Attachment A - Draft Statement of Work.pdf

PDF 523 KB Posted Oct 30, 2026

Attached to: FDA/CDRH Scientific Technical Capacity for Regulatory Review
Solicitation number: 75F40127Q00006
Issued by: Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services

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Written by GovTribe AI · Oct 30, 2026

This is a Statement of Work (SOW) for RFQ 75F4012Q00006, soliciting expert consultant services for the FDA's Center for Devices and Radiological Health (CDRH).

The CDRH seeks to establish a Blanket Purchase Agreement (BPA) to provide scientific and technical consultants for regulatory review of medical devices across the total product lifecycle. The contractor must maintain a database of expert consultants across numerous disciplines including anesthesiology, biomedical engineering, cardiology, chemistry, computer science, cybersecurity, data science, digital health, epidemiology, general engineering, infectious diseases, neurology, optics, physics, psychiatry, public health, regulatory science, software engineering, statistics and biostatistics, sterilization, toxicology, and virology, among others. Key responsibilities include: providing expert consultation on 510(k), PMA, and De Novo marketing applications; conducting presubmission consultations; participating in meetings with internal and external stakeholders; performing regulatory research and data analysis; and developing written reviews and supporting documentation. The BPA contract type allows for Firm Fixed Price, Labor-Hour, and Time & Materials Call Orders. The estimated period of performance spans one base year (January 30, 2027 – January 29, 2028) plus four optional one-year periods and an additional six-month extension option. Services will be provided both on-site at FDA's White Oak Campus in Silver Spring, Maryland and remotely. The contractor must maintain detailed Government Furnished Property (GFP) inventory records, comply with extensive security requirements including Public Trust Position – Tier 2 background investigation, complete mandatory FDA training, and adhere to strict information security, privacy, and incident response protocols.

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RFQ 75F40127Q00006

SCIENTIFIC TECHNICAL CAPACITY FOR REGULATORY REVIEW

STATEMENT OF WORK

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

NAICS Code: 541611 Administrative Management and General Management Consulting

Services

RFQ Issue Date: TBD

1 BACKGROUND

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring 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 mission of the FDA’s Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. The CDRH ensures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. The CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products that CDRH oversees. The CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and ensuring consumer confidence in devices marketed in the United States.

To assist the CDRH in fulfilling its mission, CDRH seeks expert consultants to assist CDRH’s Offices with regulatory review across the total product lifecycle. CDRH requires consultants that have skilled experience to assist with medical device regulatory review work and supporting scientific activities, such as research, cybersecurity and digital health consultations, regulatory consultations and auditing, and interacting with industry and patients.

The CDRH requires consultants that have sufficient skilled capacity in many science, engineering, and clinical specialties, including Anesthesiology, Biology, Biomedical Engineering, Chemistry, Clinical laboratory testing, Computer Science and Engineering, Consumer Safety, Cybersecurity, Data Science, Dentistry, Digital Health, Epidemiology, Gastroenterology, General Engineering, Health Science, Infectious Diseases, Interdisciplinary Engineer/Scientist, Molecular testing, Neurology, Optics, Patient Engagement, Physics, Psychiatry, Public Health, Pulmonology, Reprocessing medical devices, Social Scientist, Software Engineering, Statistics and Biostatistics, Sterilization, Toxicology, Urology, Veterinary Medicine, and Virology.

2 OBJECTIVE

The primary objective of this Blanket Purchase Agreement (BPA) is to provide the CDRH with a vehicle to acquire the support services of advanced professional and scientific consultants to assist CDRH’s Offices with regulatory review across the total product lifecycle, including the supporting scientific, engineering, clinical, and regulatory activities.

The services provided will be critical scientific expertise and capacity in support for the evaluation of the continued performance, safety, and effectiveness, with respect to devices approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of medical conditions by the FDA.

3 SCOPE

The Contractor shall provide professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. The consultants will foster and develop methodologies and analyses that ensure medical devices released to the market are aligned with all of the FDA and CDRH requirements and safety protocols.

Under supervision, the contractor shall provide support to managers and staff, assist with office operations, projects and special assignments. Coordinates logistical details associated with the departmental operations and prepares documentation for the Offices specified above.

Responsibilities include providing consultation related to supporting medical device reviews;

participating in meetings and teleconferences; coordinating meetings with internal and external stakeholders; correspondence; research and regulatory science; data analysis; writing detailed documents and reports; and other administrative office tasks related to the CDRH’s projects.

