On October 26, 2021, the US Food and Drug Administration (FDA) Centre for Devices and Radiological Health (CDRH) published the guidance document for fiscal year 2022 (FY2022) and the CDRH guidelines already issued in the past years on which wishes to receive any feedback to consider if reviewing or withdraw them.

USA list of CDRH guidelines published for fiscal year 2022
CDRH published the guidance document 2022

CDRH Guidance document for FY2022 are divided in the following 3 lists:

  • The A-list: list of Medical Device documents the FDA intends to publish during FY2022, such as Clinical Decision Supporting Software, Electronic Submission Template for Premarket Notification 510(k) Submissions, UDI, Remanufacturing of Medical Devices.
  • The B-list: list of documents serving as Guidance Resources in FY2022, such as Risk Categorization for Software as a Medical Device, Artificial Intelligence/Machine Learning (AI/ML), Enabled Device Software Functions, Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.
  • Retrospective review list: list of guidance documents issued in 1982, 1992, 2002, and 2012 that may be submitted to a possible revision according to feedbacks received.

You can consult the full list od guidance documents here: CDRH Proposed Guidances for Fiscal Year 2022 (FY2022).

Fiscal year 2022: have you renewed the Establishment Registration?

As each year FDA requires the Establishment Registration and Device Listing renewal as laid down by 21 CFR Part 807.

It is necessary to renew them for the following year (2022) at FDA no later than December 31, 2021.

The annual registration user fee for fiscal year 2022 is $ 5,672 for each establishment and there are no reduced fees or waivers. Therefore, each establishment has to pay registration fee and all Establishment Registration information must be submitted electronically.

Do you need help with Establishment Registration renewal?

Thema experts can support you in your activities and in carrying out formalities required by FDA for your renewal. Moreover, thanks to THEMA USA and to strategic partnerships, Thema also offers services such as U.S. Agent, U.S. Initial Importer and U.S. Electronic Medical Device Reporting.

Contact us for additional information!

Sources:

CDRH Guidelines List for FY 2022, CDRH, October 26, 2021

FDA Establishment Registration e Device Listing, 01 Ottobre 2021