FDA ombud: Industry complaints up 45 percent in 2009

FDA logo

The Food & Drug Administration’s Center for Devices and Radiological Health saw a dramatic, 45 percent increase in complaints last year, logging a record high of 133 in 2009.

In total, the agency received 250 contacts during the year, a 41 percent increase from the previous high-water mark of 177 in 2007, according to the agency’s annual ombudsman’s report. The 2009 tally is also a record high for the agency, which first opened its ombudsman office in 2000.

The complaints, made primarily by industry, seemed to center on the agency’s Office of Device Evaluation, which accounted for about 54 percent of the contacts. The FDA’s compliance office came in a distant second, logging about 17 percent of total complaints.

Not surprisingly, the most complaints revolved around the watchdog’s embattled 510(k) program, which accounted for 17 percent of all complaints. Some of the beefs listed by industry included data/testing requirements and lack of timeliness. There were also complaints about CDRH employees and various policies and procedures.

  2009 2008 2007 2006 2005 2004 2003 2002 2001
Calls 250 170 177 120 114 125 120 53 72
Complaints 133 92 85 56 72 77 82 27 51
Disputes 53 31 55 40 25 39 38 26 21

RSS From Medical Design & Outsourcing

  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]
  • MasterControl’s CEO talks EQMS software and new partnerships
    MasterControl offers a quality and compliance software that helps device companies speed time to market and improve their bottom lines. Under Jon’s leadership, the company has blossomed into a market leader and has a unique corporate culture that fosters growth, excellence and quality. In this podcast, MasterControl’s CEO, Jon Beckstrand, will discuss electronic quality management […]
  • BIT Group launches white label IVD solutions
    BIT Group has launched a product line of customizable IVD white label instruments. During recent years, BIT has invested capital and resources developing customizable, ready-to-use IVD systems to address a growing demand. “The IVD market is challenging for our clients,” said Marius Balger, CEO at BIT. “OEM’s must adhere to a growing number of evolving IVD […]
  • Toshiba expands line-up of ARM Cortex-M-based microcontrollers
    Toshiba announced that it has enhanced its current “TX Family” of ARM core-based microcontrollers and started to develop three series of microcontrollers, “TXZ0 series,” “TXZ3 series” and “TXZ4 series,” as part of the “TXZTM Family.” The TXZTM Family is a new collection of flash microcontrollers that support low-power consumption and high-speed operation for IoT and M2M […]
  • Parker Hannifin consolidates, layoffs ahead
    Parker Hannifin plans to consolidate a number of internal divisions, close 2 facilities and expand its Mexican operations, according to an internally distributed letter from Andy Ross, Parker’s engineered materials group president. The company has confirmed the letter was authentic, but has not disclosed how many employees will be affected by the new plans or […]
  • 3-phase current transducer from PEM delivers all-in-one convenience
    The new RCTrms 3-ph current transducer from Power Electronic Measurements (PEM) delivers a convenient, safe and accurate solution for measuring current in three phases. It features a thin, clip-around, flexible sensor coil and provides accurate true rms measurement with 4-20 mA or 0-5 V output, enabling simple installation with PLC’s, SCADA systems or automation equipment. […]
  • Safety alert: Recall on two IV solutions from Baxter
    Baxter International announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital and user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to […]

Leave a Reply