The FDA has plans to revamp its clock and calendar for calculating how long device reviews take and would like to allocate user fee funds to internal training.
The FDA and CMS have established a pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations.
Product marketed as testosterone booster contains superdrol, a synthetic steroid. Use of synthetic anabolic steroids may cause serious long-term adverse health consequences.
The Agency provided a response and counter-proposal to Industry's July 26, 2011 proposal that the Agency viewed as being responsive to Industry?s requests and objectives. The Agency indicated its goal of achieving several objectives that are held in...
The purpose of the Network of Experts is to provide staff at the Center for Devices and Radiological Health (CDRH, Center) with rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise
An SOP on the selection and enrolment of organizations for the Center for Devices and Radiological Health (CDRH) Network of Experts.
Denture adhesives are pastes, powders or adhesive pads that may be placed in/on dentures to help them stay in place. Sometimes denture adhesives contain zinc to enhance adhesion...
Reason for Recall: These custom dialysis trays/kits contain alcohol swabs and prep pads that were recalled by H & P Industries. The alcohol swabs and prep pads may not be sterile. Patients receiving hemodialysis who use the swabs and pads may be at...
Taking a device to Europe to gain quicker market access is a short-term fix, not the solution to maintaining innovation.
CDRH Director Jeffrey Shuren and HHS Secretary Kathleen Sebelius agree that devicemakers have to pay more in user fees.
Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation)September 30, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments
The purpose of this document is to provide guidance on the process for the submission and review of petitions under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the de novo classification process.
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.