Apr 20, 2021

The US Food and Drug Administration (FDA) published a ruling in the Federal Register on April 19, adjusting the identifications of medical software in classification regulations to exclude functions that no longer fall under the scope of the agency’s regulatory authority. The ruling is effective immediately from the date of publication.

Background: medical software and the 21st Century Cures Act

The need for this FDA ruling extends back to the 2016 passage of the 21st Century Cures Act, which introduced wide-ranging efforts to streamline market access for manufacturers of pharmaceutical products and medical devices, at times by curtailing the agency’s authority. One of the law’s provisions was to identify types of medical software that posed minimal risk to patients and, absent a specific safety concern, did not require FDA regulatory oversight. The five categories of software listed were:

  • Software for administrative support of healthcare facilities
  • “Healthy lifestyle” software that provides no diagnostic, prevention, or treatment function
  • Electronic patient records
  • Software for transferring, storing, or displaying medical device or clinical laboratory test data but that does not support interpretation or analyze clinical data
  • Software to acquire, process or analyze medical images from an IVD or signal acquisition system

The 21st Century Cures Act amended the language of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to remove said software functions from the definition of a medical device. The purpose of the recent FDA ruling is to ensure that the stated scope of the agency’s regulatory authority corresponds to what is currently delineated in the FD&C Act.

FDA removes excluded non-device software functions from classification regulations

The FDA cites the fourth category in the list above (software that transfers, stores, reformats, or displays clinical or device data without interpreting or analyzing it) as the most pertinent to the ruling. The regulatory status of the device hardware is not affected by the 21st Cures Act, so none of the classifications for the device types are changing.

The table below, taken from the ruling as published in the Federal Register, identifies the eight classification regulations that are impacted by the ruling. In all cases, the identifications have changed to remove excluded non-device software functions. Specific details on the changes are available in the full text of the FDA ruling.

Classification regulation (21 CFR)

Device type (existing product code(s))

862.2100

Calculator/Data Processing Module for Clinical Use (JQP, NVV).

862.1350

Continuous Glucose Monitor Secondary Display (PJT, PKU).

866.4750

Automated Indirect Immunofluorescence Microscope and Software-Assisted System (PIV).

880.6310

Medical Device Data System (OUG).

884.2730

Home Uterine Activity Monitor (LQK, MOH).

892.2010

Medical Image Storage Device (LMB, NFF).

892.2020

Medical Image Communications Device (NFG, LMD).

892.2050

Picture Archiving and Communications System (QIH, OMJ, NWE, PGY, OEB, QKB, PZO, NFJ, LLZ).

Source: US Food and Drug Administration

More resources on US FDA medical device and software regulations at Emergo by UL:

  • SaMD secure development lifecycle management support
  • US FDA 510(k) consulting for medical device, IVD, and software companies
  • Cyber regulatory support for medical devices and software
  • Webinar: Mapping cybersecurity standards to FDA guidance

Author

  • Timothy Herr

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