FDA Issues Draft Industry Guidance for Pulse Oximeters

On Monday, the Food and Drug Administration issued a draft guidance document regarding non-clinical and clinical performance testing, “Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations.” 

According to the FDA, “The recommendations are being made based in part on concerns that the accuracy of pulse oximeters can be affected by, among other factors, a person’s skin pigmentation.” American Thoracic Society members are continuing their involvement with federal agencies’ examination of ongoing concerns that pulse oximeters can produce discriminatory results based on a patient’s race, color, or national origin.

The FDA is requesting comments on the draft guidance by March 3, 2025 (Draft Guidance: Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations).

According to Indira Gurubhagavatula, MD, Perelman School of Medicine, University of Pennsylvania, "This is a tremendous first step in addressing the data that has emerged in recent decades indicating that the use of oximeters has led to serious disparities in clinical outcomes. The FDA guidance emphasizes the transparency of labeling, and the need for more inclusive validation studies. In the future, we would also benefit from real-world validation studies in clinical settings, in addition to healthy patients in controlled or idealized lab conditions. A focus on disseminating this information and mitigation strategies to key stakeholders would be helpful - including patients and clinicians. Information from oximeters is one data point in the larger clinical picture, and we need to keep this in mind and use our best clinical judgement when treating patients." 

TOBACCO CONTROL

Biden Expected to Issue Low Nicotine Tobacco Product Standard Proposed Rule

Before the end of the Biden administration, the FDA is expected to issue a proposed rule to lower nicotine concentration in tobacco products. While the scope of the proposed rule is not yet known, tobacco control advocates have long-urged the FDA to use its regulatory powers over tobacco products to lower the nicotine concentration levels in all tobacco products. 

“A standard that lowers nicotine concentration in all tobacco products has the potential to radically reduce the addictive potential of tobacco products,” says ATS Tobacco Action Committee chair Hasmeena Kathuria, MD. “A well-constructed policy could lead to reduce youth nicotine initiation and increased quite attempts in adults who smoke. The ATS urges the Biden administration to issue a proposed rule that covers all tobacco products - including e-cigarettes.”

CLEAN AIR

EPA Approves California Air Waivers

As the days of the Biden administration wind down, the Environmental Protection Agency has been moving quickly to grant last-minute approval of California waiver requests to address air pollution. The EPA recently granted waivers to allow California to implement zero-emissions policy for off-road vehicles, leaf blowers/lawn equipment, harbor watercraft, and refrigeration trucks. Earlier this month, the agency approved the California waiver request to phase out the sale of new combustion engines cars and trucks.

While only the state of California has the authority to request waivers from the EPA to implement air pollution controls more protective than the federal standards, other states are allowed to adopt the California standard. For previously granted waivers, several states have chosen to adopt the California standard.

It is highly unlikely that the Trump administration will try to revoke the recently approved California waivers. Further, several states are challenging in federal court the underlying law that grants California the ability to set more protective air quality emissions standards.

CLINICAL PRACTICE

ATS & CHEST Hold Webinar on Final Medicare Rule

Webinar on Medicare Coding and Billing
3 p.m. ET, Wednesday, Jan. 29

Have questions about Medicare telehealth policy? Want to understand how best to use the G2211 code? Experts from ATS and CHEST are hosting a webinar on the 2025 final Medicare rules to answer coding and billing questions. The webinar is free, but registration is required.