Requirements_Document_Lithium_Batteries_CDRH-2026-135728 Final.docx

U.S. Food and Drug Administration Office of Acquisitions and Grants Services Requirements Document: Implantable Medical-Grade Primary Lithium Batteries U.S. Food and Drug Administration Requirements Document Implantable Medical-Grade Primary Lithium Batteries Office of Science and Engineering Laboratories, Division of Biophysics

1. Purpose This document states the requirements for the acquisition of 20 implantable medical-grade primary lithium batteries of Lithium Silver Vanadium Oxide, Carbon Monofluoride (Li/SVO-CFx) chemistry, in two configurations of 10 units each. The acquisition is for commercial supplies delivered to an FDA location.

2. Background The Food and Drug Administration (FDA), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) requires the acquisition of implantable-grade primary lithium batteries in two configurations for open-access regulatory science research. The research involves battery performance modeling, accelerated aging test method development, and system identification through discharge testing across a range of c-rates. The batteries will not be implanted in humans or animals. They will be used exclusively for laboratory testing and model parameterization.

3. Scope This acquisition is for the supply of the items identified in Section 4, in the quantity stated in Section 5, delivered and accepted per Sections 6 through 8.

This is a one-time purchase. The batteries will be used exclusively in the FDA laboratory setting to support internal research activities conducted by DBP within OSEL. The contractor's responsibility is limited to the supply of batteries that meet the specifications in Section 4 and the delivery of the associated product documentation.

Delivery coordination performed under Section 6 is incidental to the supply purchase and does not convert this action into a service contract.

4. Salient Characteristics and Minimum Specifications All items shall be new and unused. Items shall not be used, refurbished, reconditioned, remanufactured, previously opened, expired, or beyond the manufacturer's shelf-life dating at the time of delivery.

Salient characteristics and minimum specifications This requirement is described by salient characteristics. No manufacturer, brand, model, or manufacturer part number is specified, and none may be added to this document. Any product meeting every characteristic stated below is acceptable.

[Incomplete. The characteristics below are the only ones the program office supplied, and they were drawn from a single manufacturer's product data. They are not sufficient on their own to describe this need to more than one source. Complete this table before the requirement is solicited.] The supplies shall meet the following salient characteristics and minimum specifications:

Discharge profile: Capable of pulse discharge with a continuous background load of ≥ 95.3 kΩ, pulse amplitude ≥ 3.0 A, pulse duration of 10 seconds, and pulse frequency of up to once every 150 days. Cutoff voltage: 2.0 V Case material: Stainless steel. Case polarity: Negative. Pin/terminal material: Molybdenum or equivalent. Hermeticity: Hermetically sealed. Weight: ≤ 17 g. Volume: ≤ 6.5 cc. Dimensions (L × W × H): approximately 34.93 mm × 27.94 mm × 6.30 mm; shall not exceed these values by more than 5%. Storage temperature: –20°C to +60°C.

Capable of medium-rate sustained discharge with pulsing; background load of 9.53 kΩ, pulse amplitude of 20 mA, pulse duration of 900 seconds, and pulse frequency of up to once every 63 days. Cutoff voltage: 2.0 V minimum, with usable capacity of 4.80 Ah to 5.00 Ah between OCV-BOL and cutoff at 37°C.

Discharge profile: capable of medium-rate sustained discharge with pulsing; background load 9.53 kΩ, pulse amplitude 20 mA, pulse duration 900 seconds, pulse frequency up to once every 63 days; cutoff voltage 2.0 V minimum;

Case material: Titanium. Case polarity: Negative. Pin/terminal material: Titanium or equivalent. Hermeticity: Hermetically sealed. Weight: ≤ 22 g. Volume: ≤ 12.5 cc. Dimensions (L × W × H): approximately 46.48 mm × 31.70 mm × 9.63 mm; shall not exceed these values by more than 5%. operating temperature 37°C nominal. Storage temperature: –20°C to +60°C.

All 10 units of Item 1 (high-rate configuration) shall be from the same manufacturing lot. All 10 units of Item 2 (medium-rate configuration) shall be from the same manufacturing lot. At the time of delivery, each battery shall have a minimum of 2 years remaining from the date of manufacture.

5. Quantity and Deliverables The contractor shall furnish the following supplies in the quantities shown:

Quantity basis: one-time purchase. Total quantity is 20 batteries, 10 of each configuration.

Confirmed: the requirement is 10 individual batteries of the high-rate configuration and 10 individual batteries of the medium-rate configuration, 20 batteries total. "Cells" in the source document referred to the quantity of batteries, not the cell count within a battery.

6. Delivery Schedule and Delivery Terms FOB point: Destination.

Delivery location:

U.S. Food and Drug Administration Building 62, Room 1216 10903 New Hampshire Avenue Silver Spring, MD 20993 Delivery schedule: the contractor shall deliver all items in a single shipment within [Item 2 (medium-rate configuration): within 30 calendar days after award. Item 1 (high-rate configuration): within 180 calendar days after award. Split delivery is acceptable; the two configurations may be delivered separately. Latest acceptable delivery date for all items: March 31, 2028.

Delivery dates are firm. The contractor shall not extend a delivery date without prior written approval of the Contracting Officer.

The contractor shall provide advance shipping notification prior to shipment, including carrier, tracking information, and estimated delivery date.

The contractor shall coordinate delivery logistics with the Government point of contact identified in the resulting contract to confirm the delivery schedule, location, and any special handling instructions prior to shipment.

7. Packaging, Marking, and Shipping Supplies shall be packaged in accordance with standard commercial practice, sufficient to ensure arrival at destination undamaged and in usable condition. Each shipment shall be marked with the contract or order number, item description, quantity, and destination.

Batteries shall be packaged in accordance with applicable safety and transportation regulations for lithium-based medical-grade components, to prevent damage or degradation during shipment.

Standard commercial shipping practice for lithium primary cells is acceptable, including compliance with applicable DOT and IATA Dangerous Goods Regulations. Lot number and date of manufacture shall be marked on each package.

8. Inspection and Acceptance Inspection and acceptance shall be at destination. Consistent with RFO 46.202-1, the Government will rely on the contractor's existing quality assurance system for commercial products. Final acceptance is based on receipt of the correct items, in the correct quantity, conforming to the specifications in Section 4, in undamaged and usable condition, together with the product documentation required by Section 5.

The contractor shall replace, at no additional cost to the Government, any item found to be damaged, defective, or nonconforming to the specifications upon inspection at receipt. Replacement shall be made within 30 calendar days of notification.

9. Warranty Consistent with RFO 12.105(b), the Government will accept the contractor's standard commercial warranty to the maximum extent practicable.

10. Information Technology and Accessibility The batteries are passive supply items with no embedded or companion software, no connection to an FDA network, and no storage or transmission of data.

11. Period of Performance The period of performance begins upon award and continues through final delivery and acceptance of all items.

12. Points of Contact See contract for points of contact.