510 (k) Submission for Quick FDA Clearance: 13 Mistakes to Avoid from Samradni Patil, freelance regulatory writer on Kolabtree.
The 510(k) submission process is used typically for Class II devices to obtain clearance from the US Food and Drug Administration (FDA). The 510(k) review process determines Substantial Equivalence (SE) with the predicate device. The device needs to be at least as safe and effective as the predicate device to claim SE with the predicate device.
510(k) Submission Checklist Process
Here’s a 510(k) submission checklist to help you prepare a strong application.
Refuse to Accept (RTA) letter
The purpose of the acceptance review at the initial stage is to check if the 510(k) application is administratively complete. Review the acceptance checklist provided in the guidance document “Refuse to Accept Policy for 510(k)s”.
Inadequate Device Description
Device description is mandatory in 510(k) applications. Add a brief description and technical specifications in this section. All device models, accessories, pictures, diagrams, dimensions, drawings, and tolerances for each component should be included. Inappropriate technical specifications may lead to misconceptions and requests for additional testing.
Inconsistent Information throughout the Submission
- Inconsistency in Device Description: If a company decides to do 510(k) submission to add an additional model, it is important that applicable sections such as cover letter, device description, labeling, substantial equivalence discussion, performance-related sections are aligned with actual change. Inconsistency may lead to administrative delays and in the worst-case request for additional testing.
- Inconsistency in Indication for Use: Similar to device description, inconsistency in indication for use in various sections of the 510(k) may cause issues. Indication for use statements is very important to make SE determination.
Different Intended Use than the Predicate Device
To get SE determination from the FDA, the device needs to have the same intended use as the predicate device. This is important because different intended use than the predicate device may lead to different safety and efficacy issues. In such cases, 510(k) may not be an appropriate pathway to get product clearance. It should be noted that differences in the indication for use between the predicate device and the device under 510(k) review may not necessarily result in the different intended use. Companies should put additional efforts to clearly show that differences in the indication for use have not resulted in the different intended use.
The FDA guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” should be referred to get clarity on the intended use-related questions.
Inadequate/Missing Testing Information
Based on the type of device electrical safety testing, electromagnetic compatibility (EMC) testing, biocompatibility testing, software validation testing, sterilization testing, usability testing may be required to claim the safety and efficacy of a device. It is important to understand the difference between Traditional 510(k) and Special 510(k). All testing data must be included in the Traditional 510(k) submission.
Failure to Follow Current Guidance Document(s)
As discussed above, ensure that testing is conducted to show compliance with the latest recognized standards. There may be significant changes in the latest version of the standard compared to the previous version. This may result in additional questions about safety and efficacy if the device is not tested with the latest version of the standard. Refer to the latest guidance documents to understand FDA’s expectations.
The ultimate goal of the 510(k) process is to determine Substantial Equivalence (SE) with a predicate device. When additional information is requested by the FDA during the substantive review phase, companies should carefully review each request and provide a scientifically sound response. Failure to provide requested data/ response may result in NSE determination. A lot of NSE determinations are due to a lack of providing performance data. It is highly recommended to consult and collaborate with FDA to understand expectations at this phase.
Submitting application at the correct address
This is an easily avoidable human error. Always refer to the FDA website for the correct address to submit your application.
Including hard copy as well as eCopy
The FDA has specific requirements for the number of hard copies and eCopy that need to be submitted for 510(k) application. Currently,1 hard copy and 1 eCopy is required. Don’t make any assumptions. Refer to the FDA website before jumping to any conclusion.
eCopy related issues
The submission must meet eCopy technical standards. Refer to the eCopy guidance to prepare eCopy of the application. PDF naming convention and file size recommendation must be followed to avoid eCopy hold letters. Though the use of the eSubmitter-eCopies tool is voluntary, this tool helps to validate eCopy as per FDA recommendations.
Submitting information to the reviewer
After receiving the initial hold letter from FDA (RTA hold, eCopy hold), companies often make a mistake while submitting information to the reviewer. Check the email received from the FDA or appropriate guidance from the FDA about where to send a response to the hold letter.
Traditional 510(k) vs Special 510(k)
Companies can make a mistake categorizing an application as Traditional 510(k) or Special 510(k). The major difference between Traditional 510(k) and Special 510(k) is the time required to review an application by the FDA. Special 510(k) takes 30 calendar days while Traditional 510(k) takes 90 calendar days. If you are in doubt, take help from FDA submission consultants or freelance regulatory writers.
Nature of the device
Some devices may raise unique questions due to the unique nature of the device. Certain technological areas such as Artificial Intelligence (AI) and Cybersecurity are relatively new. FDA has collaborated with the industry to develop guidance documents in these areas.
In such cases, a prior meeting with the FDA before 510(k) submission is highly recommended. Refer to the FDA guidance document if companies need feedback and meeting with FDA before 510(k) submission.
Need help from an FDA submission consultant? Work with experienced regulatory writers and 510(k) consultants who’ve helped companies prepare regulatory documents for successful FDA clearance.
Author bio: Samradni Patil is an accomplished pharmaceutical and medical device regulatory and quality professional with over 12 years of experience in regulatory compliance, product development, chemistry, and post-market compliance. She provides consulting services on Kolabtree. Her specialties include 510(k) submission, Health Canada product registration, CE mark, audits, and more.