FY 2005 OIVD Annual Report - Part 4 - Other Program Activities
Patient Safety and Product Quality
The integration of post-market monitoring of product quality and safety in OIVD is continuing to evolve to better protect public health. OIVD continues to apply a risk-based approach for management of inspection and enforcement actions so that our efforts will have the maximum effect on the public health. OIVD is responsible for evaluating and monitoring compliance and surveillance programs covering regulated industry; evaluating industry quality systems, quality control, and testing programs to assure compliance with regulations; and reviewing and monitoring advertising and promotion of IVDs to determine compliance with regulations. We interact with Agency field offices and other Agency staff relating to legal actions, case development, and product recalls. In FY 2005, there were 7 Class I Recalls, 3 Warning Letters and no Seizures. A brief description of each action is listed below. In addition, there were 9,605 MDR Reports for FY 2005.
Class 1 Recalls on the web: http://www.fda.gov/Safety/Recalls/default.htm
|Applicant||Device Name||Date Initiated|
|Ortho-Clinical Diagnostics||VITROS® Immunodiagnostic HBsAg Confirmatory Kit||12/15/05|
|bioMérieux, Inc.||VeriCal® Calibrator Sets||8/19/05|
|Abbott||Blood Glucose Meters||6/7/05|
|LifeScan, Inc.||Blood Glucose Meters||4/11/05|
|bioMérieux, Inc.||Simplastin® HTF Tissue Reagent||3/7/05|
|MicroScan||MicroScan® Rapid Pos Inoculum Broth||2/7/05|
|Becton Dickinson||ProbeTec™ ET Urine Processing Kit||1/10/05|
Warnings Letters on the web: http://www.fda.gov/foi/warning.htm
|BioImagene, Inc.||5/25/05||Lacks Approved Premarket Application/Adulterated|
|Access Genetics||8/1/05||Lacks Premarket Notification Clearance/Adulterated/Misbranded|
|Tepnel Diagnostics, Ltd.||8/26/05||Lacks Premarket Approval Application/ Adulterated|
Integrity Application Integrity Program
Under the Application Integrity Program (AIP), OIVD has considered cases concerning the integrity of data submitted to the agency in premarket applications. During FY 05, we placed one application on Integrity Hold and removed the Integrity Hold on another application.
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The categorization of commercially marketed in vitro diagnostic tests under CLIA has been the responsibility of the FDA since January 31, 2000. FDA performs the CLIA complexity categorization that includes the assignment of these test systems to one of three CLIA regulatory categories (waived, moderate and high) based upon their level of complexity. A CLIA waiver determination may be granted to: 1) the nine generic tests waived by the regulation, 42 CFR 493.15(c); 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met; and 3) test systems cleared by the FDA for home use.
During FY 05, OIVD performed categorizations on a total of 1962 tests including 429 waived, 1288 moderate, and 245 high tests. The number of waived tests increased more than two-fold from FY 04. CLIA categorizations for previous fiscal years are shown in the graph below, Figure 12.
Figure 12. CLIA Categorizations
An on-line, searchable CLIA database is available that contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000, and tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date. More information on the CLIA program can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ IVDRegulatoryAssistance/ucm124105.htm.
OIVD continues to be involved in several resource-intense initiatives related to national bioterrorism preparedness and response. OIVD established liaisons to collaborate with other government agencies and the military to prepare for and assume regulatory responsibilities applicable to medical devices that are critical to bioterrorism preparedness efforts. ODE/OIVD is currently developing guidance and procedures for timely premarket review and approval of these devices.
OIVD cleared two devices for the detection of Bacillus anthracis: the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System (an anthrax immunoassay) sponsored by Idaho Technology and a Gamma Phage Lysis assay specific for Bacillus anthracis manufactured by the Army Medical Research Institute of Infectious Diseases (USAMRIID) and distributed by CDC. OIVD participated in inter-agency meetings related to "Evaluation of Pre-Screening Technologies" for possible biological agents/threats, on the TOPOFF 3 exercise, and in BioShield initiatives such as the Emergency Use Authorization Working Group lead by HHS and the development of the Emergency Use Authorization of Medical Products Draft Guidance.
OIVD’s bioterrorism preparedness activities also formed the building blocks for the office in helping the government prepare for pandemic flu and other potential health emergencies as this becomes an area of increasing importance.
Turbo 510(k) (eSubmission)
In an effort to standardize the 510(k) submission, reduce premarket review effort and develop a better premarket/post market balance more in line with the TPLC regulatory concept, OIVD continued developing the Turbo 510(k) eSubmission program. An eSubmission guides industry to submit only scientifically and administratively complete applications, making it easier to meet MDUFMA goals. In addition, this program preserves institutional memory, enhances knowledge management and increases consistency of decision-making regarding product clearances.
Turbo 510(k) was piloted in FY 04 and significant gains were made in the enhancement of the program through direct feedback from the industry volunteers who submitted their 510(k) using the eSubmission.
Premarket Notification (510(k)) Decision Summary Templates
In an effort to provide stakeholders with the scientific / regulatory basis for FDA’s decisions and to be consistent with CDRH’s center-wide “Knowledge Management” and “Transparency” initiatives, OIVD developed and implemented the use of a standardized Premarket Decision Summary Template across all the OIVD divisions.
The Premarket Decision Summary Template summarizes the basis on which an in vitro diagnostic device was cleared under a 510(k) submission. OIVD implemented the use of this standardized premarket Decision Summary Template in August 1, 2003. The decision summaries have been continuously posted on the OIVD webpage and the public has full access to them through the 510(k) database. CDRH has been receiving positive feedback from regulated industry, the professional community, and consumers because the decision summaries have given them the ability to make informed decisions regarding the use of these in vitro diagnostic devices.
Advisory Panel Activities
In FY 05, an Immunology Devices panel meeting was held. The panel reviewed the PMA, made recommendations, and voted on an application for a laboratory assay designed to measure levels of neural thread protein in urine specimens from patients presenting with cognitive complaints or other signs and symptoms of suspected Alzheimer’s disease. The panel unanimously recommended that the PMA be found not approvable. Refer to the ODE annual Report for more information on advisory panels.