Office of Device Evaluation Annual Report Fiscal Year 2006 and Fiscal Year 2007 | Prev.: Advances in Patient Care | Home: Preface / Table of Contents | Next: Magnet for Excellence |
In the following sections, each of the ODE review Divisions reports on some of the combined 2006/2007 important accomplishments.
DAGID Staff Subject Matter Experts on Emergency Preparedness and Influenza
DAGID staff expertise about personal protective devices and seasonal and pandemic influenza has been sought for review of subject-matter documents from other agencies, such as, CDC and OSHA. In addition, DAGID staff represents CDRH on several Department, Agency-wide committees as well as CDRH committees. A sampling of the committees DAGID staff served on is below:
DAGID launches the “Reviewer Round Table” Series
In March 2006, DAGID launched an exciting new program called “Reviewer Round Table.” The program is an opportunity to informally have a broad discussion about devices that are “simple or complicated, unique or challenging, or just one that presents its own unusual “issues.” Bimonthly one of DAGID’s branches, Anesthesiology and Respiratory Devices (ARDB) Branch, General Hospital Devices Branch (GHDB), Infection Control Devices Branch (INCB), or Dental Devices Branch (DEDB), is responsible for presenting an interesting case study about a device. The case study can focus on pre-market approval issues, post-market follow-up, or special or specific unique device qualities. The presentations have included discussions about the challenges related to device reviews, and decisions concerning approval or clearing of devices. By bringing these discussions to the staff of the entire Division the sharing of information is expanded beyond the immediate review team. This allows for added input, often leading to an enhancement of the considerations necessary for added value to the review process. It also minimizes the “silo” effect and encompasses a broader scope of ideas.
Interagency Working Group
The Infection Control Devices Branch (INCB) works closely with the Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA) through quarterly teleconferences. The purposes of the meetings are to keep all three agencies apprised of public health issues related specifically to disinfection and sterilization, disease outbreaks including avian influenza and possible pandemic influenza, other disease outbreaks, such as, norovirus gastroenteritis and Clostridium difficile infections throughout the community and in unrecognized risk groups, and other high profile and potentially dangerous public health problems. Some of the issues recently addressed include surgical N95 respirators and surgical masks.
Single Use Devices Post -Market Issues (PMI) Action Teams
Infection Control Review Staff participated in the Post-Market Issues (PMI) Action Team for Reprocessing of Single Use Devices (SUDs). The overall goal is to improve the accuracy of medical device adverse event reporting to the Agency, and to enhance the Agency’s data gathering and collating abilities with regard to reprocessed SUDs. The efforts of the Action Team will allow for improvements in speed and accuracy of data recovery, and to enable better integration of premarket activities and post-market research. These efforts have already facilitated rapid responses to a Congressional inquiry. For a summary of recent activities in the field of Reprocessing of SUDs, see http://www.fda.gov/cdrh/reuse/.
Infusion Pump Working Group
An Infusion Pump Working Group (WG) has been established to develop a Center action plan to evaluate postmarket experience with infusion pumps to determine how to improve the premarket review process. Additional objectives are to establish better communication across the Center regarding infusion pump issues and to increase interoffice responsiveness to infusion pump recalls by incorporating more involvement from the technical experts within the Center at an early stage.
CDRH Artificial Pancreas Working Group
The CDRH Artificial Pancreas Working Group was established to create innovative review processes that will accelerate the accessibility of an artificial pancreas (i.e., a closed-loop glycemic control device). This effort is aligned with FDA’s decision to add the Artificial Pancreas Project as one of its Critical Path Initiatives. The group,consisting of representatives from ODE, OIVD, OSB, and OSEL, sets CDRH review policy for these devices. They also coordinate their efforts with the Interagency Artificial Pancreas Working Group which is working on more global issues. Through collaboration with stakeholders and while applying sound scientific principles, this working group strives to develop strategies that will advance the development of new technologies in this area.
