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The first draft guidance lays out two options sponsors can use to demonstrate accuracy, i.e., “insignificant risk of erroneous result,” of in vitro diagnostic tests for purposes of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The second draft guidance aims to make the dual CLIA waiver and Section 510(k) clearance pathway for certain Class I and Class II IVD devices created in 2012 less burdensome.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:

NEW FDA APPROVALS

New CE Marks & Global Certifications
Notable European CE certifications:

NEW CE CERTIFICATIONS

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.