This is the list of guidance documents CDRH is considering for development this year (2012). CDRH plans to update this list every year. CDRH invites interested persons to submit comments on any or all of the guidance documents on the list to docket...
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 2011.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2011.
SOUTH SAN FRANCISCO, Calif. – The FDA may be giving large companies preferential treatment when conducting inspections and reviewing device submissions, an executive with a smaller company alleged during a CDRH town hall meeting.
A possible tripling of the CDRH review workload and a revamped regulatory review clock were main topics of separate Medical Device User Fee and Modernization Act (MDUFMA) reauthorization meetings involving the FDA and device industry.
To provide a status update of the ongoing MDUFA III negotiations.
To discuss potential workload and performance impacts of the Institute of Medicine?s report on 510(k)s and the draft guidance on 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.
FDA is announcing a public workshop entitled: Magnetic Resonance Resonance Imaging (MRI) Safety Public Workshop. The purpose of the public workshop is to discuss factors affecting the safe use of magnetic resonance imaging MRI and approaches to mitigate
Devicemakers like Boston Scientific and Medtronic may be finding themselves caught in the gears of federal revenue raising as the IRS ramps up transfer pricing audits.
The FDA wants to know how heavily European physicians rely on clinical trial data used to get U.S. approval in decisions to prescribe devices, according to a request for proposals (RFP).
Daily regimen may be incorrect and could leave women without adequate contraception.
UPDATED 09/16/2011. Lee Medical International Custom Dialysis Trays/Kits recalled. Use of contaminated Povidone Prep Pads could lead to life-threatening infections.
Reason for Recall: These custom dialysis trays/kits contain PVP Prep Pads that were recalled by H & P Industries. The pads may not be sterile. Patients receiving hemodialysis who use the pads may be at potential risk for serious or life threatening...
Avoid use of ondansetron in patients with congenital long QT syndrome, and monitor those with electrolyte abnormalities, CHF, bradyarrhythmias, or those taking concomitant medications that prolong the QT interval.
Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery PerformanceSeptember 12, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments
Potential for reduced battery performance can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms.
Advisory Committee Notice of Meeting: October 13, 2011 - Circulatory System Devices Panel of the Medical Devices Advisory CommitteeSeptember 11, 2011 9:30 pm | by U.S. Food & Drug Administration | News | Comments
Confirmed Scheduled Advisory Meetings
Devicemakers may flee overseas if the U.S. implements a recently enacted tax on prescription devices, AdvaMed says. The nation could lose thousands of device industry jobs and see demand shrink for products whose cost rises as a result of the excise tax, according to a report the trade...
FDA device regulators would get marginally more money in fiscal 2012 than in fiscal 2011, but nearly $7 million less than the agency sought.
Meeting Materials for the Obstetrics and Gynecology Devices Panel Meeting held on September 8-9, 2011September 9, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
The Obstetrics and Gynecology Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics...
The purpose of this follow up letter is to provide specific recommendations to facilitate the FDA import entry review process for medical and non-medical radiation-emitting electronic products.
Tumor Necrosis Factor-alpha (TNF & alpha;) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and ListeriaSeptember 7, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments
Patients treated with TNF? blockers are at increased risk for developing serious infections.
MECHANICAL ventilators provide essential respiratory support to critically ill patients in healthcare facilities, in homes, and during patient transport. Providing care to patients requiring mechanical ventilation can be challenging due to factors such...
PMAs for silicone gel-filled breast implants should be revoked if manufacturers don’t improve post-approval study follow-up, consumer advocates and a former FDA official told an agency advisory panel.
Devicemakers and the FDA remain divided on the terms of Medical Device User Fee and Modernization Act (MDUFMA) reauthorization as the deadline approaches for resolving differences.
CDRH Learn (Spanish): Overview of Regulatory Requirements: Medical Devices - Video, slides, transcriptSeptember 2, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments
Online training though video presentation, slide presentation on medical device regulatory requirements