FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary

On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs:

1. No Mandatory Lab Coding of Tests
Laboratory coding is voluntary, not mandatory, according to the guidance. However, the FDA recommends that test makers use the Observation Identifiers Names and Codes (LOINC) for coding IVD tests.

2. No Mandatory Lab Coding of Devices
Similarly, the FDA is recommending but not requiring inclusion of LOINC codes for IVD tests in labeling of medical devices. The agency does not intend to perform premarket review of the LOINC codes that manufacturers provide to labs or other users.

3. LOINC Codes Must Be for Test's Approved Indications
According to the guidance document, the LOINC codes the device manufacturer provides should be consistent with the particular IVD test's FDA-cleared or approved indications for use. Dissemination of LOINC codes suggesting an unapproved or uncleared indication may be evidence that the device is adulterated and/or misbranded.

4. LOINC Code Distribution Format Neither Required nor Recommended
While declining to recommend a specific format for distribution, the agency "acknowledges" that LOINC codes may be displayed as simple text in a table format, or in structured formats such as Java Script Object Notification (JSON) or Extensible Markup Language (XML). However, the FDA "strongly encourages" use of an FDA-recognized consensus standard, e.g., the LOINC transmission document for IVDs (LIVD) standard, for communicating or disseminating the LOINC codes provided by manufacturers or others to labs or other end users.

FDA Revises Zika Blood Testing Guidance
On July 6, the FDA issued revised guidance for testing of donated blood for Zika virus. Punchline: After initially recommending universal nucleic acid testing of individual blood donation units, the agency indicated that it will now allow pooled testing which the guidance described as more cost effective and "less burdensome" for blood establishments. However, the guidance continued, the need for individual testing may be triggered "when certain threshold conditions are present" such as an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area.

The final guidance still requires blood establishments to test all donated whole blood and blood components for Zika virus using a nucleic acid test. Since 2016 two assays have been approved under investigational new drug applications—the Cobas Zika (Roche Molecular Systems, Inc.) and the Procleix Zika Virus Assay (Grifols Diagnostic Solutions, Inc.). In May of this year, the FDA approved an additional claim for Roche's Cobas Zika test for pooled testing of blood or plasma donations.

New FDA Approvals
A trio of Breakthrough Device designations headline the month in FDA approvals. Here are the key approvals announced during the period (which runs from the third week in June through the third week in July):

NEW FDA APPROVALS

New CE Marks & Global Certifications
Notable European CE certifications:

NEW CE CERTIFICATIONS IN EUROPE

Other international clearances announced during the period: