Devices
A 1/25-1/28 FDA inspection at Zimmer Biomet Holding’s manufacturing facility in Montreal, Canada, found multiple violations of the agency’s Quality System Regulation in the manufacturing of the iAssist knee system, Zimmer PSI shoulder system, Zimmer PSI knee system, and the Navitrack system. A just-released
Drugs
Mallinckrodt is asking FDA to designate Inomax (nitric oxide) 800 ppm for inhalation and its 510(k)-cleared specialized delivery system as a drug-device combination product. A 6/30 citizen petition says that Inomax is approved for use in treating neonates greater than 34 weeks gestational age suffering from
Devices
Newark, NJ-based Pharmaceutical Innovations has pleaded guilty to criminal charges and resolved a civil lawsuit surrounding its distribution of ultrasound gel contaminated with bacteria. The company pleaded guilty in Newark federal court to an information charging it with two misdemeanor counts of introducing adulterated medical devices into interstate commerce,
Devices
FDA has issued a guidance, Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, to describe relevant information that should be provided in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. The document says that electrically-
Devices
FDA has posted the transcripts (6/2 transcript and 6/3 transcript) from a 6/2-6/3 Circulatory System Devices Panel meeting that discussed and made recommendations about aerosolized transmission of nontuberculous mycobacteria (NTM) from contaminated water inside heater-cooler devices into the operating room environment and sterile field
Devices
FDA has approved a Concordia International PMA for its new Photofrin 630 Photodynamic therapy (PDT) laser. The cancer treatment combines a photosensitizing drug called Photofrin (porfimer sodium) with a specific type of light-energy laser to attack cancer cells, the company says. The device, which is designed to treat esophageal
Devices
FDA has cleared a JustRight Surgical 510(k) for specific use of its 3mm JustRight Vessel Sealing System in pediatric surgery. “JustRight Surgical is the first and only company to secure clearance from the FDA for an electrosurgical device to be used specifically for pediatric patients,” the company says. The
Drugs
FDA has released a draft guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees” that addresses the process for evaluating whether an advisory committee member has potentially disqualifying non-financial interests or relationships. It also describes FDA’s process for determining whether to
Drugs
Should FDA be allowed to accept gifts from any source on behalf of the United States? A new draft guidance on “Gifts to FDA: Evaluation and Acceptance” provides the process and principles the agency will use to implement this authority, recently delegated to it by HHS. The guidance is open
Devices
FDA has cleared a QT Vascular 510(k) for the Chocolate XD PTCA catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for improving myocardial perfusion, including in-stent restenosis. The device uses a “nitinol constraining structure that is mounted on a semi-compliant
FDA Policy/General
A panel of six former FDA commissioners, who combined have 32 years of FDA leadership experience, told an Aspen Institute/Atlantic magazine conference 6/25 they strongly believe the agency should be independent and not housed under Health and Human Services, and that it should operate under a model used
Devices
CDRH and the medical device industry are exploring the addition of more resources and performance goals under the next Medical Device User Fee Program to improve the Center’s Pre-Submission (Pre-Sub) process. In just-released user fee negotiation meeting minutes, FDA explained that the Pre-Sub consultation process
Devices
Medifirst Solutions has filed a 510(k) for its Time Machine TTML-8102000 Laser Thermal Therapeutic Device, and it has responded to a CDRH request for more information. The request was for electrical and safety test data, the company says, adding that a response from FDA is expected in a
Drugs
The American Society of Health-System Pharmacists (ASHP) has approved a policy that urges Congress to ban all direct-to-consumer (DTC) advertising of prescription drugs and medication-containing devices. The new policy, which was adopted earlier this month by the organization’s House of Delegates, is a reversal of
Devices
FDA says that adverse event reports submitted several years late by Medtronic for its Infuse bone graft did not provide any new information and did not warrant enforcement action. The agency statement is in a seven-page response to questions posed 4/12 by Sen. Al Franken (D-MN). The
Devices
FDA has cleared a Roche 510(k) for its Elecsys Brahms PCT (procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock. “PCT is a sepsis-specific biomarker associated with bacterial infection and PCT levels in blood can aid clinicians in assessing the risk of
Devices
Medical device consulting firm IMUA Services describes the five most common medical device wipeouts and how to avoid them. Using a surfing theme, the Carlsbad, CA, company identifies the mistakes as: * not conducting market research or not conducting enough research on who will use a product, how it is used,
Devices
The FDA Los Angeles District Office says that its evaluation of corrective actions taken by Advanced Sterilization Products, Irvine, CA, in response to a 3/12/10 Warning Letter indicates that the firm appears to have addressed the violations in the letter. “Future FDA inspections and regulatory activities will further
Drugs
As president Obama prepares to sign a bill into law that would reform how the government responds to Freedom of Information Act (FOIA) requests, FDA, for now, has lost a bid to withhold FOIA-requested internal records related to investigational drugs (ZMapp) used to treat Ebola victims. An Arizona federal
Devices
Writing in an FDA Voice blog post, CDRH director Jeffrey Shuren says that in the 40 years since Congress passed the Medical Device Amendments, what started out as a mom-and-pop industry “has transformed into a world of sophisticated software, algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures
Drugs
AdvaMed says it would like to better understand the relationship between an FDA draft guidance on human factor studies and related clinical study considerations in combination product design and development and a recently issued guidance on applying human factors and usability engineering to medical devices. Commenting on the new draft,
Drugs
FDA and the European Medicines Agency (EMA) have expanded their international collaboration by setting up a new forum or “cluster” on patient engagement. The working group will teleconference several times a year to share experiences and best practices on the way the two agencies involve patients in drug development, evaluation