Association for Diagnostics & Laboratory Medicine // Advocacy & Outreach // Comment Letters // 2016 Comment Letters

2016 Comment Letters

In July 2023, we changed our name from AACC (short for the American Association for Clinical Chemistry) to the Association for Diagnostics & Laboratory Medicine (ADLM). The following page links to resources that were written prior to the rebranding and/or mentions events that took place prior to the rebranding and that contain mentions of the association’s old name.

AACC continually tracks legislative and regulatory issues of importance to clinical laboratories and the clinical laboratory profession. This is a listing of AACC's 2016 comment letters. AACC commented on a wide range of topics to federal and state authorities.

2016 Comment Letters

2016 Legislative and Regulatory Issues

AACC Endorses Restrictions on Agency Use of Guidance Documents

AACC Recommends FDA Defer to CLIA Oversight of NGS Testing

AACC Identifies for FDA Limits of Gene Variant Databases

AACC Provides Input to Senate HELP Committee on LDT Regulatory Oversight

AACC and healthcare partners continue to pursue CDC harmonization funding

AACC Opposes VA Proposal to Extend Nurses Scope of Practice to Labs

AACC urges CMS to use rulemaking process regarding CLIA equivalency for nursing degrees

Healthcare groups ioin AACC in support of federal funding for harmonization

AACC urges the Senate to require FDA justification of guidance documents

AACC urges Senate delay of LDT guidance

AACC joins effort in support of additional funds to stop the Zika virus

AACC submits comments to FDA regarding analytical validation of LC-MS

AACC supports House language delaying FDA LDT guidance

AACC provided testimony at FDA workshop on the regulation of Mass Spectrometry

AACC joins the March of Dimes in support of emergency funding for CDC to prepare for Zika virus

AACC Provides FDA with feedback on reporting of genetic test results

AACC Joins Friends of AHRQ to Support Restoration of Agency’s Funding

Laboratory Community Urges Federal Funds for Harmonizing Test Results

AACC joins Children's Health groups in raising concerns about OHRP changes to Common Rule

AACC Opposes OHRP Limits on Use of Residual Specimens