Regulatory
Breast Cancer Ultrasound Device Gets Favorable Panel Recommendation
April 13, 2012 2:32 pm | by U.S. Food & Drug Administration | News | CommentsAn FDA advisory panel unanimously recommended approval of a new tool for detecting breast cancer, but advised against Class I status for a preamendment device used for the same purpose.
U.S. Should Bring Developing Nations on Board to Tackle Import Problems: Report
April 13, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsThe FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report. The recommendation is one...
PMA Final Decisions for February 2012
April 13, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 2012.
Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots
April 10, 2012 10:31 am | by U.S. Food & Drug Administration | News | CommentsWomen should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.
CDRH Learn (New Module - Factors to Consider When Making Benefit-Risk Determinations in Medical Device PMA and De Novo Classifications)
April 10, 2012 6:30 am | by U.S. Food & Drug Administration | News | CommentsThis guidance document was developed to identify and clarify the factors FDA considers when making benefit-risk assessments in PMA applications, and de novo classification petitions for medical devices.
CDRH Misses MedSun Goals, Cites Success in MDR Reviews, Other Areas
April 6, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsRecent agency data show CDRH making slow but steady progress toward several strategic goals — but missing the mark on the Medical Product Safety Network (MedSun) initiative.
Senators Set June Deadline for Sunshine Implementation
April 6, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsThe senators who co-authored the Physician Payments Sunshine Act are trying once more to exercise their legislative oversight — this time setting a June deadline for overdue implementation of the rules.
Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information
April 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsTitle II of the Food and Drug Administration Amendments Act of 2007 (FDAAA), also termed the Medical Device User Fee Amendments of 2007, P.L. 110-85, extends FDA?s authority to collect medical device user fees by establishing a fee for ?a request for...
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmet...
April 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsThe purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug,
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (June 21, 2012)
April 4, 2012 9:31 pm | by U.S. Food & Drug Administration | News | CommentsThis notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform
April 4, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsMay result in reduction of blood flow from the pump, pump/graft thrombosis, or perforation of the outflow graft.
Class I Medical Device Recall: Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)
April 4, 2012 9:31 am | by U.S. Food & Drug Administration | News | CommentsDetachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow...
Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient
April 3, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsThe counterfeit product may have resulted in patients not receiving needed therapy.
Wingspan Stent & #8217;s Benefits Don & #8217;t Justify Risks, Panel Concludes
March 30, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsStryker’s Wingspan stent could be yanked from the market if the FDA heeds March 23 recommendations of its Neurological Devices Panel.
Shuren Predicts CDRH & #8216;Death Spiral & #8217; Absent Timely MDUFA Passage
March 30, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsCDRH would move into a “death spiral” if Medical Device User Fee Act (MDUFA) legislation is not reauthorized this summer, director Jeffrey Shuren warned at a Senate Health, Education, Labor & Pensions (HELP) committee hearing Thursday.
Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms
March 28, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsRevised drug label clarifying dosing and warning recommendations.
Guidance: Class II Special Controls Guidance Document: Full Field Digital Mammography System
March 27, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsFDA has developed this guidance as the special control to support classification of full-field digital...
New FDA guidance on considerations used in device approval, de novo decisions
March 27, 2012 7:30 am | by U.S. Food & Drug Administration | News | CommentsFDA has published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits...
Pilot Would Reduce Audit Frequency Using Harmonized Regulations
March 23, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsStarting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance.
U.S. Supreme Court Prometheus Ruling May Limit Future Research
March 23, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsLast week’s U.S. Supreme Court decision on the patent eligibility of a diagnostic could have ramifications for in vitro diagnostic (IVD) devicemakers, limiting investment in novel tests because of uncertainty about what is and is not patentable, a U.S. patent attorney tells D&DL.
Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates
March 23, 2012 10:30 am | by U.S. Food & Drug Administration | News | CommentsRisk of embolization/infarction to organs and potential organ complications.
CDRH Learn (New Module - ISO 13485:2003 Voluntary Audit Report Submission Pilot Program)
March 23, 2012 8:31 am | by U.S. Food & Drug Administration | News | CommentsThis presentation explains FDA's new voluntary audit report submission pilot program, which is based on ISO 13485, an international standard utilized in the medical-device sector in many places around the world.
Markey Joined by Victim, Patient Advocate in Call for Closure of Dangerous Medical Device Loophole
March 22, 2012 11:27 am | News | CommentsWASHINGTON, D.C. – Today, with tens of thousands of patients suffering grave health effects as a result of defective medical devices, Congressman Edward J. Markey (D-Mass.) released a comprehensive new report titled “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected...
Markey To Call for Closure of Dangerous Medical Device Loophole
March 22, 2012 7:17 am | News | CommentsWASHINGTON, D.C. – Today, Congressman Edward J. Markey (D-Mass.), a senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), will be joined by a patient, surgeon and health advocate at the release of a new report...
Brilliant Blue G: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases
March 19, 2012 6:30 am | by U.S. Food & Drug Administration | News | CommentsReports of eye infections in patients who were given Brilliant Blue G during eye surgeries.
