75F40126SSN133891.pdf

This is a Sources Sought Notice (SSN) - a market survey designed to collect written information only. This is not a solicitation announcement for proposals and no contract will be awarded from this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. There is no RFQ, or other iteration of a solicitation associated with this Notice, and no telephone calls will be accepted requesting an RFQ package or solicitation. To protect the procurement integrity of any future acquisition that may arise from this announcement, information regarding a government technical point of contact will not be given and no appointments for presentations will be made.

The U.S. Food and Drug Administration (FDA), Division of Biomedical Physics (DBP), in collaboration with the Human-Device Interaction Lab and the Office of Science and Engineering Labs (OSEL), requires an upper limb prothesis system with a TASKA CX hand to collect more robust, high-quality interactions with emerging prosthetic technologies. The system will allow for accurate simulation of prosthesis control by an individual without upper limb loss and/or difference.

The Human-Device Interaction lab within OSEL addresses regulatory science research questions related to diagnostic, therapeutic, and assistive medical devices, and understanding human interaction with these medical devices requires tools that replicate their actual use in an unaffected population. A bypass prosthesis is a device worn over an intact limb that allows non-amputee users to operate a prosthetic system as if they had a limb difference. It typically consists of an external socket or frame that fits over the arm and interfaces with a prosthetic hand or terminal device (e.g., TASKA CX hand).

Bypass prostheses are commonly used for research, training, and demonstration purposes, enabling clinicians, engineers, and study participants to evaluate prosthetic technologies, control strategies, and user performance without requiring an amputation. Bypass prostheses can be configured in different geometries depending on the intended use. In one configuration, the prosthetic hand is mounted as a direct extension of the intact limb, resulting in a longer overall limb length that extends beyond the natural hand. In another configuration, the device incorporates an angled offset, positioning the terminal device so that it aligns more closely with the length and functional position of the intact limb.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 339113 - Surgical Appliances and Supplies Manufacturing; with a Small Business Size Standard of 750 employees, and you believe that your firm would be able to provide the FDA with the equipment and/or services described below, please submit an email containing capability statement(s) to timothy.walbert@fda.hhs.gov. Other than small business concerns are also encouraged to submit capability statements. An interested supplier shall include information about the company and demonstrate that it can meet all the following minimum performance requirements.

Critical to this acquisition is the use of “brand name or equal” when describing specific components and their salient performance characteristics in this RFI. In this case, “brand name or equal” applies to the inclusion of a TASKA CX prosthetic terminal device (hand) as part of the entire bypass prothesis system. Where an offeror submits an equal product, to be accepted it shall meet all of the specific physical, functional, and performance features listed below under Minimum Technical Requirements.

mailto:timothy.walbert@fda.hhs.gov

Minimum Technical Requirements for a Bypass Prothesis system are as follows for the system as a whole:

*Shall be a Bypass prosthetic system to include a TASKA CX or equal terminal hand;

*Fabrication of bypass prosthesis and integration of TASKA CX or equal hand shall be done by an organization with certified prosthetists and prior experience in myoelectric bypass prosthesis fabrication. Images of prior bypass prostheses made should be included in an offeror’s response to a solicitation;

* An option to transition the control method to pattern recognition using the same socket prosthesis should be included;

*Shall include staff familiarization, use and routine maintenance training on the TASKA CX bypass system. A firm delivering the TASKA CX bypass prosthesis training should provide evidence supporting their experience at correctly fitting the TASKA CX hand;

*Shall include a minimum one-year full hardware warranty from the date of Government acceptance;

*Contractor shall guarantee full device replacement at no additional cost to the Government for any manufacturing defects or operational failures during normal use as defined in the user manual;

*Warranty coverage shall include all associated shipping costs for replacement units.

Salient characteristics that the TASKA CX or “equal” terminal device (hand) shall meet are as follows:

*Shall be a 7 ¼” myoelectric hand with independently articulating digits, lateral/rotational compliance, IP67 water resistant, electronically multi-positional thumb, and wrist flexion; all cables, chargers, and batteries to power and charge the TASAK CX hand must be included;

*Hand must have the Quick Disconnect wrist;

*Hand must be attachable to a below elbow non-amputee carbon fiber socket with a removeable forearm shell that can accommodate various forearm sizes;

*Power switch with power button and charging port shall be integrated into the socket and easily accessible;

*Hand control method shall use 2-site proportional programmable control with suction EMG electrodes. EMG electrodes should NOT be installed directly into socket; EMG electrodes should be removeable from a fitted cloth sleeve;

*All cables, chargers, and batteries to power and charge the control system must be included.

Delivery Point

U.S. FDA-CDRH

Attn: To be completed at time of award.)

10903 New Hampshire Avenue Bldg. 62, Room 4215 Silver Spring, MD 20993-0002

Responses to this Sources Sought Notice shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar equipment and/or services. Though the target audience is small business vendors or small businesses capable of supplying a U.S.

product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, Unique Entity ID (SAM) number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm;

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include SAM Unique Entity Identifier (UEI) and size status) if not the respondent; particular to this Notice, the Government is interested in evidence of prior experience in myoelectric bypass prosthesis fabrication performed by certified prosthetists;

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the equipment and/or services the responding firm is regularly engaged in manufacturing or selling;

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above;

• If applicable, the offeror’s capability to initiate service within 5 business days of original notification, to include estimated historical on-site response time for the brand name and model of instrument in this requirement;

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested;

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available under;

• If a large business, provide whether subcontracting opportunities exist for small business concerns;

• Standard commercial warranty and payment terms;

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is required;

• Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes.

The Government is not responsible for locating or securing any information not identified in the response.

Interested Contractors must respond with capability statements submitted ONLY by email on or before 2:00pm (Central Time in Jefferson AR) on May 29, 2026 to Tim Walbert at timothy.walbert@fda.hhs.gov. Please reference 75F40126SSN133891 in the Subject line of the e-mail.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Responses with weblinks will not be opened or viewed. Responses must demonstrate capability, not merely affirm the respondent’s capability (i.e. the response must go beyond the statement that, “XYZ company can provide the instrument, technical support etc.”).

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre-solicitation synopsis or combined synopsis/ solicitation may be published on SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.

mailto:timothy.walbert@fda.hhs.gov