On 16 October 2020 the Center for Devices and Radiological Health (CDRH) of FDA published the list of guidelines it intends to publish for fiscal year 2021 (FY 2021).
Moreover, CDRH also announced that it undertakes to review the final guidelines previously published and to update or delete those documents that no longer represent the current FDA view on a given regulatory issue.

CDRH guidelines for fiscal year 2021 (FY 2021) USA
CDRH guidelines for fiscal year 2021 (FY 2021)

CDRH guidelines in 3 lists

The CDRH has decided to divide the guidelines into 3 lists:

  • The A-list: guidelines that FDA intends to publish;
  • The B-list: documents that FDA intends to publish as permitted resources during FY 2021;
  • Retrospective review list: final guidelines published in 1981, 1991, 2001 and 2011 which are subject to retrospective review.

Some guidelines planned for 2021 concern the Safer Technologies program (STeP) for Medical Devices, clinical decision software (CDS) and documents based on the safety and performance of Medical Devices. It is possible to consult the complete list by linking to the following link: CDRH Proposed Guidances for Fiscal Year 2021 (FY 2021)

FY 2021: Did you renew the Establishment Registration?

Each year FDA requires the payment of an annual fee for the renewal of the Establishment Registration and Device Listing, as required by the 21 CFR Part 807.
There is little time: by December 31, 2020 it is necessary to carry out this renewal at FDA for the next year (2021).
The tax for fiscal year 2021 is $ 5,546 (U.S.) for each establishment and there are no exemptions or reductions: all establishments must may the registration fee. In addition, all information related to the Establishment Registration shall be sent in electronic form.

Do you need help? Contact us for a consultation!

Thema can support you in the task and perform all the formalities required by FDA for this renewal. Moreover, we remind you that, thanks to THEMA USA and to strategic partnerships, THEMA also offers the service of U.S. Agent and U.S. Initial Importer.

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CDRH Guidances for FY 2021

FDA Establishment Registration e Device Listing