Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs

The COVID-19 pandemic has exposed how the FDA’s makeshift premarket control over laboratory developed tests (LDTs) stifles innovation and keeps desperately needed new tests from reaching the market. It has also accelerated the efforts to impose a modern, more transparent and workable system not only for the rest of the pandemic but the long-term future.

How FDA Regulates LDTs

Lab tests weren’t included in the original legislation that created the FDA and current regulatory system of medical drug and device regulation. So, the agency has relied on its powers to regulate devices. Accordingly, LDTs must obtain premarket approval through the 510(k) pathway for medical devices. In addition to challenging the FDA’s authority over LDTs, the lab industry has long objected to the agency’s practice of skirting the regulatory process and relying on guidance, website statements and other informal issuances to make regulatory policy.

The HHS Decision

As the crisis has deepened, the agency has found itself in the position of backing away from its hands-on approach and has allowed laboratories and test makers greater discretion in launching LDTs detecting the SARS-CoV-2 virus. And now a new Administration pronouncement carries that policy to a new and significant level. On Aug. 19, HHS announced that the FDA will no longer be able to regulate by informal decrees but will have to go through the customary notice and comment rulemaking process required for new regulations to regulate LDTs.

One result of the HHS decision, which is part of the Administration’s broader policy to cut government regulation over business, is that labs will now be able to offer LDTs for SARS-CoV-2 without going through the FDA’s Emergency Use Authorization (EUA) process. “Those with an active EUA to use an LDT to detect the virus causing COVID-19 or its antibodies are unaffected by this announcement,” HHS added.

The VALID Act

The unexpected HHS announcement is the most recent in a series of efforts to rein in FDA regulation over LDTs. After several aborted attempts, last March, legislators in the U.S. House of Representatives and Senate reintroduced the Verifying Accurate Leading-edge IVCT Development Act (VALID) creating a new system for FDA review of in vitro clinical tests (IVCTs). VALID would establish a risk-based framework, with high-risk tests, like novel assays, required to go through premarket review; lower-risk tests could go to market after passing through technological certification. Key features of VALID:

• Establishment of a technology certification program for lower-risk tests;
• Requirement that high-risk tests undergo premarket review to verify analytical and clinical validity;
• Authority of the FDA to require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency; and
• Creation of a new system to allow hospitals and laboratories to submit their tests electronically to the FDA for approval.

The law would also grandfather in existing LDTs being used clinically.

Here are some of the key FDA EUAs and clearances announced in August:

New FDA Emergency Use Authorizations (EUAs) & Approvals

New CE Marks & Global Certifications
Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Other international clearances announced during the period: