Posted: 03 Jan 2016 07:38 PM PST
By Allyson B. Mullen –
In August, CDRH quietly implemented a new version of the 510(k) Refuse to Accept (RTA) Policy in a draft guidance, titled "Refuse to Accept Policy for 510(k)s" (New RTA Guidance). This change was done with so little fanfare that many did not even notice – we did not even blog on it. We recently realized, however, that the new RTA policy warranted discussion, and FDA should be commended for the changes it instituted.
You may recall that we previously blogged on some of the foolish RTA comments we saw in CDRH’s first year of implementing the 510(k) RTA policy. The changes made to the 510(k) RTA policy appear to try to curb some of these mindless RTA comments by giving “FDA staff . . . discretion to determine whether missing checklist items are needed to ensure that the submission is administratively complete to allow the submission to be accepted.” New RTA Guidance at 7. Reviewers are also now permitted to “request missing checklist items interactively from submitters during the RTA review.” Id. We read this as allowing reviewers to request outstanding items from submitters without formally refusing the submission. While we have yet to see such interactive review employed by reviewers, permitting such flexibility is positive compared to rigid application of a checklist.
CDRH also implemented several changes to the checklists to address this new discretionary, “common sense” approach. Some of these examples are seen in the Traditional 510(k) RTA Checklist and include:
A few other changes of note in the Traditional 510(k) Checklist include:
Se consigue revertir una lesión medular con terapia génica Prueban con éxito en un modelo experimental una terapia génica que regenera lesiones medulares completas y revierte la parálisisSe consigue revertir una lesión medular con terapia génica Prueban con éxito en un modelo experimental una terapia génica que regenera lesiones medulares completas y revierte la parálisis
Hace 4 horas