FDA Watch: Off-Label Marketing Rule Put Back on Ice & Extra Comment Time for CLIA Waiver Proposals

For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing, i.e., promotion of medical products for additional uses not spelled out in the original approval. The rule was slated to take effect but the agency wants more time to consider its effect, according to the official FDA announcement. The delay is a clear win for the pharma and device industry which claims that the proposed rule chills innovation to the detriment of public health.

FDA Extends Comment Period for CLIA Device Waivers
Much more popular with industry is the FDA’s proposed loosening of the rules governing the granting of CLIA waivers for in vitro diagnostic (IVD) medical devices. The agency has announced that it is pushing back to March 30 the deadline for commenting on a pair of draft guidances.

The first draft guidance lays out two options sponsors can use to demonstrate accuracy, i.e., "insignificant risk of erroneous result," of in vitro diagnostic tests for purposes of obtaining a CLIA waiver:

  • Demonstrate accuracy of the test when performed by trained operators as part of the marketing submission via comparison to a traceable calibration (or reference) method and then leveraging the data in combination with a new study to demonstrate agreement between results of the test performed by untrained and trained operator in the waiver by application submission; or
  • Where the sponsor chooses to demonstrate the test’s substantial equivalence or safety and efficacy when performed by trained operators in the marketing application without demonstrating accuracy via comparison to a traceable calibration (or reference) method, "the sponsor [may] demonstrate accuracy of the test when performed by untrained operators through direct comparison to a traceable calibration method (or reference method), or other comparative method performed in a laboratory setting by trained operators in the waiver application."

The second draft guidance aims to make the dual CLIA waiver and Section 510(k) clearance pathway for certain Class I and Class II IVD devices created in 2012 less burdensome. Among other things, the guidance recommends that manufacturers include as part of a dual submission:

  • A device description and determination that the device is "simple";
  • A risk analysis for the device;
  • A description of its failure-alert and fail-safe mechanisms;
  • Results of flex, analytical, comparison and reproducibility studies; and
  • Proposed device labelling.

New FDA Approvals
Here’s a rundown of the key new FDA approvals announced in mid-December through mid-January:


Manufacturer(s) Product(s)
Myriad Genetics Expanded indication of BRACAnalysis CDx test for identifying breast cancer patients with germline BRCA mutations likely to benefit from AstraZeneca’s PARP inhibitor Lynparza (olaparib)
Cepheid Approval and CLIA waiver for Xpert Xpress Flu molecular test used in near-patient settings to detect both A and B strains of influenza from nasopharyngeal or nasal swabs
BioMérieux Approval of Vitek 2 AST-GN test was cleared for use with Amikacin drug
BioMérieux Approval of Vitek 2 AST-GN test was cleared for use with Ceftazidime/Avibactam drug
Siemens Healthineers and Sysmex Approval of Sysmex Automated Blood Coagulation Analyzer CS-2500
Siemens Healthineers Approval of Advia Chemistry Enzymatic Hemoglobin A1c test
Beckman Coulter Diagnostics Approval of MicroScan Dried Gram-Negative MIC /Combo Panels with CeftazidimeAvibactam assay
Beckman Coulter Diagnostics Approval of MicroScan Dried Gram-Negative MIC /Combo Panels with Ciprofloxacin-S assay
Beckman Coulter Diagnostics Approval of MicroScan Dried Gram-Negative MIC /Combo Panels with Ceftolozane/Taxobactam assay
Alere (now part of Abbott) Approval of BinaxNOW Influenza A & B Card 2 and Alere Reader assay for detecting influenza A and B nucleoprotein antigens in nasopharyngeal swab and nasal swab specimens
Euroimmun (now part of PerkinElmer) Approval of Anti-Borrelia burgdorferi US Euroline-WB kit for qualitative determination of IgM class antibodies against Borrelia burgdorferi in human serum and plasma
Fujirebio Diagnostics Approval of Lumipulse G BRAHMS PCT test for quantitative determination of procalcitonin in human serum and plasma
Inova Diagnostics Approval of Quanta Flash Calprotectin assay for detection of fecal calprotectin in stool samples to run on Lumipulse G system
MolecularMD Approval of MRDx BCR-ABL molecular test to help physicians determine if Philadelphia chromosomepositive chronic myeloid leukemia can stop treatment with Novartis’ drug Tasigna (nilotinib)

New CE Marks & Global Certifications
Notable European CE certifications:


Manufacturer(s) Product(s)
Asuragen Approval of QuantideX qPCR BCR-ABL IS Kit for identifying major (e13a2, e14a2) fusions for use on Roche Cobas z 480 Analyzer
Asuragen Approval of QuantideX qPCR BCR-ABL minor kit for identifying minor (e1a2) BCR-ABL fusion transcripts in patients with chronic myeloid leukemia for use on Roche Cobas z 480 Analyzer
Roche Approval of Ventana MMR IHC Panel for diagnosing colorectal cancer
Abbott Approval of Alinity h-series system for hematology testing, which integrates the Alinity hq standalone hematology analyzer with its Alinity hs slide maker-and-stainer module
Becton Dickinson and Check-Points Health Approval of BD MAX Check-Points CPO assay, PCR-based NGS screening test for antibiotic-resistant carbapenemase-producing organisms
Hologic Approval of Brevera breast biopsy system with CorLumina imaging technology
Accelerate Diagnostics Approval of Accelerate Pheno system for detecting severe bacterial pneumonia infections
Stat-Dx Approval of DiagCore syndromic molecular testing platform
Stat-Dx Approval of Respiratory Panel 1for detecting 21 common bacteria and viruses that can cause respiratory infections from nasopharyngeal specimens

Other key international clearances during the period included:

  • World Health Organization granting of prequalification status to Hologic’s CE-marked Aptima HIV-1 Quant Dx, the first HIV-1 viral load assay with a dual claim for both diagnosis and treatment monitoring;
  • Approval of Vela Diagnostics’ Sentosa SX101 instrument in Taiwan;
  • Approval of IGene Laboratory’s iGene noninvasive prenatal test in Singapore;
  • Approval for DermTech licensee DermTech Canada to market the company’s pigmented lesions assay and noninvasive biopsy kit for melanoma detection in Canada.

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