Item 7.01 Regulation FD Disclosure.

In fourth quarter 2019, Baxter International Inc. (the "Company" or "Baxter") submitted three 510(k) applications for its new Novum IQ infusion platform to the U.S. Food & Drug Administration ("FDA"). The applications cover the NOVUM IQ Large Volume Pump (the "NOVUM LVP"), the NOVUM IQ Syringe Pump and Dose IQ Safety Software. Following discussions with FDA the week of September 28, 2020, the Company elected to withdraw its applications on October 2, 2020 in advance of the deadline for FDA's completion of its review of the applications in accordance with the Medical Device User Fee Amendments. The Company did so in the interest of being able to close out open items on the applications and is working collaboratively with FDA to update its submissions with additional technical information and documentation. The Company currently intends to submit its updated 510(k)s no later than December 31, 2020.

Baxter remains confident in the fundamentals of the Novum IQ platform. To date, Health Canada has approved the NOVUM LVP for distribution in Canada.

Baxter plans to provide additional details regarding the anticipated timing and nature of these updated submissions on its upcoming earnings call for third quarter 2020, currently scheduled for October 29, 2020.

This Form 8-K may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to statements regarding the anticipated timing of the Company's resubmission of the application referenced above to FDA and its view as to the design, safety and effectiveness of the Novum IQ infusion platform. Use of the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "seeks," "intends," "evaluates," "pursues," "anticipates," "continues," "designs," "impacts," "affects," "forecasts," "target," "outlook," "initiative," "objective," "designed," "priorities," "goal," or the negative of those words or other similar expressions is intended to identify forward-looking statements that represent our current judgment about possible future events. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: future discussions with and actions of FDA and other risks identified in Baxter's most recent filings on Forms 10-K and 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

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