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Medical Devices / Regulatory Affairs

FDA Drops Biennial Inspection Requirement for Biologics

Jan. 31, 2018
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The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities registered as medical device establishments and adopting a more flexible, risk-based approach to how often the agency will conduct inspections.

The rule will become effective 135 days after its Jan. 26 publication in the Federal Register, unless there are significant adverse comments from stakeholders.

The agency said the current biennial inspection requirement for biological product facilities is considered outdated, since the Food and Drug Administration Safety and Innovation Act in 2012 (FDASIA) established a risk-based inspection schedule.

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