mdi ConsultantsClients are being made aware of an important development from the FDA with regards to the 510(k) submission process. A revised version of the guidance document “Refuse to Accept Policy for 510(k)’s” will go into effect October 1st, 2015. FDA revised this guidance with the purpose of describing the 510(k) Refuse to Accept (RTA) process in order to encourage administratively complete submissions and outline the information FDA believes is necessary to conduct a substantive review when making a substantial equivalence determination.
A summary of the changes to be expected due to this revision are:
Guidance Document:
- Clarify text to reflect checklist and RTA process modifications
- Removal of language that had the potential to lead to substantive review
- Update to references, guidance, and links changed since the prior checklist version
Checklists:
Streamline checklists to reflect practical review practice:
- Removal of criteria non-critical to initiate review (e.g., 510(k) Summary and 510(k) Statement contents, Standards Data Report Forms)
- Addition of options to permit reviewer discretion to accept files lacking certain non-critical information (e.g., software section permits discretion on applicability of content)
- Separation of elements better reviewed independently (e.g., electrical safety and EMC)
- Modifications to reflect changes in review policy (e.g., sterility section modified to reflect new reprocessing guidance)
Modification of checklist elements to improve clarity:
- Clarify text throughout checklist to improve understanding of information needed to address elements (e.g., information on prior submissions)
- Clarify text to remove language/elements that had the potential to lead to substantive review (e.g., removal of assessment of 510(k) Summary contents)
- Combine elements asking for similar information (e.g., substantial equivalence determination)
- Clarify/update elements per comments from FDA review staff and industry (e.g., addition of “N/A” boxes in Preliminary Questions section)
- Update to references, guidance, links changed since the prior checklist version
Improve Usability for Industry:
- Include page number column in checklist for industry to identify location of elements in submission
mdi Consultants Inc. has vast experience in the 510(k) submission process and has around 1800 successful FDA 510(k) clearances under its belt. RTA is now an integral part of this process and we have seen a lot of clients being stuck and on hold while getting through this initial step of the 510(k) process. mdi can help you to review, prepare, assess your 510(k) submissions in its entirety before they go to the FDA to make sure all the elements are met in a 510(k) submission so that they are not put on hold and reach the FDA in a timely manner.
To search for the newest revisions of the gfuidance document, click here: http://www.fda.gov/RegulatoryInformation/Guidances/ucm2005656.htm
?Email us at info@mdiconsultants.com if you have further questions about the RTA process. Ref: RTA Guidance