Dental Branch Represents FDA as Liaison to the American Dental Association Council on Scientific Affairs
The Dental Branch represents FDA as a liaison to the Council on Scientific Affairs of the American Dental Association (ADA). The Council, which includes both American and Canadian association representatives and liaisons from the National Institutes for Health, the Centers for Disease Control and Prevention, the American Association of Dental Research, and other associations, meets at the headquarters of the American Dental Association. The Council is composed of leading dental academicians, researchers, and association leaders from across the U.S. As a liaison, the Dental Branch presents updates on FDA dental activities, such as new guidance documents, and addresses questions from the Council on FDA scientific issues, regulations, the approval process, clinical trial design, policies regarding products regulated by FDA, and issues of interest to the Scientific Council.
Coronary Drug-Eluting Stent Safety Evaluation Initiative
The Division of Cardiovascular Devices, in conjunction with the Office of Surveillance and Biometrics, developed a program to keep the public apprised of adverse event risks resulting from the implantation of coronary drug-eluting stents (DES). DES are implanted to improve heart blood flow through diseased coronary arteries. This initiative was prompted by reports of a small but significant increase in the risk of late stent thrombosis (stent clotting) compared to bare metal stents, recognized 1 year after DES placement. In response to this signal, in September 2006, FDA published a statement on the FDA web site informing the public of this information. The statement also announced that a meeting of the FDA Circulatory System Devices Advisory Panel would be held to assess the risk of stent thrombosis and determine if additional actions are warranted. This advisory panel meeting was held on December 7 – 8, 2006, and it served as a public forum for the presentation and discussion of clinical data relevant to the DES thrombosis issue for patients treated both according to the approved DES indications and those treated “off-label,” or outside the approved indications. The advisory panel concluded that, when used according to their approved indications, both FDA-approved DES are associated with a small increase in late stent thrombosis events, but that these risks do not outweigh the benefits of DES as compared to bare metal (uncoated) stents. The panel also concluded that off-label use increased the risk of adverse events, and that additional clinical data are needed to fully evaluate these risks. The panel also recommended larger clinical studies to evaluate DES thrombosis risks in all patients. Finally, the panel recommended that labeling for DES be updated to reflect current ACC/AHA/SCAI guidelines which recommend extension of the duration of dual anti-platelet therapy (aspirin plus clopidogrel) to 12 months in DES-treated patients who are at low risk for bleeding complications. This information was further communicated to the public in a January 2007 statement on the FDA web site. DCD and OSB continue to work together to monitor DES safety and inform the public of any new and important information as needed.
FDA/NSF/NIH Computer Methods in Cardiovascular Device Design & Evaluation Workshop
The recent FDA report “Challenge and Opportunity on the Critical Path to New Medical Products” describes a looming crisis in the development of medical therapies. To facilitate more effective medical device development, improved engineering analysis methods are needed to predict whether a proposed design will function properly and safely based on the intended function of the device and the anatomic and physiologic data gathered. FDA/CDRH/ODE/DCD along with NSF and NIH are conducting a Workshop on Computer Methods in Cardiovascular Device Design & Evaluation. The purpose of this workshop is to lay important groundwork for the development of optimal computer modeling methods in medical device development. Experts from industry, academia and government will discuss issues in three key areas. First, to document the best-practices and unmet needs in industry and academia related to modeling the cardiovascular system and predicting safety and efficacy of cardiovascular devices. Second, review best practices in other industries in simulation-based engineering sciences including verification and validation. Third, establish a strategy to promote the development, application and validation of computational methods for cardiovascular device design and evaluation identifying the roles of device companies, engineering software companies, academic institutions and government agencies.
