FDA plans to exempt 30 types of diagnostic tests and radiology accessories from 510(k) review in one fell swoop, citing well-established safety and effectiveness profiles for the products.

The agency issued a draft guidance July 7 announcing the policy change impacting certain class I and II in vitro diagnostic and radiology devices. While it will require rulemaking to formally remove 510(k) mandates for the products, FDA plans to implement the change imminently by exercising enforcement discretion.

The exempted devices include common urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories, such as film cassettes, film processors and digitizers.

Over the years, the agency has cleared hundreds of such devices, from manufacturers such as Abbott, Roche, Beckman Coulter, Baxter and Masimo.

"The safety and effectiveness of these devices has been well demonstrated over the years," CDRH Director Jeffrey Shuren said in a same-day statement. "By addressing the risk level of these devices, the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers."

The draft guidance does not take effect until finalized, though FDA will not likely pursue actions against makers of these devices in the meantime, the agency told "The Gray Sheet."

Firms should determine how best to proceed until the guidance is finalized and can seek feedback from the agency in the interim, FDA explained.

Exemptions Fulfill 2007 User Fee Commitment

The exemptions fulfill a commitment the agency made about four years ago as part of the 2007 FDA user fee reauthorization to exempt some low-risk diagnostics from 510(k) review.

Device trade group AdvaMed presented FDA with a list of 30 device types to immediately down-classify more than a year ago, and has been pushing the agency to take action ever since. (See " Also see "AdvaMed Compiles List Of Tests That Should Be Exempt From FDA Review" - Medtech Insight, 15 February, 2010. " – "The Gray Sheet" Feb. 15, 2010.)

FDA's list differs substantially from the tests that AdvaMed proposed, though the agency notes that it plans to lighten the regulatory burden for additional IVD and radiology devices in the future.

"We applaud FDA’s use of risk-based regulatory criteria in this area to support an efficient regulatory process, foster innovation, help ensure timely patient access to new tests and focus review resources on higher risk tests,” said Andrew Fish, executive director of AdvaMedDx, in response to the draft guidance.

AdvaMed had envisioned the exemption of low-risk tests as a first step toward a broader risk-based regulatory framework for all diagnostic tests, including laboratory-developed test services. (See " Also see "AdvaMed Wants Across-The-Board Risk-Based Regulation For Diagnostics" - Medtech Insight, 6 April, 2009. " – "The Gray Sheet" April 6, 2009.)

According to FDA, the exemptions are unrelated to any decisions the agency may make regarding the regulation of laboratory-developed tests.

GMP, Labeling Requirements Remain

Manufacturers of the exempted devices will still have to comply with general pre-market controls, such as requirements for registration and listing, labeling, good manufacturing practices and adverse event reporting.

If a firm modifies an exempted device so that it differs substantially from the exempt generic device type, or if it intends to market the test for a new intended use, a 510(k) will be needed.

By Jessica Bylander

FDA: Farewell To 510(k) Review For 30 Types Of Low-Risk Diagnostic Tests

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