Quality in 510(k) “Quik” Review Program Pilot
The FDA gave a very informative webinar about the new Quality in 510(k) review program pilot. The Quik Review began on September 6, 2018 as an effort by the FDA to simplify and increase 510(k) review process of certain “well established and understood” 510(k) devices.
The differences between the current review and Quik program are there is no refuse to accept review (however the FDA may place the file on hold if the sections are not complete), the review will be interactive through email or phone and the FDA will have a decision by day 60. The FDA may still place the review on hold if the sections are not complete or if additional information is requested. If the reviewer finds the submission to have complies issues such as requiring clinical data or additional testing the submission will be converted to the 90-day review process. This decision will be communicated to the applicant by email upon determination with an explanation as to why the submission is ineligible for the Quik Review Program.
The benefits of the program are ones that I think all regulatory professionals will appreciate. The review time is shorter, no hard copy is required, upfront knowledge of what is expected in a 510(k) submission, the format is standardized and “compliments the reviewer’s smart template promoting a more efficient review”, and no “refuse to accept” review. All of which will surely make submission a lot less stressful.
To be eligible for a Quik submission your 510(k) can only be traditional or abbreviated, use a primary product code from the pre-identified list, use the eSubmitter template and CDRH must be the lead Center. If you do not meet these criteria your submission will be required to comply with the eCopy requirements and will be reviewed by the normal 510(k) review process. Special 510(k)’s and combination products are not included in the program.
The Quik review submission content is the same as the normal review process however the Truthful and Accurate statement will use electronic signatures.
The Quik Program Pilot utilizes the eSubmitter software to provide a standard submission template, format, package and validate the submission. However, the eSubmitter does not submit the 510(k) to the FDA. A brief overview of the eSubmitter software seems to be user friendly and was said to be like Turbo Tax. By selecting certain icons on the tool bar, you will be notified if a page is complete by seeing a check mark, or incomplete by a viable question mark. Blue dots indicate the questions are required to be completed and yellow light bulbs provide helpful hints for most of the questions in the template. The FDA said the structure section of the eCopy guidance doesn’t apply to the Quik Program Pilot. One thing to keep in mind this is not part of the Electronic Submission Gateway (ESG) so don’t get confused.
The only hard copy that must be included in the submission is the cover letter. It must have the following statement:
“This submission is part of the Quik Review Program Pilot, and is organized according to the standard eSubmitter output package. Accordingly, special eCopy processing applies. As per the agreement for the Quick Review Program Pilot, no full paper copies are required.”
During the program the FDA will collect and assess the following data:
Total submission received
Product codes
510(k) number
Total Time to Decision
If a submission was found ineligible:
The reason
The FDA Day on which it was concurred upon as ineligible
The FDA Day it was placed on hold
Once the FDA has enough data they will decide on if the Quik Program will become permanent. They anticipate that the pilot will last at least to the end of 2018. The FDA said they will take suggestions for more product codes from industry but the ones that the review group selected are codes that are well understood based on their experience and are able to be reviewed within the 60-day time frame.
As usual at the end of the webinar the FDA opened the floor to questions. There were many great questions asked such as:
How long the program would last? (at least until the end of the year)
Where can we find the product codes? (on the pilot web page),
Can you have a secondary product code? (yes but if it adds to the complexity of the submission it may transition to the 90-day review),
How do you submit clinical data? (you can submit data in excel or convert it to a pdf and package the data into the .zip files in a miscellaneous files folder),
What do we do if a mistake is made in the submission? ( you can email the reviewer and inform them of the change and attach the docs effected by the change to the email),
Do you have to register to be part of the pilot? (no),
If you are converted to a 90 day submission will this require a new 510(k)? (no),
Will the FDA give notice when the pilot will end? (yes, the FDA will give sufficient notice),
If you have corrected deficiencies can you re-submit through the Quik Program? (yes as long as you meet the criteria. You will have to include the new information in the section called related Submissions).
Over all I think the program will be a win-win for both the FDA and industry by making the 510(k) process less stressful and allow industry to get product to market faster. We will all have to keep our fingers crossed.