FDA Recommends 510(k) Changes
New FDA recommendations for 510(k) approval could affect analytical instrument companies, as they expand into the clinical diagnostics marketplace. The FDA Center for Devices and Radiological Health this month released a new evaluation of the 510(k) approval process.
A 510(k) approval is required for the sale of “medical devices,” which include clinical chemistry and clinical toxicology devices and immunological and microbiology devices. “Premarket notification” applies to the introduction of a medical device that is equivalent to one already on the market. “Premarket approval” is required for medical devices that are being introduced for the first time and require clinical trials to demonstrate that they are safe and effective.
Certain medical devices are exempt from premarket approval requirements. Laboratory-developed tests (LDTs), which are developed and used by a single lab, have traditionally fallen into such a category. In general, LDTs have included genetic tests. However, recent actions by the FDA, most notably its issuance of notification letters to several companies regarding LDTs, including Illumina (see IBO 6/30/10) and Sequenom, has indicated changes in the FDA’s approach (see IBO 7/31/10).
Medical devices are classified according to the level of control they require. Class I devices are exempt from premarket notification and some Class II devices are exempt. Class III devices may be reclassified through the “de novo” process if it is novel but low risk.
The FDA’s new preliminary recommendations address concerns about the effectiveness of the 510(k) process. The report recommends clarification of the 510(k) review process and the expectations for 510(k) content. The report also proposes the development of a more efficient de novo classification process and a new Class IIb category based on postmarket information. The report also addresses mechanisms by which the FDA can obtain more information about submissions.