FDA Outlines Regulatory Path for Clinical Mass Spectrometry Devices
No protein or peptide mass spectrometry-based in vitro diagnostic device has received FDA clearance or approval, limiting clinical adoption. This perspective from FDA staff surveys the regulatory landscape, explains how guidance documents and standards factor into the review process, and calls for enhanced collaboration between the agency and the clinical MS community. The article signals FDA willingness to support development of MS-based diagnostics and provides a roadmap for navigating the regulatory pathway.
The original study
US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.
- Authors
- Lathrop JT, Jeffery DA, Shea YR, Scholl PF, Chan MM
- Journal
- Clinical chemistry
- Type
- Journal Article, Review
- PMID
- 26553791
Original abstract
Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry-based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry-based devices and enhance their entry into the clinic.