The Association for the Advancement of Medical Instrumentation (AAMI) has now published AAMI TIR102:2019, which maps the US Food and Drug Administration (FDA) Quality System Regulation (QSR, 21 CFR 820) to ISO 13485:2016 and vice versa.

The abstract for the Technical Information Report (TIR) reads: "This document provides a mapping of the US FDA 21 CFR requirements to the 'regulatory requirements' references in ISO 3485:2016. This mapping is intended to be a tool for US industry to help identify the regulatory requirements from the US medical device regulations to be addressed through an ISO 13485 quality management system."

The scope of the TIR reads:

"This document is a comparison of requirements between 21 CFR 820 and ANSI/AAMI/ISO 13485:2016 that demonstrates similarities, highlights differences, and discusses key considerations for medical device manufacturers. It is not a word-for-word literal identification of differences; thus, the reader must be familiar with quality management system requirements along with the statutory definitions to apply this report.

This document provides the basis for interpretation of the associated requirements and applicable U.S. FDA rules. Users must be aware that this analysis provides a comparison of the QS Regulation and the standard only. It is not inclusive of all global regulatory requirements applicable to medical device quality systems.

The comparison covers all parts of 21 CFR 820 including appropriate references to the Preamble to the QS Regulation and ANSI/AAMI/ISO 13485:2016. Other standards or parts of the U.S. regulations may be referenced but are not explicitly included in this report."

Copies of the TIR may be purchased from the AAMI website.

A final version of the draft document issued in October 2017 relating to US Food and Drug Administration (FDA) acceptance of de novo submissions has now been issued by the Agency. Titled 'Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff', 9 September 2019, it explains the procedures and criteria FDA intends to use in assessing whether a request for evaluation of automatic class III designation devices (De Novo classification request) meets a minimum threshold of acceptability and should be accepted for substantive review. Copies of the final guidance can be obtained from here.

To enhance consistency, the document provides FDA staff with a clear, consistent approach to making “Accept” or “Refuse to Accept” (RTA) decisions on De Novo requests. The guidance includes both an Acceptance Checklist (Appendix A. Acceptance Checklist for De Novo Classification Requests) as well as a Recommended Content Checklist (Appendix B. Recommended Content Checklist for De Novo Classification Requests), which applicants should use to ensure all elements are included in the submission, so as to avoid a 'RTA' response, which will require additional information to be submitted, with a consequential time delay in the start of the agency's substantive review process.

The De Novo requester may respond to a RTA notification by providing the missing information identified in the Acceptance Checklist. The De Novo requester should submit this information to the respective Center’s Document Control Center (DCC) to be included in the file under the originally assigned De Novo number. A new De Novo request and new user fee are not necessary, and it is not necessary to resend the entire De Novo request, unless FDA notes otherwise (e.g., because the De Novo request is missing the majority of the items on the checklist). It is sufficient to submit and address only the information requested per the Acceptance Checklist. If a response to the RTA notification is not received within 180 days of the date of RTA notification, FDA will consider the De Novo request to be withdrawn and the De Novo request will be closed in the system.  If FDA does not complete the acceptance review within the acceptance review period (i.e., within 15 calendar days of receipt), the De Novo requester should be electronically notified that the acceptance review was not completed and the De Novo request is now under substantive review.

The FDA review clock start date is the receipt date of the most recent De Novo request or additional information that resulted in an acceptance designation for the De Novo request, provided the user fee has been paid and a validated eCopy has been provided. The fee for a De Novo submission for financial year 2020 (which starts on 1 October 2019) is $102,299. The guidance document will apply from 30 October 2019.