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FY 2005 ODE Annual Report - Part 4 - Major Program Initiatives

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As part of CDRH’s continuing efforts to assess performance, ODE led a cross-office pilot program during FY 05 to begin the assessment of the quality of reviews. The program began by looking at how the reviews of three scientific elements common to many Premarket submissions - biocompatibility, sterility/packaging, and statistics – were documented in FDA review memos. Three teams with expertise in each scientific area were assembled from across CDRH. Each team created a set of elements which they felt were critical for documentation or inclusion in a review related to that area. Those items were then used to assess the quality of review memos from randomly selected 510(k) and PMA submissions with final decisions. Each team was tasked with completing two rounds of review during FY 05 – each round consisting of 25 510(k) and 2 PMAs.

For 510(k)s, significant quality issues were found in 28% of biocompatibility reviews and 78% of sterility reviews. For the PMAs, no major issues were noted for the biocompatibility reviews but inadequacies in sterility reviews were noted in all. Statistical review memos were evaluated in 4 PMAs and were deemed adequate in all the reviews.

The findings of the pilot program will be used to implement educational and procedural changes during FY 06 with the intent of improving the quality of the reviews for these elements. The three groups will continue to perform regular assessments of submissions to monitor changes. In addition, a fourth team will begin assessing the quality of software reviews in FY 06.  


January 2005 brought a major shift in the program related to post-approval studies (PAS) ordered as conditions of approval (CoA) for PMAs. Traditionally, this program had been the responsibility of ODE. Beginning on January 1, ODE formally began consulting epidemiologists in the Office of Surveillance and Biometrics (OSB) for novel or first-of-a-kind PMAs at the time of submission. The epidemiologists have been tasked with reviewing the PMA data with an emphasis on potential clinical issues that would be appropriate for post-market evaluation. Early involvement of the epidemiologists allows time to begin interaction with the other review team members and the sponsor to identify the issues as well as to begin designing an appropriate PAS protocol. In FY 05, epidemiologists were consulted and included on the review team for 11 new PMA submissions and made several presentations to Advisory Panels. For PMAs which are not first-of-a-kind submissions, ODE will maintain primary responsibility for working with the sponsor in formulating an appropriate PAS. Also beginning in January of 2005, OSB assumed responsibility for tracking all PAS ordered as a CoA.

An electronic database which will allow CDRH to notify sponsors if and when PAS reports are overdue was created and became operational. OSB will also post and update the status of PAS requirements on the public website. OSB will now be responsible for reviewing PAS interim/final reports and issuing the appropriate letters with consults from ODE staff and reviewers as needed. These efforts will continue in FY 06 and the Center believes they will result in PAS which are well designed, better tracked, and more likely to be performed and completed.  


Over the past year, ODE has continued to pursue development of new IT systems for improved tracking and monitoring of submissions. We have begun to critically review our current systems and to consider the infrastructure needs required to move toward electronic submissions.

Electronic Copies

ODE encourages all manufacturers to submit electronic copies along with the paper submission whenever possible. Electronic copies will save resources for the FDA and will provide additional navigational tools for the review staff who will be working with the document. In addition, the electronic copy may serve as one of the required paper copies. Instructions for submitting submissions in electronic form can be found on the CDRH home page at the address HowtoMarketYourDevice/PremarketSubmissions/ucm134508.htm.

Improved Systems For Document Tracking And Archiving 

Numerous enhancements were made to information systems used by ODE during FY 2005. Image2000 (an archival document management system) received a new eReviewer interface that allows for viewing My Favorites, folder contents, folder summary information and a document content all at the same time. The Enhanced Center Information Retrieval System (eCIRS), a web-based retrieval system, gained added functionality and enhanced data access and reporting. The Center Tracking System (CTS), formerly DTS, has new features, including a system for tracking Condition of Approval studies, a mechanism for the development of new product codes, and the ability to calculate MDUFMA cycle days for PMAs, modular PMAs and amendments.

Work is underway on an improved system for tracking consulting reviews across CDRH, called the eConsult system, which will be accessed through the existing CTS. We have also recognized the need to optimize and modernize CDRH premarket administrative processes and the supporting IT architecture and systems. A Center-wide group has been working with a contractor to address current inefficiencies in the databases used in the processing of Premarket Applications and will be initially developing the reporting and linking capabilities before phasing in other capabilities, including post market administrative processes .

Improved Communication and Interaction Tools For PMA Review Teams 

In FY 05, ODE continued to pilot the use of eRoom, web-based software to facilitate communication and interactions among team members in the review of PMAs. The software was first used with all new PMAs and PMA supplements for specific branches in ODE and with other specific PMAs from non-pilot branches. A software template and the rules for using the software were developed by a cross-center team including representatives from ODE and several of the offices involved in the review of PMAs. The results of the pilot were assessed and a decision was made to expand the use of the software to encompass all original PMAs and panel track PMA supplements received from FY 06 onward. The benefits of the program include improved communication among review team members and improved consistency by providing a central storage location for documents. It is hoped that the software will lead to improved timeliness of reviews. The eRoom software is also used by other working groups and teams within ODE for collaboration, document creation, and document posting in a shared work space.

