Device QMSR, Changes to Rules for LDTs Top FDA Regulatory Agenda

The FDA’s list of regulations it plans to propose or finalize in the next 12 months, released Tuesday, includes a number of proposed and final rules related to medical devices, including finalization of the Quality Management System Regulation due in December. Target release dates vary by rule.

Among the regulations in the proposed rule stage are:

• Laboratory-developed tests (August 2023);
• Current good manufacturing practice for outsourcing facilities (November 2023); and
• Clinical holds in medical device investigations (December 2023).

The rules the FDA plans to make final include:

• Administrative destruction of certain devices refused admission to the U.S. (June 2023);
• Revision of product jurisdiction regulations (October 2023); and
• Medical device quality system regulation amendments (December 2023).

The FDA also plans to issue an advanced notice of proposed rulemaking on product recalls sometime this month.

Read the regulatory agenda here.

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