section 1.0 is the Medical Device User Fee Cover Sheet (FDA Form 3601) and Section 2.0 is the CDRH Premarket Review Submission Cover Sheet (FDA Form 3514).

Seems pretty straightforward right? There are a couple of things that you'll need to keep in mind.

First and foremost – make sure you're using the current revision of the form. If you're preparing several 510(k) submissions, you're going to want to save yourself time and download a copy of the form. Just make sure that before you go to use it, that it's still current.

Second – make sure you're using Internet Explorer and have the latest version of Adobe Acrobat. The Medical Device User Fee Cover Sheet is now actually only available online. You will need to register with the FDA to be able to view it.

In all reality, it's just a receipt of payment. It has basic information and type of submission. All you need to do is include a copy of it as section 1.0 in your submission.

The CDRH Premarket Review Submission Cover Sheet is a little more involved. It's about 5 pages long and contains nine sections. The first few sections (sections A – D) are straightforward. It's basic information about the type of submission, reason for submission, and applicant.

It can start to get a little more complicated after that. When you get to Sections E and F, take a few moments to read and re-read the form. Section E is asking about the PREDICATE device. Section F is asking about your device.

The big problem? The two sections run together. There is a black line separating them, but there's no white space to help you out. It's not uncommon for people to put the predicate device name in section F instead of their product name.

And finally, a reminder to check that the indications for use statement on the form matches the indications for use statement used in the rest of the submission. This is one of the biggest reasons FDA rejects 510(k) submissions.

Go ahead and create a folder on your computer to start organizing everything now. Take those forms and put them in folders labeled section 1.0 and section 2.0. It's also a good idea to go ahead and create the cover sheets for those sections now too.

Section 3.0 is exactly what it sounds like: a cover letter with some basic administration information, the basis for the submission, and a table supplying information on the design and use of the device. It should be kept fairly straightforward and to the point.

Do be sure your cover letter includes all of the following:

• Type of 510(k) submission, Abbreviated or Traditional
• Your device type in plain terms, i.e., by its common name
• 510(k) submitter
• At least one contact person, by name, title, and phone number
• Your preference for continued confidentiality (21 CFR 807.95)
• Your recommended classification regulation
• Class (i.e., whether it is unclassified or a class I, II, or III device)
• Review panel
• FDA product code
• Any FDA document numbers associated with prior formal correspondence with FDA (e.g., IDE, pre-IDE, 510(k), PMA, request for designation (RFD)) related to your device.

Section 4.0 – Indications for Use statement (FDA Form 3881) and Section 5.0 – 510(k) Summary are what you will find if you go searching the 510(k) database. That means the summary document you created will be out there for everyone to see.

Per CFR 21 Part 807.95(d): "FDA will make a 510(k) summary of the safety and effectiveness data available to the public within 30 days of the issuance of a determination that the device is substantially equivalent to another device."

Things can start to get a little trickier in Section 4.0 – Indications for Use Statement. The tricky part is in the actual content of your indications for use statement. This is a key component of your submission. You have to prove substantial equivalence of the indications for use between your device and the predicate device.

If you get more specific, you may raise questions on safety and efficacy of the new device and need to conduct additional testing. Or you may get told by the FDA to change your indications for use…or even to pick a new predicate device. Either way, it can mean a longer time to market.

The whole goal of this section is to be a summary of the rest of your submission and includes information from the cover letter as well as a summary of the substantial equivalence comparison and of the testing that was performed. Remember: FDA makes this summary public within 30 days of the decision.

Now that we've gotten all of the introductory pieces out of the way, there are four templated sections to get through before getting into all the details of your proposed medical device. These sections are going to be fairly straightforward.

Section 6.0 – Truthful and Accuracy Statement is exactly what it sounds like. It's a statement that certifies that all of the information included is truthful and accurate and that nothing has been omitted. The FDA has provided you with the exact content of the statement.

Section 7.0 – Class III Summary and Certification — if your device is class II, the section is going to consist of a single sentence: "This device is not a class III device." If your device type is a class III but does not require a PMA, you'll need to provide a summary of the types and causes of safety/effectiveness problems.

