Devicemakers responding to unsolicited requests for off-label product information are urged to keep conversations private and specific to the requester’s inquiry, according to a new FDA draft guidance.
Concerns about the future of the FDA’s 510(k) process appear to have been put to rest with the year-end issuance of a draft guidance on evaluating substantial equivalence in 510(k)s.
Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product CodesDecember 30, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments
Since the May 28, 1976 Medical Device Amendments were passed, the Classification Regulation Panels (21 CFR 862-892) have been the basis for the Center for Devices and Radiological Health?s (CDRH) Classification Product Code structure and organization.
Ventilator may stop ventilating and result in life-threatening injury or death.
Reason for Recall: The AVEA ventilator can develop a failure where the ventilator activates a false Extended High Ppeak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer...
Additional concentration of liquid acetaminophen marketed for â€œinfantsâ€ (160 mg/5 mL) is now available.
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation.
St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead InsulationDecember 21, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments
Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, including death.
Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First DoseDecember 20, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments
Patients with MS should not stop taking Gilenya without talking to their healthcare professional.
Guidance for Industry and Food and Drug Administration Staff - Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology DevicesDecember 20, 2011 3:30 am | by U.S. Food & Drug Administration | News | Comments
This document is intended to describe FDA?s intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under 21 CFR Part 807, Subpart E. FDA intends to propose the...
WASHINGTON, D.C. â€“ Representatives Edward J. Markey (D-Mass.), Diana DeGette (D-Colo.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) today sent a letter to the Commissioner of the Food and Drug Administration (FDA) raising concerns about flaws...
Labeling, Approval Order, and Summary of Safety and Effectiveness for AtriCure Synergy Ablation System (P100046).
The AtriCure Synergy Ablation System is used to destroy (ablate) heart tissue that is beating abnormally. It includes the Synergy Ablation Clamp, a handheld surgical device that destroys the heart tissue that is grasped between the clamp?s jaws during...
A negative devices advisory panel opinion, based on inconsistencies in clinical trials, may jeopardize a hoped-for buy-in by St. Jude Medical for the CardioMEMS monitoring device for heart failure.
Devicemakers no longer need to meet a Jan. 1 Sunshine Act deadline for reporting payments to doctors and hospitals.
Draft Guidance for Industry and Food and Drug Administration Staff - Evaluation of Sex Differences in Medical Device Clinical StudiesDecember 16, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
The purpose of this guidance is to outline the Center for Devices and Radiological Health?s (CDRH) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The intent is to improve the quality and...
Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the...December 14, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments
Conflicting results from different studies makes it premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.
Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information.
This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation request to the U.S. Food and Drug Administration (FDA or Agency) Office of Orphan Products Development (OOPD). It is...
- Products and Medical Procedures Implants and Prosthetics Current Page is:Gastric Banding - Gastric BandingDecember 13, 2011 7:31 am | by U.S. Food & Drug Administration | News | Comments
Gastric banding is a surgical procedure to reduce the size of the stomach for weight loss. In this procedure, a silicone band is placed around the upper portion of the stomach to create a small pouch.
The U.S. Supreme Court appears unconvinced after oral arguments on Prometheus Laboratories’ thiopurine metabolites test patent, but one legal expert predicts the high court will uphold an appeals court decision in favor of Prometheus.
For some devices, laboratory testing and computer modeling may work better than clinical trials, William Maisel, deputy center director of CDRH, said.
ELYRIA, Ohio--(BUSINESS WIRE)--Invacare Corporation today announced that the U.S. Food and Drug Administration (FDA) has requested that the Company negotiate and agree to a consent decree of injunction relating to previously disclosed inspectional observations...
LifeScience Alley and FDA's Devices Center Sign Memorandum of Understanding to Advance Regulatory ScienceDecember 9, 2011 5:33 am | News | Comments
MINNEAPOLIS--(BUSINESS WIRE)--LifeScience Alley announced today that it has signed a memorandum of understanding (MOU) with the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The MOU formalizes interactions that have been occurring