Food and Drug Administration

You might be thinking, that’s an odd title: obviously FDA’s breakthrough device designation is helpful.  However, after looking at the data, my conclusion is that I would avoid the breakthrough device designation for any product that qualifies for the 510(k) process.  The process is likely not helpful for such devices.

[Update – August 3, 2022: See the bottom of this post.]

Continue Reading Unpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the agency does okay, but they also sometimes may miss their own guideline by a wide margin.  I use the word “may” there because the FDA data set is inadequate to support a firm conclusion.  I’ll explain more about that below, but this is another case of FDA releasing incomplete data that frustrates data analytics.

Continue Reading Unpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA

Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.

CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.

Continue Reading CMS Issues Guidance on COVID-19 Testing in the Workplace

On September 15, 2021, CMS published a proposed rule that would repeal a final rule that created an expedited pathway for Medicare coverage of breakthrough devices and established formal criteria for applying the “reasonable and necessary” standard for coverage in Section 1862(a)(1)(A) of the Social Security Act, which has been the basic standard for coverage since the inception of the Medicare program.[1]  CMS has set a short period for comments, and interested parties must submit comments by October 15, 2021.

The new proposed rule reflects a significant policy change.  Where the initial rule focused on expanding access to new innovations, the current approach focuses more on Medicare program goals and outcomes data.
Continue Reading CMS Proposes to Reverse Course and Repeal Its Final Rule Expediting Medicare Coverage of Breakthrough Devices and Defining the Medicare “Reasonable and Necessary” Coverage Standard

On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco