Essential Tips for New FDA 510(k) Refuse to Accept Policy
May 12th, 2013 // 10:50 pm @ jmpickett
Latest FDA and cGMP Compliance News
FDA recently revised its Refuse to Accept policy for all 510(k) applications that did not have all required documentation. All device manufacturers that want to go through the premarket notification process should get to know all of the steps that are need to get their 510(k) application done and on the right track, just in case they get an RTA notice from the agency.
The new RTA process is in effect as of 2013 and it includes an early review of all applications to see if they are complete administratively and to see if they have all materials needed for FDA to do an adequate review. The RTA screening will go before the full premarket notification that decides if a device gets the 510(k) clearance or not.
The RTA review process by FDA includes these steps:
- When a 510(k) is turned into FDA, the agency has fifteen days to make the decision of whether they should accept the submission and if the app is administratively complete.
- The RTA review by FDA will deal with all traditional, special and abbreviated apps. It will use the Acceptance Checklist that is found on page fifteen. of the RTA guidance by FDA, which is from December 2012. If anything on the checklist is not on the application, FDA will tell the applicant by mail which of the items are not there.
- The applicant can answer the RTA notice from FDA by giving the agency any information that is missing.
Keep in mind that missing information should be put in the file that is in the original 510(k) number. Also, a new submission/user fee are not needed for you to give the information that is missing. You can submit only the information that is being asked for in the RTA notice.
You have 180 days to answer the RTA notice from FDA. If you do not respond within 180 days, FDA assumes the 510(k) was withdrawn.
Once you have turned in the missing information, another review will be done by FDA to determine if the submission is complete. If the 510(k) is accepted to be reviewed, FDA will notify you.
Keep in mind that medical device firms could have a delayed path to the marketplace if they do not follow FDA’s new RTA policy. It is very important in the future that any FDA 510(k) applicant takes all of the steps at the beginning of the process of registration to make sure the submission is totally accurate and complete.
