CDRH Learn Spanish Module

CDRHNew: Get e-mail updates RSS News Feed JavaScript is required to view this page. Article source: http://www.fda.gov/cdrh/newpg.html

Draft Guidance for Industry and Food and Drug Administration Staff

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: January 3, 2012 You should submit comments and suggestions regarding this draft document within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets [...]

Questions and Answers: FDA approves a class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines

On December 28th, the U.S. Food and Drug Administration (FDA) approved a single, shared system Risk Evaluation and Mitigation Strategy (REMS) for the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines. This REMS, called the TIRF REMS Access program, consists of a restricted distribution program to reduce the risk of misuse, abuse, addiction, and [...]

PMA Final Decisions for November 2011

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the “Approval letter and Summary of Safety and Effectiveness” is being added to this listing for each PMA. The PMA number will appear as a link if this document [...]

SOP: Management of Review Staff Changes During the Review of a Premarket Submission

1. Purpose This document describes Standard Operating Procedures (SOP) for CDRH’s management of review staff changes during the review of a premarket submission.1 2. Background CDRH strives to provide timely and consistent feedback and guidance to submitters. On occasion, during the review of a premarket submission, staff turnover necessitates the reassignment of a premarket review [...]

Draft Guidance for Industry and Food and Drug Administration Staff

Draft Guidance This guidance document is being distributed for comment purposes only. Document issued on: December 27, 2011 You should submit comments and suggestions regarding this draft document within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management [...]

Draft Guidance for Industry and Food and Drug Administration Staff

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.Document issued on: December 27, 2011 You should submit comments and suggestions regarding this draft document within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management [...]

Class I Medical Device Recall: CareFusion AVEA Ventilator

Recall Class: Class I Date Recall Initiated: September 8, 2011 Product: AVEA ventilators manufactured between March 1, 2009 and June 30, 2011. Use: The AVEA ventilator is intended for continuous breathing support for the care of neonatal through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care institutions. [...]

CareFusion AVEA Ventilator: Recall

[Posted 12/23/2011] AUDIENCE: Risk Manager, Anesthesiology, Critical Care ISSUE: FDA notified healthcare professionals of a class I recall of CareFusion AVEA Ventilators. The AVEA ventilator can develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury [...]

FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants

Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Additional Background Information   Safety Announcement [12-22-2012] The U.S. Food and Drug Administration (FDA) is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available at local stores. Until now, liquid acetaminophen marketed for infants was [...]