What does LATD mean in LABORATORY

Laboratory Approval and Testing Division (LATD) is a division of the U.S. Food and Drug Administration (FDA) responsible for approving and monitoring the safety, quality, performance, and efficacy of laboratory tests. LATD also reviews laboratory procedures for compliance with FDA standards and provides technical support on laboratory issues.

LATD is primarily responsible for approving new laboratory test methods, monitoring test method performance, reviewing laboratory testing protocols, providing guidance to industry on laboratory testing requirements, overseeing the development of clinical trials involving laboratory tests, providing technical assistance to laboratories conducting regulatory-required testing activities, evaluating requests for approval of tests that have been modified or changed from an approved formulary source, and monitoring international trends in laboratory testing techniques.

LATD provides guidance on FDA regulations related to medical device clinical trial design as well as best practices related to preclinical study design. Additionally, the division offers advice to help laboratories ensure their products meet FDA requirements with respect to labeling accuracy and compliance with good manufacturing practices (GMPs).

The Laboratory Approval and Testing Division conducts comprehensive reviews of proposed tests that measure physical characteristics such as weight or volume; biochemical components such as blood components; molecular methods including genetic markers; or physiological properties such as heart rate or body temperature. Additionally, requests for approval for modified or changed forms of existing tests are reviewed before use in clinical trials or other applications.

The Laboratory Approval and Testing Division monitors both individual test procedures used in diagnostic laboratories as well as specific devices utilized by research laboratories through periodic reviews conducted by expert staff members. The studies conducted by these expert staff members focus on assessment activities within an approved test procedure such as accuracy, precision, sensitivity/specificity ,and overall performance results.

You can submit a request for approval from the Laboratory Approval & Testing Division using either Form 3500-1M (for medical device) or Form 3500-2M (for laboratory developed tests). All submissions must include sufficient information demonstrating that the proposed test meets all applicable regulatory requirements; additional documents may be requested by FDA staff during review process. Your submission should also include contact information where follow up questions can be addressed promptly.

All requests are initially reviewed by FDA staff before being referred out to a panel of expert reviewers who evaluate its contents according to specified criteria set forth in scientific guidelines established by the agency. Following this evaluation period, recommendations are then provided back to the agency’s central office regarding whether the product should receive approval or not based upon available data at that time.

The timeline associated with approval depends largely upon several factors such as complexity of review needed prior to issuing a decision; degree in which data has already been generated related to product timeframe established; degree which data analysis may need additional support; completeness initial submission made; and number other requests currently being considered along same timeframe proposed product submission date set forth by applicant requesting review status determination period cut off example summary basis required parameters associated justification set forth herein example statement response issuance basis present example set forth document basis concluded deem appropriate application submission purposes example purposes best understood relevant parties consult current representative examples understanding established parameters based representatives contribute respective contributions relevant documentations best valued contributors relevant proceedings applicable terms conditions applied.

During assessment process you will typically need to provide periodic reports updating your progress towards achieving desired objectives goals stated within scope program previously outlined standard accepted procedures requirement applicants submitting requests prior completing comprehensive assessments period cut off sample basis required expected field operations activities involved sample projects considerations taken account examples viewed consistent approved documentation provided party representatives contributing content contributions valid analysis projects handled division.