Hardware Upgrades 

Using Center funding, ODE replaced 40% of its desktop computers with laptop/docking station computers as part of a Center plan to update computers on a regular basis. In addition, ODE improved its infrastructure by ordering new network printers and scanners.


Combination products, consisting of devices and drugs or devices and biologics, continued to be a focus of effort for ODE. In FY 05, we interacted with the FDA Office of Combination Products, the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) on the review of many combination device-drug and device-biologic products.

In FY 05, ODE reviewed 20 Requests for Designation (RFDs), 13 for device-drug combinations and 7 for device-biologic combinations. CDRH was given the lead for 10 of these. We also reviewed and acted on 109 premarket applications for combination products. Our device expertise was called upon frequently by our sister centers and we performed 194 consulting reviews.

Our staff is involved in many intercenter collaborative working groups, including:

  • Cardiovascular Products Working Group
  • Cartilage Repair Group
  • DHHS Joint Working Group on Telemedicine
  • FDA RFID Team
  • Interagency CWD Decontamination Working Group
  • Interagency Oncology Task Force
  • Orthopedic Indications Working Group
  • Patient Reported Outcomes Intercenter Group
  • Rheumatology Intercenter Working Group
  • Tissue Engineering Working Group (FDA, NIH, NIST, NASA, DOE) 
  • Tissue Policy Team
  • Tissue Reference Group
  • Wound Healing Clinical Working Group
  • Wound Care Solutions Working Group

ODE Device Guidance Documents

In FY 05, ODE issued 14 guidance documents, 5 Level 1 and 9 Level 2, which are listed below. Among the 14, 5 are Special Controls guidance. In addition to consulting with all of the offices across the Center on many issues addressed in guidance, one of the 14 was developed in collaboration with Office of In Vitro Diagnostics and another in collaboration with the Office of Compliance. These guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: which provides easy access to the latest information and operating policies and procedures. They may also be obtained from the Division of Small Manufacturers International and Consumer Assistance (DSMICA, HFZ-200). To contact DSMICA, call 800-638-2041; fax 240-276-3103; Email or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307.)

Document Name Off/Div/Br Date
Guidance for Industry and FDA Staff - Class II Special Controls Document: Oral Rinse to Reduce the Adhesion of Dental Plaque ODE/DAGID/DEDB 09/20/2005
Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff OIVD
Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) ODE/DRARD/OGDB 07/27/2005
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff CBER
Dental Bone Grafting Material Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff ODE/DAGID/DEDB 04/28/2005
Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)] ODE/DAGID/GHDB 04/15/2005
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software ODE
Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff ODE/DCD/PVDB
Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff ODE/DRARD/OGDB
Class II Special Controls Guidance Document: External Penile Rigidity Devices ODE/DRARD/ULDB 12/28/2004
Class II Special Controls Guidance document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information - Guidance for Industry and FDA Staff ODE/DAGID/GHDB 12/10/2004
Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff ODE/DGRND/REDB

Reclassification Petitions

Any interested person may submit a petition to the agency for reclassification of a device, e.g., from class III to class II, or class II to class I. Additionally, the agency on its own initiative, may follow procedures to reclassify a generic type of device. There are five sections under the Federal Food, Drug, and Cosmetic Act by which we may reclassify a device, Section 513(e), 513(f) 514(b), 515(b) and 520(l) depending on the status of the device type, such as new device types found to be not substantially equivalent or transitional devices formerly regulated as drugs. The reclassification petition needs to contain sufficient information to allow FDA to determine that the proposed classification can provide reasonable assurance of safety and effectiveness. Reclassification petitions and their final decisions are put on public display at the Dockets Management Branch.

Final Classification Actions

  • Published a final rule classifying external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA is also exempting these devices from premarket notification requirements. [Effective January 27, 2005].

Final Reclassification Actions

  • Published a final rule in the Federal Register on December 29, 2004 reclassifying two embolization device types from class III into class II (special controls). The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain type of tumors, and arteriovenous malformations. The neurovascular embolization device (previously the artificial embolization device) is intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. [Effective January 28, 2005].
  • Published a final rule in the Federal Register on April 28,2005 reclassifying tricalcium phosphate (TCP) granules for dental bone repair from class III into class II (special controls), classifying into class II (special controls) other bone grafting material for dental indications, and revising the classification name and identification of the device type. Bone grafting materials that contain a drug that is a therapeutic biologic will remain in class III and continue to require a premarket approval application. The classification identification includes materials such as hydroxyapatite, tricalcium phosphate, polylactic and ployglycolic acids or collagen. [Effective May 31, 2005].


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