The Medical Device Business Journal — Medical Device News & Articles | MassDevice
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD March 2012
DEVICE: OASYS SURGICAL LIGHT CONTROLLER
OASYS HEALTHCARE 510(k) NO: K112133(TRADITIONAL)
ATTN: TANYA M O'BRIEN PHONE NO : 813 645 2855
962 ALLEGRO LANE SE DECISION MADE: 01-MAR-12
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FD TENS 2070
FUJI DYNAMICS LTD 510(k) NO: K111654(TRADITIONAL)
MASSDEVICE ON CALL — The FDA last week issued final guidance on agency and medical device industry protocol for addressing requests for information and applicable user fees.
Certain requests for classified information, dubbed 513(g) requests, are unilaterally subject to user fees without exception for pediatric devices or for requests from state or federal agencies, according to the guidance.
By Stewart Eisenhart, Emergo Group
Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls.
Former Medtronic (NYSE:MDT) CEO Bill Hawkins will serve as the first chairman of a new private-public partnership aimed at improving development and testing of medical devices.
The partnership includes the Minnesota med-tech community, the FDA’s Center for Devices & Radiological Health and the University of Minnesota to establish a regulatory science center in the North Star State.
MASSDEVICE ON CALL — Incoming Johnson & Johnson (NYSE:JNJ) CEO Alex Gorsky will have a full plate when he takes the corner office in April.
Amid ongoing recalls and related lawsuits, Gorsky has his work cut out for him in restoring consumer faith in health care giant.
The FDA’s neurological devices panel will review clinical data from trials of Stryker’s (NYSE:SYK) Wingspan brain stent system next month, aiming to address harsh criticisms and public petitions urging the agency to recall the device.
The panel plans to consider pre-market and post-market data about the device, including the Gateway PTA balloon catheter and stent delivery system, to address concerns that Wingspan may lead to heightened risk of stroke or death.
Sen. Chuck Grassley (R-Iowa) launched an investigation into whistleblowers’ claims that the FDA systematically persecuted and spied on employees who voiced concerns over certain medical devices cleared for the U.S. market.
MASSDEVICE ON CALL — FDA medical device review chief Jeffrey Shuren laid out efforts at addressing device makers’ concerns as he toured life sciences hubs in California.
Stops on his tour included a visit to NuVasive (NSDQ:NUVA) in San Diego, whose CEO Alex Lukianov had announced just days prior that FDA delays were costing the company about $70 million each year.
The FDA released 3 additional draft guidances to close out 2011, bringing its total to 9 guidances for the year.
The new drafts outline the agency’s protocol for medical device product codes, detail the process for appealing a decision made by the Centers for Devices & Radiological Health, and provide advice on how a drug or device maker should handle requests for information on off-label use for products,
The FDA made it official with LifeScience Alley, a Minnesota-based medical device lobbying group, signing a memorandum of understanding on the continued development of best practices in regulatory science.
| Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
| Mizuho Orthopedic Systems Inc | Oct-27-2011 | Modular Table System – Mizuho OSI Modular Table System;Product Usage: For use in orthopaedic surgery to provide support to a patient. |