The contractor shall provide expert consultants across a variety of processional and scientific disciplines to assist the CDRH with the regulatory responsibilities of the CDRH. Subject matter specialties includes:

• Anesthesiology;

• Super Intelligence/Machine Learning (SI/ML);

• Biology;

• Biocompatibility;

• Biomedical Engineering;

• Cardiology;

• Chemistry;

• Computer Science and Engineering;

• Consumer Safety;

• Cybersecurity;

• Data Science;

• Dentistry;

• Digital Health;

• Epidemiology;

• Expertise in diagnostics testing, such as molecular testing, serology testing, antigen testing, infectious disease testing, clinical laboratory testing;

• Gastroenterology;

• General Engineering (including Interdisciplinary, Electrical, Software, Biomedical, Optics,

• Human Factors, Mechanical);

• General Microbiology;

• Health Science and Tech Transfer;

• Infectious Diseases;

• Microbiology with expertise in virology, toxicology, chemistry as it relates to material compatibility, ultraviolet sterilization, and in reprocessing of medical devices in real world settings;

• Neurology;

• Optics;

• Patient Engagement;

• Pulmonology;

• Physics;

• Psychiatry;

• Public Health;

• Regulatory Science;

• Reprocessing medical devices;

• Scientific expertise in the regulation and approval and of medical devices;

• Social Science;

• Statistics and Biostatistics;

• Sterilization;

• Toxicology;

• Urology;

• Veterinary Medicine; and

• Virology.

The Contractor shall continuously manage a database of expert contract support staff to be able to provide expert consultants across a variety of disciplines to assist the CDRH with the CDRH’s regulatory responsibilities.

4 TASKS

4.1 PROJECT MANAGEMENT

4.1.1 Kick-off Meeting

Within ten (10) business days after the start of the period of performance for the first Call Order awarded under this Blanket Purchase Agreement (BPA), the Contractor shall participate in a Kick-Off Meeting with CDRH management and the Contracting Officer’s Representative

(COR).

The Contractor shall prepare summary meeting minutes, detailing the discussion held, and provide a copy of the minutes to the COR within five (5) business days after the meeting.

4.1.2 Monthly Meeting and Report

Pursuant to each awarded Call Order, a monthly meeting (of a minimum length of 30 minutes) shall be held with the Contractor’s program manager and COR. The Contracting Officer (CO)/Contract Specialist (CS) will attend at his/her discretion unless directed otherwise by the COR. Prior to each meeting, the Contractor shall submit a meeting agenda. The Contractor shall submit a monthly report including, but not limited to, the following items:

• BPA Administration and Funding,

• Current Contractor status, and

• Recruitment Status Risks and Issues.

4.2 AD-HOC EXPERT CONSULTATION

The Contractor shall serve as Consultants across a variety of professional and scientific disciplines to assist with the regulatory responsibilities of the CDRH. This work often involves complex, novel, controversial, and time-sensitive issues.

The Contractor shall perform duties as specified in each Call Order including, but not limited to, the following:

• Provide expert consultation to review teams in support of reviews for o 510(k), PMA and De Novo marketing applications o Presubmissions;

o Emergency use authorizations

• Participate in on-site or remote meetings to discuss these device submissions with both internal and with external sponsors;

• Develop written reviews and other documents as needed

• Assist CDRH Staff as needed with projects including but not limited to:

o Performing research, regulatory science, and development of regulatory science tools, o Conducting interviews, o Attending, leading, or otherwise participating in meetings, o Data Analysis, o Documenting analyses, o Communication with internal and external stakeholders; and o Writing drafts of internal and external communication.

4.2.1 Areas of Expertise

In alignment with the responsibilities of each of CDRH’s Offices, the contractor personnel shall have professional, scientific, and non-scientific expertise in appropriate fields to assist CDRH staff. Specific requirements will be addressed in each Call Order. Potential disciplines of expertise are related to the medical devices regulated by each Office. This includes, but is not limited to, the following:

• ophthalmic, anesthesia, respiratory, ear, nose and throat (ENT) and dental medical devices;

• cardiovascular devices;

• reproductive, gastro-renal, urological and general hospital devices;

• surgical and infection control medical devices;

• neurological and physical medicine devices;

• orthopedic devices; and,

• in vitro diagnostic, radiological health, and mammography quality standards programs;

• clinical device trials and biostatistics;

• public health, digital health, artificial intelligence; and

• computer science, data science, and regulatory research.

4.2.2 Position Titles, Job Categories, and Descriptions

The Contractor shall conduct recruitment and retention efforts to provide the following expert consultant support satisfying the requirements of this Statement of Work (SOW). Background checks for conflict of interests (COIs), information security, and ethics training for these positions will be essential for all persons connected with FDA to ensure that no real or perceived ethical conflicts exist. The personnel proposed shall possess the required education, experience, and ability to obtain security clearances, if applicable, to perform under this BPA:

• Executive Consultant

• Senior Executive Consultant

• Principal

• Project Manager

• Program Manager

• Senior Program Consultant

• Senior Consultant

• Senior Specialist I

• Technical Consultant

• Consultant I

• Consultant II

• Consultant III

• Consultant IV

• Analyst I

• Analyst II

• Analyst III

• Analyst IV

• Analyst V

• Senior Project Analyst

• Project Analyst

• Technician

• Strategic Analyst I

• Strategic Analyst II

• Strategic Analyst III

• Strategic Analyst IV

• Subject Matter Expert I

• Subject Matter Expert II

• Subject Matter Expert III

• Subject Matter Expert IV

• Subject Matter Expert V

• Subject Matter Expert VI

• Subject Matter Expert VII

• Subject Matter Expert VIII

4.2.3 Labor Category Roles And Responsibilities

Table 1: Labor Category Roles and Responsibilities

Labor Category Roles and Responsibilities

Senior Executive Consultant

Has a wide range of industry experience. Typically has technical or functional expertise and is an authority in a major firm methodology. Acts as either subject matter expert or as senior account executive.

