Notice of Intent to Sole Source - Quality and Compliance Training Support
ID: FDA-CDRH-2025-126555-1Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Professional and Management Development Training (611430)

PSC

EDUCATION/TRAINING- TRAINING/CURRICULUM DEVELOPMENT (U008)

Set Aside

No Set aside used (NONE)

Original Source

https://sam.gov/opp/f80487647ed742d8bac0e8296000d4eb/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), intends to award a sole source contract for Quality and Compliance Training Support to the Association for the Advancement of Medical Instrumentation (AAMI). The primary objective of this procurement is to implement training for FDA staff in the Office of Product Evaluation and Quality (OPEQ) to facilitate the transition to the new Quality Management System Regulation (QMSR) and to enhance compliance and quality initiatives within the FDA. AAMI, with its extensive experience and unique position in the medical device industry, is recognized for its capability to deliver specialized training that aligns with FDA regulations and standards. Interested parties may submit capability statements by 12:00 p.m. ET on September 8, 2025, to Kimberly W. Davis at kimberly.davis@fda.hhs.gov.

    Point(s) of Contact
    Kimberly Davis
    kimberly.davis@fda.hhs.gov
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    No associated files provided.
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    Notice of Intent to Sole Source - Quality and Compliance Training Support
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