FDA Policy/General
FDA Webview is posting the following Federal Register notices that published during our annual holiday break. 12/30/2021 Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Medical Device User Fee Cover Sheet and Device Facility User Fee Cover
FDA Policy/General
Federal Register notice: FDA is seeking comments on its contemplation of granting an exclusive patent license to Houston, TX-based Voxel Systems for the government-owned “System for Magnetic Resonance Spectroscopy of Brain Tissue for Pattern-Based Diagnostics.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in selecting nonvoting industry representatives to serve on certain CDRH Medical Devices Advisory Committee panels. The agency is also requesting nominations for nonvoting industry representatives to serve on certain device panels. To view the notice, click here.
FDA Policy/General
FDA Review is posting the following Federal Register notices that published during our annual holiday break. 12/30/2021 Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Medical Device User Fee Cover Sheet and Device Facility User Fee Cover
FDA Policy/General
BIOLOGICS FDA has approved an Ethicon BLA supplement for an expanded indication for Evarrest Fibrin Sealant Patch, indicated for stopping problematic bleeding during surgery. It now supports the product’s use as an adjunctive hemostat across a broad range of challenging patient types and surgical situations. DEVICES FDA has approved
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s Medical Devices Advisory Committee device panels. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance for industry entitled Inspection of Injectable Products for Visible Particulates. The document addresses the development and implementation of a risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective
FDA Policy/General
Federal Register notice: FDA is classifying the manual percutaneous surgical set assembled in the abdomen into medical device Class 2 (special controls). The action is based on a de novo classification request by Ethicon Endo-Surgery for its Percutaneous Surgical Set with 5mm or 10mm Attachments. The agency identified it
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The document is intended to provide clarity regarding references to the terms “device” and “counterfeit device.” To
FDA Policy/General
Federal Register notice: FDA is classifying the traumatic brain injury eye movement assessment aid into medical device Class 2 (special controls). The action is based on a de novo classification request by Oculogica for its EyeBox. The agency identified it as a prescription device that uses a patient’s tracked
FDA Policy/General
Federal Register notice: FDA is classifying the nonimplanted nerve stimulator for functional abdominal pain relief into Class 2 (special controls). The action is based on a de novo classification request for its IB-Stim. The agency has identified it as a device that stimulates nerves remotely from the source of
FDA Policy/General
Federal Register notice: FDA is classifying the endoscopic transhepatic venous access needle into Class 2 (special controls). The action is based on a de novo classification request by Cook Ireland for its EchoTip Insight Portosystemic Pressure Gradient Measuring System. The agency has identified it as a device that is inserted
FDA Policy/General
Federal Register notice: FDA is proposing to require PMAs for spinal spheres, a preamendment device, for use in intervertebral fusion procedures. The proposed PMA requirement is based on the device’s risks to health, such as the need for reoperation resulting from a failed spinal sphere device or component or
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Expanded Access to Investigational Drugs for Treatment Use” (OMB Control Number 0910-0814). The agency is revising the collection to account for reporting burdens attendant to other expanded access submissions, including commercial INDs that involve large groups
FDA Policy/General
FDA commissioner nominee Robert Califf says, if confirmed, “I’m going to be very aggressive in this area of medical misinformation (on social media) because one could argue that it is killing more people than any particular disease right now.” Califf’s hard line on social media promotions came in
FDA Policy/General
Federal Register notice: FDA has announced a 2/10/2022 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss and vote on an Innovent Biologics BLA for sintilimab for injection, indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with Stage
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of six ANDAs from multiple applicants after they notified the agency that the products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Expanded Access to Investigational Drugs for Treatment Use” (OMB Control Number 0910-0814). The agency is revising the collection to account for reporting burdens attendant to other expanded access submissions, including commercial INDs that involve large groups
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products. The document provides FDA’s current thinking on the necessary attributes of patients for enrollment in clinical trials, efficacy assessments, and safety assessments. To view the notice,
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population. The document addresses enrollment strategies, extrapolation of efficacy, safety database, and other considerations to help pediatric anti-infective drug development. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance for industry entitled Q3C (R8) Impurities: Guidance for Residual Solvents. The International Council for Harmonization document provides recommendations for permitted daily exposures (PDEs) for three additional residual solvents: 2-methyltetrahydrofuran, cyclopentylmethyl ether, and tert-butyl alcohol. The agency says the
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment. The document addresses FDA’s current recommendations regarding trial design, safety, and efficacy considerations. To view the notice, click here.