The FDA is proposing that nonclinical studies intended to support submissions to the agency meet higher quality management standards.
The proposed rule, published Aug. 24, would amend good laboratory practices for nonclinical studies to require facilities to undertake a comprehensive quality system approach to oversee these studies.
Nonclinical trials are conducted under laboratory conditions to evaluate the safety and toxicity of products and serve as a precursor to initial human studies.
The proposed rule takes into account current practices as well, such as multisite studies, offering industry flexibility in meeting the proposed standards.
The purpose of the rule is to improve and embed quality management into the planning, testing and reporting phases of nonclinical trials that support medical device applications. The holistic approach is designed to help maintain data quality and integrity, the FDA said.
The FDA seeks to increase accountability under the proposed rule, requiring additional standard operating procedures and management roles.
Under the proposed rule, management must document personnel compliance with the written procedures. The FDA does not, however, prescribe specific procedures to facilities in the rule, offering management the opportunity to design standards that best suit their facilities.
Comments are due within 90 days of publication in the Federal Register.
Read the proposed rule here: www.fdanews.com/08-23-16-ProposedRuleNonclinicalStudies.pdf. — José Vasquez