2022-20985. Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a correction to the notice of meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of September 2, 2022. The correction is being made to reflect a change to the sponsor's name. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993-0002, 301-796-6313, [e-mail], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of September 2, 2022 (87 FR 54221), FDA announced that a meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee would be held on October 20, 2022. On page 54222, in the second column, in the Agenda portion of the document, the second sentence “On October 20, 2022, the committee will discuss, make recommendations, and vote on clinical information related to the De Novo request for the AvertD Test sponsored by SolvD, Inc.” is changed to read as follows: “On October 20, 2022, the committee will discuss, make recommendations, and vote on clinical information related to the De Novo request for the AvertD Test sponsored by SOLVD Health.”

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

Dated: September 22, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.