Compliance In Focus

In Vitro Diagnostic (IVD) devices used in clinical trials are classified according to the risk that is involved based on the potential outcomes and impact if the test does not perform properly. The risk class (Class I, II, or III) determines the review pathway for regulatory assessment. If the device is classified as Class I or II, and if it is non-exempt, a premarket notification (510(k)) will be required for marketing. A 510(k) is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to a Premarket Approval (PMA).

The FDA issued the guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” on May 16th, 2016. Section 522 of the FD&C Act provides the FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or class III devices.

FDA defines the term laboratory developed test (LDT) as an in vitro diagnostic test (IVD) that is intended for clinical use and designed, manufactured and used within a single laboratory.  In 1976, the Medical Device Amendments (MDA) was enacted and amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a system for the regulation of medical devices intended for human use.  Although considered IVDs, the FDA chose to exercise enforcement discretion for LDTs with the justification that these tests were relatively simple, used only in the lab that developed the tests and were used for rare conditions. 

On May 6th, 2015 the FDA released a draft guidance on Leveraging Existing Clinical Data for Extrapolation of Pediatric Uses of Medical Devices.  This guidance expands on the information provided in the final Premarket Assessment of Pediatric Medical Devices guidance originally published in 2004 and updated in 2014. The FDA believes that leveraging relevant clinical data may lead to more devices being approved for pediatrics.  The guidance defines pediatric patients as 21 years or younger at the time of diagnosis or treatment.