SAM #FDA-SSN-134448

FDA seeks Protective Clothing Blood Penetration Resistance Tester for regulatory testing

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), on behalf of the Center for Devices and Radiological Health (CDRH), is seeking sources for a Protective Clothing Blood Penetration Resistance Tester for regulatory testing. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Office of Acquisitions and Grants Services (OAGS) - Center for Devices and Radiological Health (CDRH) - OEMs and Vendors: - No specific OEMs or vendors are named in the notice - Products/Services Requested: - Protective Clothing Blood Penetration Resistance Tester - Used for testing viral penetration resistance in level 4 medical gowns - Must have at least four independent test positions - Automatic timer and real-time pressure monitoring - Autoclavable test cells - Integrated touchscreen interface - Compliance with ASTM F1670 and ASTM F1671/F1671M standards - Delivered as a turn-key solution with all hardware, software, supplies, and accessories - Installation, IQ/OQ documentation, warranty, and operator training - Unique/Notable Requirements: - System must be newly manufactured (not refurbished) - Delivery and installation required at Winchester Engineering and Analytical Center Laboratory, Winchester, MA - Vendors must provide capability statements, technical information, descriptive literature, and pricing - Warranty and technical support required for at least one year from FDA acceptance

Description

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Center for Devices and Radiological Health (CDRH), in order to determine if there are existing small business sources capable of providing a Protective Clothing Blood Penetration Resistance Tester. Other than small business concerns, especially vendors who may be able to offer domestic products are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov.

Background:

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Winchester Engineering and Analytical Center Laboratory (WEAC), requires the purchase of one (1) Protective Clothing Blood Penetration Resistance Tester to support future regulatory testing.

The Protective Clothing Blood Penetration Resistance Tester will be used to perform a verification method to test for viral penetration of level 4 medical gowns at the request of CDRH. Level 4 medical gowns provide the highest level of protection against bloodborne pathogens; they are critical in protecting healthcare workers used during risk medical procedures. The gold standard in testing is performed manually and takes specific expertise and an excess of 100 hours to complete. This automated tester would cut hands-on time by 75% while increasing consistency and repeatability to the test.

Minimum Technical Requirements: Shall provide four (4) independent working positions capable of running four individual tests simultaneously. Shall include an automatic timer capable of initiating and terminating testing without manual intervention. Shall accommodate test samples with minimum dimensions of 70 mm × 70 mm. Shall be capable of achieving a minimum test pressure of 13.8 kPa. Shall provide real-time pressure monitoring during testing. Shall automatically monitor and adjust pressure throughout the test cycle. Shall operate using compressed air. Shall include autoclavable test cells. Shall be capable of processing a minimum of 60 mL of fluid in each test cell. Shall include an integrated touchscreen user interface. Shall be capable of performing testing in accordance with ASTM F1670 and ASTM F1671/F1671M standards.

Additional System Requirements: The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration. Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures. The Contractor shall provide Installation Qualification (IQ) and Operational Qualification (OQ) documentation and services for the instrument, including execution and documentation of IQ/OQ protocols, to verify that the system is installed and operates in accordance with the manufacturer's specifications and the requirements of this procurement. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, and immediate access to replacement parts. Phone and email technical support shall be included for a minimum of one (1) year.

Delivery/Place of Performance: FOB Point Destination. All items shall include shipping, handling, installation, IQ/OQ, and inside delivery to the destination identified herein. U. S. Food and Drug Administration Winchester Engineering and Analytical Center 109 Holton Street Winchester, MA 01890 Delivery shall be coordinated with the Contracting Officer Representative at least 48 hours in advance

Period of Performance: Delivery shall occur within 120 days from date of award.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. 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 identification (UEI) 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 information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments 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 UEI number and size status) if not the respondent. Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered items/services meet the technical requirements identified above. If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on. 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. Identification of AbilityOne Contracts available that can meet the requirement 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 needed. Informational pricing is desired. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before June 23, 2026, by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN-134448.

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 and solicitation may be published in sam.gov. 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. Though this is not a request for quote, informational pricing for the service would be helpful.

This is a sources sought announcement, a market survey for 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. No telephone calls will be accepted requesting an RFQ package or solicitation. There is no RFQ package or solicitation. In order to protect the procurement integrity of any future procurement, if any, that may arise from this announcement, information regarding the technical point of contact will not be given.

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