Notice of Intent to Sole Source - Quality and Compliance Training Support

Notice of Intent to Sole Source - Quality and Compliance Training Support

The Food and Drug Administration (FDA) intends to award a sole source, firm fixed price type contract to Association for the Advancement of Medical Instrumentation, 901 N. Glebe Road, Suite 300

Arlington, VA 22203, in accordance with the authority under FAR Part 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements. This procurement is being conducted in accordance with Federal Acquisition Regulations (FAR) Part 15. The NAICS code is 611430 - Professional and Management Development Training.

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The primary objective of this requirement is to support CDRH’s strategic vision for the Compliance and Quality program and CDRH reviewers by (1) implementing existing training for the staff in the Office of Product Evaluation and Quality (OPEQ) to support the regulatory transition of 21 CFR Part 820 from the Quality System Regulation (QS Reg) to the Quality Management System Regulation (QMSR). This training addresses the integration of the ISO14971 standard for risk-management in medical devices, with the ISO13485 standard for quality management system requirements for medical device manufacturers and supporting CDRH’s capability for CDRH staff to deliver the training in the future; and (2) deliver training on the new QMSR (21 CFR Part 820) which will go into effect on February 2, 2026. This will enable the FDA to strengthen its device compliance, quality, and patient-safety initiatives by aligning current skills, work processes, and practices with the quality-focused strategic vision.

Association for the Advancement of Medical Instrumentation (AAMI) is a non-profit organization whose mission is advancing the safety and effectiveness of health technology. AAMI is a representative body for the U.S. on international standards for the medical device industry. As such, CDRH has had a long-standing collaboration with AAMI to develop content and training that is aligned with FDA’s interpretation of current regulations and standards for industry. Currently, no other organization holds the representation on international standards for medical devices and provides broad training. AAMI has extensive experience in training development and incorporating FDA’s perspective into the material developed.

AAMI has been in both FDA and HHS workspace doing standards development, communications, training, and industry development for several years. They are exceptionally knowledgeable about FDA’s priorities and mission.

FDA staff need to have training and expertise in quality operations and organizational excellence with an understanding of the association to the quality system regulations and international standards; this is necessary to support the regulatory modifications that are part of the program. Without the training being made available for staff, oversight efforts will be impacted and cause delays in reviewing submissions. Additionally, FDA has been significantly augmenting new staff, who would require the new program training.

AAMI is uniquely positioned to apply its knowledge base around the FDA regulatory requirements, which would save valuable time and effort by being able to quickly integrate once a contract is awarded. Moreover, FDA has no knowledge of any other vendor who has the same or similar capabilities to provide specialized training to equip FDA employees with the skills needed to support the CfQ program.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written response (i.e., capability statement) which clearly supports and demonstrates its ability to perform the requirements. Any response must be received by the response date and time of this notice. Any response will undergo a review to determine if the respondent can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government.

Response Date: 12:00 p.m. ET on Monday September 8, 2025. Responses must be emailed to Kimberly W. Davis @ Kimberly.davis@fda.hhs.gov

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