SOO Device Development Course RFI_aspr_09152026.docx

Period of Performance

November 2-3, 2026, 2-day training (Proposed)

Place of Performance Constitution Center, Washington, DC

Product Service Code (PSC) U004 - Education/Training Scientific Management

North American Industry Classification System (NAICS) Code 611430 = Professional and Management Development Training (size standard $15 million) NOTE: All prospective contractors must be registered in the System for Award Management (SAM.gov) database to be awarded a contract.

Statement of Objectives:

The Center for the Biomedical Advanced Research and Development Authority (BARDA) is seeking potential contractors that can provide an in person, instructor-led course focused on the regulatory, commercial, and scientific considerations required to bring a medical device successfully to market, based on the below learning objectives. The Contractor will provide a qualified instructor for the course. The requested Period of Coverage is from November 2-3 for 2-day training (proposed; but other options possible).

Scope: Contractor will perform in-person, instructor led training on the topic of Device Development for Scientists. The course will be for up to 30 attendees in the Constitution Center Washington DC. Course materials (ex. PowerPoint Slides; workbooks) are the responsibility of the Contractor and must follow 508 compliance. (https://www.section508.gov/). Final Course materials should be submitted to the CO at least 2 business days prior course commencement.

A copy of the Statement of Objectives (SOO) is attached to this RFI.

Learning Objectives:

· Discovery pathway for

· Diagnostics

· Therapy

· Software as device

· MOU, target identification and validation

· Device Discovery/Concept

· Preclinical development

· Decision milestones and go/no go criteria.

· Target product profile

· Nonclinical studies

· IDE studies

· Phases of clinical trials; what data is generated and how does that inform subsequent trial design?

· IDE studies and exempts

· Drafting a label and package inserts

· Difference between academia and industry

· US patents and exclusivity

· Understanding the regulatory pathway

· Risk classification and Accelerated programs ( i.e. BDDs, STeP)

· Class I (Low Risk)

· Class II (Moderate Risk)

· Class III (High Risk)

· De Novo Classification

· Submissions

· 510(k)

· De Novo

· PMA submission

· Accelerated program

· Breakthrough Device Program

· Safer Technologies Program

· Recalls in post approval process

· Joint review by CMS and FDA (RAPID and TEMPO Pilot programs) in coding and reimbursement

The following information should also be included:

· Resumes and credentials of proposed trainers. Trainers must have 5+ years of experience working on medical device development including all topics covered above including educational and field experience. Trainers should have a master’s degree or higher in a related fields to the course subject.