Regulatory
MDUFMA Minutes: FDA Would Go With Total-Time Review Clock
October 7, 2011 2:31 pm | by U.S. Food & Drug Administration | News | CommentsThe 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.
FDA-CMS Parallel Review
October 7, 2011 6:30 am | by U.S. Food & Drug Administration | News | CommentsThe 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.
Uprizing 2.0: Recall - Undeclared Drug Ingredient: Synthetic Steroid
October 6, 2011 12:30 pm | by U.S. Food & Drug Administration | News | CommentsProduct marketed as testosterone booster contains superdrol, a synthetic steroid. Use of synthetic anabolic steroids may cause serious long-term adverse health consequences.
Minutes From Negotiation Meeting on MDUFA III Reauthorization, August 24, 2011
October 6, 2011 6:30 am | by U.S. Food & Drug Administration | News | CommentsThe 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...
Network of Experts- Expert Utilization Standard Operating Procedure (DRAFT)
October 4, 2011 8:31 am | by U.S. Food & Drug Administration | News | CommentsThe 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
Network of Experts- Expert Enrollment Standard Operating Procedure (DRAFT)
October 4, 2011 8:30 am | by U.S. Food & Drug Administration | News | CommentsAn SOP on the selection and enrolment of organizations for the Center for Devices and Radiological Health (CDRH) Network of Experts.
Information on Denture Adhesives
October 3, 2011 9:31 am | by U.S. Food & Drug Administration | News | CommentsDenture 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...
Class I Medical Device Recall: Lee Medical International Inc., Custom Dialysis Trays / Kits
October 3, 2011 4:30 am | by U.S. Food & Drug Administration | News | CommentsReason 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...
Devicemaker: EU Path a Band-Aid, No Cure for Frustrations With FDA
September 30, 2011 1:30 pm | by U.S. Food & Drug Administration | News | CommentsTaking a device to Europe to gain quicker market access is a short-term fix, not the solution to maintaining innovation.
Sebelius, Shuren: New Policies Not Enough, Fees Must Rise
September 30, 2011 1:30 pm | by U.S. Food & Drug Administration | News | CommentsCDRH 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 | CommentsThe 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.
Documents the Center for Devices and Radiological Health is Considering for Development (FY12)
September 29, 2011 6:30 am | by U.S. Food & Drug Administration | News | CommentsThis 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...
PMA Final Decisions for July 2011
September 28, 2011 9:30 am | by U.S. Food & Drug Administration | News | CommentsThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 2011.
PMA Final Decisions for August 2011
September 28, 2011 9:30 am | by U.S. Food & Drug Administration | News | CommentsThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2011.
FDA Shows Big-Company Bias in Inspections, Reviews: Devicemaker
September 23, 2011 2:31 pm | by U.S. Food & Drug Administration | News | CommentsSOUTH 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.
510(k) Guidance Fallout, Review Clock Revamp Discussed in User Fee Talks
September 23, 2011 2:30 pm | by U.S. Food & Drug Administration | News | CommentsA 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.
Minutes From Stakeholder Meeting on MDUFA III Reauthorization, August 18, 2011
September 21, 2011 5:31 am | by U.S. Food & Drug Administration | News | CommentsTo provide a status update of the ongoing MDUFA III negotiations.
Minutes From Negotiation Meeting on MDUFA III Reauthorization, August 9, 2011
September 21, 2011 5:30 am | by U.S. Food & Drug Administration | News | CommentsTo 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.
Public Workshop ? Magnetic Resonance Imaging Safety, October 25-26, 2011
September 20, 2011 7:30 am | by U.S. Food & Drug Administration | News | CommentsFDA 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
Boston Sci, Medtronic at Odds With IRS Over Transfer Tax
September 16, 2011 2:31 pm | by U.S. Food & Drug Administration | News | CommentsDevicemakers 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.
FDA: Do European Doctors Prefer FDA Approval Process to EC & #8217;s?
September 16, 2011 2:30 pm | by U.S. Food & Drug Administration | News | CommentsThe 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).
Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error
September 16, 2011 11:30 am | by U.S. Food & Drug Administration | News | CommentsDaily regimen may be incorrect and could leave women without adequate contraception.
H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination
September 16, 2011 8:30 am | by U.S. Food & Drug Administration | News | CommentsUPDATED 09/16/2011. Lee Medical International Custom Dialysis Trays/Kits recalled. Use of contaminated Povidone Prep Pads could lead to life-threatening infections.
Class I Medical Device Recall: Lee Medical International Inc., Custom Dialysis Trays/Kits
September 16, 2011 7:30 am | by U.S. Food & Drug Administration | News | CommentsReason 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...
Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms
September 15, 2011 11:30 am | by U.S. Food & Drug Administration | News | CommentsAvoid 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.
