Medical Device Development Instructor- Led Training

identify potential contractors capable of providing an in-person, instructor-led course on Device Development for Scientists. The course will focus on the regulatory, scientific, and commercial considerations involved in developing medical devices, obtaining U.S. Food and Drug Administration (FDA) clearance or approval, and successfully bringing medical devices to market. The Contractor shall provide qualified instructor(s) and all required course materials. The proposed training will be conducted over two days, November 2�3, 2026, at the Constitution Center in Washington, DC. Alternative dates may be considered based on instructor availability and mutual agreement. A copy of the Statement of Objectives (SOO) is attached to this Sources Sought Notice/RFI. 2. Scope The Contractor shall provide in-person, instructor-led training on Device Development for Scientists for up to 30 participants at the Constitution Center in Washington, DC. The Contractor shall be responsible for developing and providing all course materials, including presentation slides, workbooks, handouts, and other instructional materials. All electronic course materials shall comply with applicable Section 508 accessibility requirements. Final course materials shall be submitted to the Contracting Officer (CO) at least two business days prior to the start of the training. 3. Learning Objectives The training should address, at a minimum, the following topics: Discovery Pathways Diagnostics Therapeutics Software as a Medical Device (SaMD) Target identification and validation Device Discovery and Concept Development Preclinical development Decision milestones and go/no-go criteria Target product profile Nonclinical studies Investigational Device Exemption (IDE) and Clinical Studies IDE studies and exemptions Stages/phases of clinical studies Types of data generated during clinical studies and how the data inform subsequent study design Labeling Drafting medical device labels and package inserts Academia and Industry Key differences between medical device development in academia and industry Intellectual Property U.S. patents and exclusivity considerations Regulatory Pathways Understanding the FDA regulatory pathway Device risk classifications: Class I � Low Risk Class II � Moderate Risk Class III � High Risk De Novo Classification Regulatory submissions: 510(k) De Novo Premarket Approval (PMA) Expedited/accelerated programs: Breakthrough Devices Program Safer Technologies Program (STeP) Post-Market Considerations Medical device recalls and the post-market process Coverage, Coding, and Reimbursement FDA and Centers for Medicare & Medicaid Services (CMS) coordination Relevant pilot programs, including RAPID and TEMPO, as applicable Coding and reimbursement considerations 4. Instructor Qualifications Proposed instructor(s) shall have: A minimum of five years of relevant experience in medical device development; Demonstrated experience with the regulatory, scientific, and commercial topics identified in this notice; Relevant educational and professional experience; and A master's degree or higher in a field related to the course subject matter. Respondents should provide resumes or curricula vitae (CVs) for proposed instructor(s) demonstrating the required qualifications and experience. 5. RFI Questions Interested parties are requested to address the following questions in their response: Are you capable of providing in-person, instructor-led classroom training covering the topics and requirements described above? Do you have relevant past performance providing similar medical device development or regulatory training? If so, please provide a brief description of your relevant experience. Are you available to provide a two-day, onsite training in Washington, DC, on November 2�3, 2026? If not, please identify alternative dates during which you would be available. Please provide an estimated cost for providing the two-day training for up to 30 attendees. The estimate should include course materials, instructor travel, and any other applicable costs. This information is requested for market research and acquisition planning purposes only. Do you currently offer this training, or similar training, through an existing Government contract vehicle, including a GSA Multiple Award Schedule? If so, please identify the applicable contract vehicle and contract number. Please provide resumes or CVs for the proposed instructor(s) demonstrating their relevant education, qualifications, and medical device development experience. 6. Response Instructions Please submit responses no later than September 23, 2026, at 2:00 PM ET to: Contracting Officer: La Vivian Peasant; Email; lavivian.peasant@hhs.gov Responses should clearly identify the company name, point of contact, telephone number, email address, UEI, business size/status, and applicable Government contract vehicles, if any. 7. Disclaimer This Sources Sought Notice/RFI is issued solely for market research and acquisition planning purposes. It does not constitute a Request for Proposal (RFP), Request for Quotation (RFQ), Invitation for Bid (IFB), or commitment by the Government to issue a solicitation or make an award. Responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. The Government will not reimburse respondents for any costs incurred in preparing or submitting information in response to this notice. The information received may be used by the Government to determine the appropriate acquisition strategy, including the availability and capability of potential sources.