refuse to accept

Why RTA (Refuse to Accept)?

The FDA conducts an acceptance review of a 510(k) submission (Traditional 510(k), Abbreviated 510(k), or Special 510(k)) against acceptance criteria to identify if the submission is complete or not. This acceptance review is known as the RTA review and it aids the reviewer in identifying the location of the document corresponding to each element in a 510(k) submission and allows to evaluate if the submission is ready to be taken to the next step of review (substantive review).

When does the RTA (Refuse to Accept) process begin?

The RTA acceptance review process begins when a 510(k) is submitted with a valid e-copy indicating the user fee has been paid.

When is the RTA review performed?

This review is performed within 15 days of the receipt of submission. The RTA acceptance review is performed only upon receiving an initial submission and shall not be performed for other kinds of responses, supplements, or amendments once the submission has passed through the RTA review stage.

When does a submission receive an RTA designation?

A submission will receive an RTA designation if any of the RTA items per the RTA criteria is not available or a justification provided for the same is not acceptable.

What are the important elements of a 510(k) RTA (Refuse to Accept)?

The following are the most important elements of the RTA. Information corresponding to each of the following must be included in a 510(k) submission. Even though it is clear the kind of information that has to be submitted, but is very important to know the extent of information to be submitted.

⦿ Administrative information
⦿ Device description
⦿ Substantial Equivalence
⦿ Proposed labeling
⦿ Sterilization
⦿ Shelf life
⦿ Biocompatibility
⦿ Software
⦿ Cybersecurity
⦿ EMC
⦿ Electrical Safety
⦿ Performance data and characteristics

Interactive Review and RTA:

The FDA reviewer is expected to verify if any omitted item is required or not and is expected to conduct an interactive review with the submitter if deemed necessary, requesting information. FDA also evaluates if the time is adequate for the submitter to share requested information and for the reviewers to verify the information within 15 days, which is the due acceptance date.

Notification on an RTA hold:

If the submission is not accepted, the reviewer will notify the submitter electronically and share a complete report that identifies the missing items, thereby providing a justification behind the RTA hold.

Response to an RTA hold:

The submitter is free to share a response along with the missing information with the FDA under the same 510(k) number; this does not require further payment or resubmission.

What happens when an RTA hold response is delayed?

FDA withdraws or closes the 510(k) submission if a response to the RTA notification is not provided within 180 days of the RTA hold notification date.

Notification of RTA (Refuse to Accept) Acceptance:

Once the submission is accepted, the reviewer notifies the submitter that it has been accepted and this means the submission will now go under substantive review. If the review is not completed in 15 days, the submitter is notified that the review is not complete and is under substantive review.

Review Clock

For various types of 510(k) submissions, there is a corresponding review clock. A typical 510(k) submission is reviewed as per the following timeline (based on the FDA guidelines).

The image above clearly depicts the various stages involved in the review of a 510(k) submission. All the days mentioned are the FDA days. This review flowchart does not include the time taken by the submitter to submit a response to any of the questions or comments sent by the FDA during an e-copy hold, RTA hold, etc.

Beware!

A submission that is written by including all the important elements and by providing the right extent of information shall not undergo an RTA hold.

While an RTA hold may seem to be an innocent mistake, it can have serious repercussions for the applicant depending on the reasons for receiving an RTA hold.

Due to the RTA hold, often many companies may lose the credibility, respect, and positive impression that they should be working towards building from the beginning of a 510(k) submission.

In certain instances, it has been observed that a company receives multiple RTA holds, this has a severe impact on the overall product launch timeline and can create internal and external dissatisfaction and frustration.

The best approach is to clearly know all the elements of an RTA, comprehensively provide the right information to the extent needed, and understand which elements apply and which do not and why? Small steps taken today can save one a lot of time, money, and resources.

Having done numerous 510(k)s, Elexes has been reviewing submissions on an ongoing basis to suggest if they would get through an RTA or not. For any questions or comments please feel free to reach out to us at jennifer@elexes.com to assist you in filling the RTA checklist for Traditional, Abbreviated, and Special 510(k).

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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