CABI U.S. Government Accountability Office · Audits audits
What GAO Found In 2016, the Food and Drug Administration (FDA) expanded its authority to oversee all tobacco products, including millions of e-cigarettes that were already on the market. In response, it received a surge of applications from manufacturers in 2020 for products seeking authorization to remain on the market legally. Specifically, it received over 25 million applications in 2020 and 2021, compared to just over 1 thousand applications in 2018 and 2019. This led to a backlog of applications. While FDA has since reviewed most of the applications submitted during this period, almost 132 thousand remained without a completed review as of December 31, 2025. (See figure.) Figure: FDA T.
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Food and Drug Administration | Rule | The Food and Drug Administration (FDA) is classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the flushing and storage solution for vascular autografts at room temperature. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' acces.
CABI U.S. Government Accountability Office · Audits audits
What GAO Found Under the Controlled Substances Act, substances that pose a risk of abuse and dependence are placed in categories—referred to as schedules. To carry out certain scheduling actions, the Drug Enforcement Administration (DEA) is required to obtain a scheduling recommendation from the Department of Health and Human Services (HHS) based on a scientific and medical evaluation from the Food and Drug Administration (FDA). Evaluations and recommendations from HHS or DEA are not required for substances scheduled through legislation. Of the 208 substances for which DEA took scheduling actions from 2020 through 2025, DEA considered HHS evaluations and recommendations for all 95 substance.
CABI U.S. Government Accountability Office · Audits audits
What GAO Found The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) administers the Third Party Review Program, a voluntary alternative review process for selected low-to-moderate risk medical devices, such as diagnostic ultrasound systems and surgical lasers. Under this program, which is intended to facilitate faster reviews, device sponsors can contract with FDA-accredited entities. These entities, known as Third Party Review Organizations (third parties), conduct the initial review of certain premarket applications, known as 510(k) submissions. These third party reviews occur prior to agency officials making the final decision about whether the devic.
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Food and Drug Administration | Rule | The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the..
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Food and Drug Administration | Rule | The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the medial knee implanted shock absorber. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