Lead Surveillance Process Workshop
Premarket submissions for new pacemaker and ICD leads are almost always leveraged by documentation of good field performance of previous generation leads. Based on recent events with ICD leads, there is concern that the current surveillance processes used to identify problems in the field, and to establish rates for those problems, are not providing timely and complete information. FDA is undertaking an initiative to work with industry and clinicians to study key steps in the surveillance process including clinical evaluation of problems, adverse event reporting, returned product analysis, and post-approval clinical studies. The first step will be for FDA to collect current practice information for these processes from Industry and the clinical community. Next, a workshop with FDA, Industry and Clinicians will be held in September 2008 to review the current practice information, and to discuss and identify the best practices. The workshop proceeding will be published to document the effort. Participation in this initiative will consist of responding to a questionnaire on current practices and then participating in the workshop. We hope the outcome of this effort will be to promote a more uniform and complete surveillance process leading to earlier and more complete identification of problems in the field, better reporting of information to industry and FDA, and better ability for FDA to make sound pre-market decisions based upon post-market data.
The Division of General Restorative and Neurological Devices (DGRND) reviews a wide variety of medical devices, including orthopedic implants, general and plastic surgery devices, physical medical and rehabilitation devices, and therapeutic and diagnostic neurological devices. In FY 2006, the division underwent a reorganization from 4 to 5 branches realigning product areas to take advantage of shared review responsibilities across reviewers with similar training and education. During the transition of review responsibilities due to the reorganization, DGRND recruited, hired and trained 2 new deputy directors, 3 new branch chiefs, 1 new project manager, and approximately 10 new clinical and scientific reviewers. Our staff rose to these challenges while maintaining the high quality of our regulatory and scientific reviews in meeting the MDUFMA review time goals. In FY 2007, the division undertook a reflective look at its internal and external interactions, its processes and procedures, and its workloads and staffing.
- Leveraging with outside groups
In FY 2006, DGRND began new outreach initiative to industry, academic, clinical and other external groups (beyond our previously established outreach efforts) such as the American Association of Neurological Surgeons, the American Society for Laser Medicine and Surgery, the Society for Interventional Radiology the Orthopaedic Device Forum, the American Academy of Orthopaedic Surgeons, the Orthopaedic Surgical Manufacturer’s Association, and the Orthopaedic Research Society. These outreach activities are intended to foster an environment of open communication among representatives of the scientific and clinical community for each of the device types under the review authorities of DGRND. It is our hope that these outreach activities will provide valuable input to DGRND on topics including clinical trial development and conduction, suggestions and development of guidance and voluntary standards for DGRND’s consideration, and suggestions for priorities for reclassification, guidance and standards for devices across DGRND. In FY 2007 the division built on its outreach program successes to include interactions with ASPS (American Society of Plastic Surgeons) and presentations to groups such as Controversies and Conversation in Cutaneous Laser and Cosmetic Surgery Meeting, the Cleveland Clinic Grand Rounds,
The International Congress on Computer Assisted Radiology & Surgery, and the American Heart Association International Stroke Conference.
- Expanding our scientific knowledge base
DGRND staff continually seeks opportunities to expand our scientific and clinical knowledge, which greatly enhances our review of innovative technologies. One example is the AAOS/FDA Orthopaedics Seminar Series, founded in 2003. The objective of the group is to organize, facilitate, and share education and training opportunities and experiences related to orthopaedic device products as a means of enhancing and accelerating product review. This year’s topic was Orthobiologics – Bone Graft and Beyond. Each seminar involves staff from across the agency, senior level academic researchers and clinicians in the biomedical sciences to discuss emerging scientific and medical theory and clinical practice in an informal setting. Outcomes of the AAOS/FDA Orthopaedic Seminar Series have led to intra- and inter-Center communication and an organized review approach of medical products targeting orthopaedic disorders and conditions. Another example of expansion of our scientific and clinical knowledge is the FDA Neural Interest Group Seminar Series, which through FY 2007 addressed cross-cutting issues that involve CDER and CBER as well as CDRH. Speakers have addressed issues related to various neurological diseases including epilepsy, depression, paralysis and brain tumors. These topics led to discussion of clinical trial designs to address patient needs.
