The most common way to answer this question is with a question.

How long is a review supposed to take? or
How long does a review actually take?

Most people want to know the answer to the second question, and they want real data to back it up. Therefore, last month I performed a data analysis of 510(k) review timelines and presented this information in a webinar on 510(k) lessons learned. This will also be published a new blog this week: http://medicaldeviceacademy.com/blog/

The FDA has targets for how long it should take to make a decision: 90 days for a traditional 510(k) submission, 60 days for an abbreviated 510(k) submission and 30 days for a special 510(k) submission. The beginning of the process is the same for all three types of submissions. First, the FDA Document Center receives your hardcopy and ecopy for the submission. The ecopy is typically uploaded immediately upon receipt and you will receive an automated acknowledgement letter for receipt–including the 510(k) number that has been assigned. The FDA’s goal is to process the submission within 7 days, but typically you will receive the acknowledgement letter within hours of receipt.

The second step of the process is the “Refusal to Accept” (RTA) review process:

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf

The RTA review process involves a preliminary reviewer filling out a long checklist to ensure that your 510(k) submission includes all the required elements of a submission. Sometimes you will receive a communication that something is missing and if you respond immediately you can avoid an RTA Hold Letter, but typically you will receive either an acceptance letter within 15 days or an RTA Hold Letter within 15 days. If you receive an RTA Hold Letter you must address the problems and resubmit to the FDA. When the replacement ecopy submission is provided to address an RTA Hold Letter then “clock” starts back at 0 days. If your submission is accepted the clock continues to count toward the FDA target of 90, 60 or 30 days.

Once your submission is accepted you are in the substantive review portion of the review timeline. At any time during the next 60, 45 or 15 days you could receive a request for additional information. If you receive a request for additional information, then the clock is stopped and you have up to 180 days to respond. If you fail to respond, your submission will be automatically deleted on the 181st day and you will need to resubmit your 510(k) and pay your fee again if you wish to continue to the process.

The time required to respond to questions from the FDA reviewer is what creates the discrepancy between the decision days the FDA is reporting and the actual time you experience. I have heard many different estimates of how long the actual time is for the FDA to reach a decision, but the best approach is to measure the most recent submissions. Below are the findings from my own data analysis:

690 Submissions to General & Plastic Surgery Panel between January 1, 2015 and August 10, 2016.

Shortest Review = 8 days
Longest Review = 646 days

Average Traditional Review (576 submissions) = 183 days
Average Abbreviated Review (7 submissions) = 166 days
Average Special Review (107 submissions) = 53 days

I will be sharing additional information and graphs in my blog, but the greatest success factor in obtaining shorter reviews is being able to provide all the data the FDA wants in the initial submission or upon request. There are four sources of information that tell you what information the FDA will request.

1. FDA guidance for 510(k) content (general information)
2. Standards and Guidances listed for each classification code (class-specific information)
3. Predicate 510(k) summaries (summary of device-specific information)
4. Predicate 510(k) submissions (complete device-specific information)

source: https://www.linkedin.com/groups/2070960/2070960-6173467726086959108