Experience: Master’s Degree, 7 years of experience

Executive Consultant

Has experience in consulting and managing large ($1 million+ projects) and multiple client relationships. Typically has technical or functional expertise in major firm methodologies. Capable of planning and directing organizational policies, objectives, and initiatives.

Experience: Master’s Degree, 10 years of experience

Principal

Has experience in mid-level medical, scientific or engineering positions within industry or academic equivalents. Provides scientific or technical oversight to an engagement. Has technical and functional expertise in a major firm methodology. Defines agenda and project objectives. Drives content and provides thought leadership.

Experience: Master’s Degree, 5 years of experience

Project Manager

Oversight and primary management of projects undertaken by the firm, and day-to-day responsibility for a successful engagement. Has technical and functional expertise in major firm methodologies.

Experience: BA/BS, 5 years of experience

Program Manager

Responsible for all aspects of the program’s success. Responsible for the development and submission of contract deliverables. Sets deadlines, assigns responsibilities, and monitors and summarizes progress of project.

Responsible for maintenance of task assignments, subcontract agreements associated with Program to include tracking of all modifications, invoices, submission, and incremental funding. Ensures that all programs are on track to meet or exceed contractual performance goals within the guidelines of the operating budget and program deliverables. Leads the front-line project staff to ensure that the contract performance is met on a timely basis.

Scopes, plans, budgets, resources, and manages related projects. Interfaces and collaborates with the clients to achieve operational efficiency and client/customer satisfaction. Responsible for the development of budget and financial reports and program metrics. Develops and maintains long-term customer relationships.

Responsible for employee recruitment and development. Adheres to applicable security, labor, and federal contracting laws. Plans daily activities within the guidelines of company policy, job description and supervisor’s instruction in such a way as to maximize personal output.

Senior Program Consultant

Leads or supports major work segments, as well as the completion of other project work streams and deliverables. May also lead project modules or work activities as appropriate. Within defined objectives and with considerable latitude, performs in a professional position supporting complex client improvement efforts by performing/leading one or more of the following: scientific analysis/negotiations, business financial analysis, strategic/tactical business planning, business process reengineering, A-76 studies, budget preparation and analysis, contract reconciliation, economic analysis, contractor cost/schedule analysis, MIS development, and documentation development. Develops and/or reviews study plans and monitors/reports project status. Oversees development of analytical and computational techniques and methodology for problem solutions. Manages process and data modeling in support of the planning and analysis efforts using both manual and automated tools. Identifies all task responsibilities and reports any changes or suggestions accordingly to the client.

Experience: BS/BA, 7 years of Experience

Senior Consultant

Leads or supports major work segments, as well as the completion of other project work streams and deliverables. May also lead project modules or work activities as appropriate.

Experience: BS/BA, 5 years of Experience

Senior Specialist I

Has specialized knowledge to address a portion of the project. Works under the direction of senior project team members to accomplish project objectives. Interacts with client management & project team. Completes research, manages project processes and performs relevant analysis. Works on projects for clients of various sizes, complexity and visibility. Analyzes, designs, produces, tests and implements business and/or technical solutions.

Experience: BS/BA, 3 years of experience

Technical Consultant

Leads project modules or work activities as appropriate. Can employ special skills independently on assigned research projects and is experienced in reasoning and evaluation techniques for complex problems, and in preparing project reports and briefings.

Experience: BS/BA, 5 years of experience

Minimum Education: Bachelor’s Degree

Consultant IV

Provides technical, scientific and/or functional expertise in one or more key areas. Works directly with senior client management. Provides guidance, direction, best practices knowledge for key deliverables of the project. Is capable of directing research, managing project processes, and performing relevant analysis. Oversees data collection and analysis tasks that support management decision-making. May also conduct cost benefit analyses.

Experience: BS/BA, 5 years of experience

Consultant III

Targeted technical and/or functional expertise in one or more key areas.

Works under direction of senior client management. Provides insights, best practices and guidance for key portions of the project. Is responsible for completing research, managing project processes and performing relevant analysis. Participates in data collection and analysis tasks that support management decision-making. May also conduct cost benefit analyses.

Experience: BS/BA, 4 years of experience

Consultant II

Targeted technical and/or functional expertise in one or more key areas.

Works in collaboration with more senior project team members to accomplish project objectives. Interacts with senior client management.

Provides insights, best practices and guidance for key portions of the project.

Is responsible for completing research, managing project processes and performing relevant analysis. Works on projects of various sizes, levels of complexity and visibility. Participates in data collection and analysis tasks that contribute to the development of business cases to support management decision-making. May also conduct cost benefit analyses.

Experience: BS/BA, 3 years of experience

Consultant I

Supports the analysis, design, development and implementation of major work segments, as well as the completion of other project work streams and deliverables. May also lead project modules or work activities as appropriate.

Experience: BS/BA, 2 years of experience

Analyst V