- Reclassification Efforts
DGRND staff continues to challenge themselves to identify and assess device areas that may be appropriate for consideration of reclassification efforts. The latest in this effort was the final rule for Intervertebral body fusion devices (http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-11240.pdf), and NOA for Special Controls Guidance for Intervertebral body fusion devices. We remain committed to developing guidance documents and reclassifications in all areas of the division to allow for efficient, timely, and least burdensome review of all submissions.
- Public Health Protection/Total Product Life Cycle Efforts
DGRND participated in the PMI action team to address safety concerns regarding the use of metallic tracheal stents for the treatment of benign tracheobronchial strictures; and, off-label use of the device which could cause harm when used in the cardiovascular system. Consequently, the team requested that the indication for benign strictures be removed from the labeling if there was no data to support it. The team also prepared and proposed warning information for the devices labeling to alert the medical community. DGRND is involved in the collaborative reviewer program for CDRH with 8 staff participating in the OSB/ODE efforts and 2 staff participating in the OC/ODE efforts. The collaborative reviewer program enhances CDRH’s ability to regulate devices both pre-market and post-market. In July 2007, the Center released an AFP entitled Advice for Patients: Possible Burns or Fires from Heating Pads manufactured by HoMedics, Inc. This was the result of a recommendation by PMI Action Team (which included members of DGRND) to address issues related to a recall of the powered heating pads from that company.
- Outreach to the Public and the Clinical Community
DOED believes that the exchange of knowledge and an improved understanding of the regulatory process by consumers, manufacturers, and health care professionals are critical aspects of our public mission. To that end, DOED staff spent a significant amount of time and resources in FY 06 and 07 reaching out to our stakeholders through a variety of ways including scientific and regulatory publications in peer reviewed journals; writing educational columns in professional and consumer publications; teaching regulatory training courses, conducting seminars and making presentations at professional meetings. For the benefit of industry and clinical investigators, DOED staff completed four new device specific guidance documents and was actively involved in the development of 26 standards (ANSI, ISO, ASTM and AAMI).
Our staff provided significant technical input into the maintenance and update of the following ophthalmic and ENT device specific websites for the general public: www.fda.gov/cdrh/LASIK/faq.htm and www.fda.gov/cdrh/cochlear/. In the Contact Lens arena, DOED staff was instrumental in developing the content of a contact lens website (http://www.fda.gov/cdrh/contactlenses/index.html).
Establishment of a Fellowship in Ophthalmic Clinical Trials
DOED partnered with the National Eye Institute (NEI) in establishment of the first fellowship in Ophthalmic Clinical Trials. Fellows will commit themselves full time for 2 years. They will spend equal time at the FDA and NEI, allowing for a unique opportunity to combine knowledge in hands-on clinical trials at the NEI while obtaining regulatory knowledge at the FDA.
By raising awareness of the requirements of regulatory review of safety and efficacy and incorporating them into the schema of development and testing from the early stages, the NEI and the FDA will be better equipped to achieve a common goal: bringing safe and effective ophthalmic devices from the bench to the bedside as quickly as possible.
- Building scientific knowledge through collaborative research
DOED scientists participate in numerous collaborative studies with stakeholders within and outside of the federal government, to improve the premarket review process and to monitor the post approval performance of ophthalmic and ENT devices. Examples of ongoing premarket and postmarket collaborative efforts are described below.
Contact Lens Safety
DOED scientists collaborated with the Chemistry Branch of FDA’s Southeast Regional Laboratory in Atlanta and the Division of Healthcare Quality Promotions at the Centers for Disease Control to design and execute a pilot study entitled “Absorption of Alexidine by Contact Lenses and Lens Cases and Its Effect on Disinfection Activity against Fusarium solani." This study provided FDA with its own data on the complex interactions between contact lenses, storage cases and the multipurpose contact lens care solution removed from the market in May 2006. To conduct the study between September and November 2006, a Materials Transfer Agreement (MTA) was established with three contact lens manufacturers to supply materials. A poster was submitted to the May 2007 American Society of Microbiology General Meeting.
