Jesseca Lyons, Customer Success Expert, greenlight.guru09.15.16
By the time you get done designing, developing, and testing your new medical device, you’ve spent countless hours creating documentation. Now it’s time to begin compiling it all together to submit to the FDA. It’s easy to have read through everything so many times that you start to overlook the small details. Following are three factors you should double check before submitting your 510(k) to give your submission the best chance at being accepted the first time.
1. Check the Indications for Use
It might seem obvious, but one of the first things to double check is that your indications for use is consistent throughout the entire 510(k) submission. There are at least six different locations in the submission that include the indications for use. Yes, you read that correctly—not one or two, but six different locations that have you restating the same thing.
What’s so difficult about it being in all of these different locations?
For starters, the initial indications for use is likely going to be revised several times. That means by the time you’re done filling out the CDRH Premarket Review Submission Cover Sheet, there’s a really good chance that the indications for use you put there isn’t going to match what you had put in your instructions for use (IFU), which is part of the proposed labeling section.
It’s very easy to lose track of which sections you’ve updated and which ones you haven’t when a change is made for the umpteenth time. If you submit with discrepancies in the indications for use, you’re going to hear back from the FDA.
Pro Tip #1: Before you submit, take a final version of your indications for use and copy/paste it into the appropriate sections to ensure it’s consistent.
2. Check the Page Numbers/Table of Contents
In high school, I had an English teacher who would refuse to accept papers if they weren’t formatted according to the MLA guidelines. Not familiar with the acronym? That’s the Modern Language Association (MLA) and they published a guidebook for how papers should be formatted, how citations should be documented, etc. We were told how to format everything from the size of the margins to the indentation appropriate for quotes.
Luckily, the FDA isn’t that strict with the guidelines on how the 510(k) should be organized, but they do have some suggestions. There’s a small section at the beginning of the RTA (refuse to accept) checklist that covers organization of the submission. Does it have a table of contents? Are the sections labeled? Are the pages numbered? These are all really minor things, but it will help you out in the long run.
How do they help you?
The table of contents is a final checklist to make sure you included all of the sections; labeling the sections helps you find them as you’re organizing them. The most important to you—page numbers. Page numbers are referenced by the reviewer when they come back with questions. If you’ve got all of your pages numbered correctly, it’s going to make their job (and your life) a lot easier.
Pro Tip #2: Before you submit, use your table of contents to check that you’ve included all of the sections in the correct order. Then go through the page numbers again to make sure you haven’t missed anything.
3. Check Off the RTA Checklist
Once all of your sections are in the correct order, print off a copy of the RTA checklist. At this point, you likely have your submission memorized and if asked a question, can quickly flip to the exact page needed. Unfortunately, the reviewer has not been eating, breathing, and sleeping your device for the past few years (or months if you worked really quickly). It’s going to take them time to go through everything.
One way to help them out is to go through the same checklist they will be using and write down the page numbers where the information can be found. Put a copy of the checklist at the beginning of the submission and keep one for yourself. If the reviewer comes back saying something is missing, you can go scan the checklist and, hopefully, just give them the page numbers instead of needing to send in more documentation.
Pro Tip #3: Before you submit, pretend you’re the reviewer and go through and fill out the RTA checklist. Better yet, have someone else do it so they can act as an independent reviewer.
Putting It All Together
At the end of the day, when you’ve submitted your 510(k), the whole goal is to make it through to the other side—successfully. The first hurdle to clear is the RTA review. It is possible to make it through that review period without the FDA asking you for a single additional thing. If you went back and double checked these three things, there’s a good chance your submission will be one of those that does.
Bonus Pro Tip: If you’d like to learn more specific tips and best practices directly from a former FDA reviewer that you can implement at your medical device company to improve your 510(k) submission process, check out this free webinar on the topic.
