The U.S. Food and Drug Administration (FDA) has released a new draft guidance [TR1] providing recommendations for non-clinical and clinical performance testing, labeling, and premarket submission requirements for pulse oximeters intended for medical purposes. The draft guidance aims to address concerns, particularly about the impact of skin pigmentation on the measurement accuracy of pulse oximeters. It is tailored to describe the recommended information to be included in 510(k) submissions. However, recommendations provided may also be applicable to devices reviewed via the De Novo classification or Premarket Approval pathways.
Especially noteworthy for previously 510(k) cleared devices, the FDA recommends that the manufacturers gather clinical data to evaluate their pulse oximeters for non-disparate performance and submit this data in a new 510(k) submission. The clinical data may be derived through, for example, controlled desaturation laboratory studies or real-world data. Special consideration should be given to devices intended for pediatric populations younger than 12 years of age.
The draft guidance emphasizes the importance of early and continuous interaction with the FDA. NSF can help to plan and prepare strategies to comply with the related requirements and may also support with the preparation of relevant submission documentation including Q-Submissions to the FDA to clarify the need for additional testing, clinical data or updates to the labelling.
[TR1]Bitte beim Posten auf die Verlinkung achten. ☺️