Section 8.0 – Financial Certification or Disclosure Statement — if you didn't perform any clinical studies, you can simply state: "No clinical studies were performed to test this device." There are two forms: the Financial Certification (if investigators were not paid beyond study costs) and the Disclosure Statement (if they were paid).

It's important to remember that your submission looks like an incomplete submission without these sections, even when not applicable. Always include a statement explaining why they are not applicable.

At this point, you've made it halfway through your 510(k) submission. The last half is going to go one of two ways – easy or hard. Have you kept up with design controls documentation, risk management documentation, and establishing a quality management system? If so, it's going to be a whole lot easier.

The second half starts with an Executive Summary describing your medical device, comparing it to the predicate device, and summarizing all of the testing you've done. Unlike the 510(k) summary in Section 5.0, the Executive Summary is not released on the internet, so you can include more detail.

Section 11.0 – Device Description is not just a brief description. From your design outputs, grab the detailed drawings (complete with dimensions and tolerances) for each device, accessory, and component. List any components in patient contact and include material specifications.

Section 12.0 – Substantial Equivalence Discussion — go step by step through the devices and show how the indications for use, technology, and performance are the same or equivalent. Create an easy-to-read table that specifically calls out indications for use, technology, and performance. Keep it short and to the point.

Section 13.0 – Proposed Labeling will be pulled straight from your design outputs. Grab a copy of your device label, instructions for use (IFU), package insert, and any patient labeling. Note that the FDA also considers information on your website about your product as labeling. Remember: you are not allowed to market your device prior to receiving 510(k) clearance.

Keep in mind: if a section isn't applicable to your device, don't skip it — include the section with a brief explanation. When presenting test results, always include both the protocol and the report.

Section 14.0 – Sterilization and Shelf Life — if your device is non-sterile, very clearly state that. If you plan to make a shelf-life claim, support it with applicable product testing, often including accelerated age testing.

Section 15.0 – Biocompatibility — if you've got anything in direct or indirect patient contact, this section is critical. The FDA RTA checklist clearly states you need to include the protocol and reports. The only exception is if your device is identical in both material and manufacturing to the predicate device.

If your device doesn't have any software or electrical components, these sections will consist of one sentence: "My medical device does not have software/electrical components, this section is not applicable."

Section 16.0 – Software starts with the level of concern and your rationale. The rest covers requirements, specifications, risks, and verification and validation activities. The higher the level of concern, the more documentation you'll need. IEC 62304 is recognized by the FDA and provides an excellent framework for the entire medical device software lifecycle.

Section 17.0 – Electromagnetic Compatibility and Electrical Safety — you need to evaluate your device's electromagnetic compatibility (EMC) regardless of whether electrical components are in patient contact. The recognized standard is IEC 60601-1-2. If electrically powered components are in patient contact, you also need to comply with IEC 60601-1.

You're in the home stretch. Part of proving substantial equivalence is comparing the performance characteristics of your device to the predicate device. Not all of these sections are mandatory.

For any section, keep these general principles in mind:

• Each section should have a description of the protocol, a summary of results, how you analyzed it, and the conclusion.
• The protocol needs to spell out the objective, sample size, test method, study endpoint, and pass/fail criteria.
• Results should be clearly and concisely stated.
• Do not include raw test data in the middle of the report — put it in an appendix.

Section 18.0 – Bench Testing will likely contain the majority of your design verification and validation testing.

Sections 19.0 & 20.0 – Animal and Clinical Testing may not be applicable to your submission. You are not obligated to do animal and clinical testing. If you need guidance, use the pre-submission process (Q-Sub) or applicable guidance documents. If clinical testing is necessary, determine if your study is significant or non-significant risk. Significant risk studies require compliance with IDE regulations in 21 CFR Part 812.

The very last thing you should do before you submit your 510(k) is grab the RTA checklist. Go through it and write down the page numbers where everything can be found. If you notice anything is missing, this gives you the chance to add it.

Reference: www.greenlight.guru