Jesseca Lyons is a customer success expert at greenlight.guru (quality management software exclusively for medical device companies) and a mechanical engineer by trade who loves working with cross-functional teams, including both engineering and non-engineering disciplines. She’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. Lyons believes the best part of being an engineer and working at greenlight.guru is that she can use her skills to help customers and make a positive impact in their lives.
1. Check the Indications for Use
It might seem obvious, but one of the first things to double check is that your indications for use is consistent throughout the entire 510(k) submission. There are at least six different locations in the submission that include the indications for use. Yes, you read that correctly—not one or two, but six different locations that have you restating the same thing.
What’s so difficult about it being in all of these different locations?
For starters, the initial indications for use is likely going to be revised several times. That means by the time you’re done filling out the CDRH Premarket Review Submission Cover Sheet, there’s a really good chance that the indications for use you put there isn’t going to match what you had put in your instructions for use (IFU), which is part of the proposed labeling section.
It’s very easy to lose track of which sections you’ve updated and which ones you haven’t when a change is made for the umpteenth time. If you submit with discrepancies in the indications for use, you’re going to hear back from the FDA.
Pro Tip #1: Before you submit, take a final version of your indications for use and copy/paste it into the appropriate sections to ensure it’s consistent.
2. Check the Page Numbers/Table of Contents
In high school, I had an English teacher who would refuse to accept papers if they weren’t formatted according to the MLA guidelines. Not familiar with the acronym? That’s the Modern Language Association (MLA) and they published a guidebook for how papers should be formatted, how citations should be documented, etc. We were told how to format everything from the size of the margins to the indentation appropriate for quotes.
Luckily, the FDA isn’t that strict with the guidelines on how the 510(k) should be organized, but they do have some suggestions. There’s a small section at the beginning of the RTA (refuse to accept) checklist that covers organization of the submission. Does it have a table of contents? Are the sections labeled? Are the pages numbered? These are all really minor things, but it will help you out in the long run.
How do they help you?
The table of contents is a final checklist to make sure you included all of the sections; labeling the sections helps you find them as you’re organizing them. The most important to you—page numbers. Page numbers are referenced by the reviewer when they come back with questions. If you’ve got all of your pages numbered correctly, it’s going to make their job (and your life) a lot easier.
Pro Tip #2: Before you submit, use your table of contents to check that you’ve included all of the sections in the correct order. Then go through the page numbers again to make sure you haven’t missed anything.
3. Check Off the RTA Checklist
Once all of your sections are in the correct order, print off a copy of the RTA checklist. At this point, you likely have your submission memorized and if asked a question, can quickly flip to the exact page needed. Unfortunately, the reviewer has not been eating, breathing, and sleeping your device for the past few years (or months if you worked really quickly). It’s going to take them time to go through everything.
One way to help them out is to go through the same checklist they will be using and write down the page numbers where the information can be found. Put a copy of the checklist at the beginning of the submission and keep one for yourself. If the reviewer comes back saying something is missing, you can go scan the checklist and, hopefully, just give them the page numbers instead of needing to send in more documentation.
Pro Tip #3: Before you submit, pretend you’re the reviewer and go through and fill out the RTA checklist. Better yet, have someone else do it so they can act as an independent reviewer.
Putting It All Together
At the end of the day, when you’ve submitted your 510(k), the whole goal is to make it through to the other side—successfully. The first hurdle to clear is the RTA review. It is possible to make it through that review period without the FDA asking you for a single additional thing. If you went back and double checked these three things, there’s a good chance your submission will be one of those that does.
Bonus Pro Tip: If you’d like to learn more specific tips and best practices directly from a former FDA reviewer that you can implement at your medical device company to improve your 510(k) submission process, check out this free webinar on the topic.
Jesseca Lyons is a customer success expert at greenlight.guru (quality management software exclusively for medical device companies) and a mechanical engineer by trade who loves working with cross-functional teams, including both engineering and non-engineering disciplines. She’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. Lyons believes the best part of being an engineer and working at greenlight.guru is that she can use her skills to help customers and make a positive impact in their lives.
