FDA Corrects Statutory Error on Informal Hearings Linked to Banned Devices
The US Food and Drug Administration (FDA) announced it is amending its regulations to correctly reference the statutory and regulatory provisions that provide an opportunity for an informal hearing in connection with a banned device.
The correction of the error, which is taking effect immediately, will further align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause, FDA says.
FDA spokeswoman Deborah Kotz told Focus: “The Safe Medical Devices Act (SMDA) passed by Congress in 1990 amended the Federal Food, Drug and Cosmetic Act to narrow the requirement regarding when FDA must offer informal hearings from one that required FDA to offer an informal hearing for all proposed bans to one that only requires FDA to offer one for proposed bans with a special effective date.
“FDA’s device ban regulations at 21 CFR part 895 have been amended to reflect this change. The technical amendment that published yesterday corrects an error in 21 CFR part 16 in the lists of statutory and regulatory provisions that require informal hearings to be offered so that these lists reference the correct statutory and regulatory provisions pertaining to device bans,” she added.
The change will not have any impact on the availability of informal hearings.
“FDA decided to make these changes because a stakeholder recently brought the inconsistency to our attention,” Kotz explained. “However, these changes only update a list of citations; they do not add or detract from hearing availability, which was altered in 1990 under SMDA.”