DOED continued discussions with the Contact Lens Institute (CLI), a manufacturer trade group, to establish a Cooperative Research and Development Agreement (CRADA) in an effort to re-evaluate the current standard test methods for contact lens disinfecting products. As part of the standards development process, DOED along with OSEL scientists worked with CLI to finalize a preliminary laboratory test of a new method to test contact lens care products. The method exposes a test solution to microbes in a contact lens case that contains lenses to model a real world environment.
MRI Compatibility of ENT devices
ENT staff has been working closely with several sponsors and the CDRH MRI Working Group to define the appropriate bench studies and/or clinical studies necessary to support MRI compatibility indications for cochlear implant devices. This work has, in particular, focused on the assessment of electrode heating and unintended stimuli during MRI procedures, and how proper procedures for specific implant designs/manufacturers during MRIs could be conveyed to MRI centers.
Critical Path Project: Driving Simulation Study
Senior review scientists in DOED continued the collaborative study with researchers at the University of Iowa where the National Advanced Driving Simulator (NADS) is located and owned by The National Highway Traffic Safety Administration. The objective of the outreach project is to determine correlations between clinical tests of visual/optical quality and visual performance in night driving conditions with the goal of finding a surrogate for functional performance.
This study has been completed and initial data analysis conducted. These results were presented at the 2007 meeting of the Association for Research in Vision and Ophthalmology. Extensive data analysis is ongoing.
As part of this critical path initiative, the DOED investigators reviewed efforts to identify reliable, cost-effective clinical tests to serve as surrogate measures of functional visual performance when evaluating how medical products affect vision. This review was published as an article, “Assessment of Visual Performance in the Evaluation of New Medical Products,” in Drug Discovery Today : Technologies (Vol. 4, Issue 2, pp. 55-61, Winter 2007). This article was included in a special Critical Path section edited by Dr. Janet Woodcock, then Deputy Commissioner and Chief Medical Officer of the FDA, and currently Director, Center for Drug Evaluation and Research.
This critical path initiative will expand ODE’s regulatory science base and assist ODE in developing a least burdensome approach in the approval of ophthalmic devices through the use of better evaluation tools.
International Club for Biomaterials and Regenerative Medicine in Ophthalmology
DOED review scientists continue to participate and have an active leadership role in The International Club for Biomaterials and Regenerative Medicine in Ophthalmology (ICBRO). ICBRO was originally founded in Europe to promote interdisciplinary cooperative work by bringing together on an international level ophthalmic scientists, engineers and clinicians to advance the quality of existing devices by improving or creating new materials and test methods to assess those materials, and to develop new biocompatible, biodegradable materials useful for regenerative medicine in ophthalmology. At the March 17, 2006 meeting, the Club provided a forum to explore novel advances such as a photochromic intraocular lens (IOLs) which will respond to the level of UV light exposure; surface modified IOLs to deliver drugs; elastomeric hydrophobic acrylic polymers for ophthalmic applications; injectable lens materials capable of providing accommodation, etc. These examples are merely a sampling of the unique and innovative developments discussed at the ICBRO meeting. The April 27, 2007 meeting will introduce even more biomaterial innovations and explore ongoing biomaterial issues.
The Division of Reproductive, Abdominal, and Radiological Devices reviews a wide variety of medical devices such as biliary stents, condoms, fetal monitors, hemodialysis equipment, radiation treatment planning systems, incontinence devices, tampons, obesity treatment devices, and diagnostic imaging systems. The division staff focused on meeting 4 major challenges for FY 06 and FY 07: meeting MDUFMA goals; communicating within and outside of the division; postmarket activities; and meetings with sponsors.
We introduced a new meeting procedure, specifically, the receipt of a background package from the sponsor prior to scheduling a meeting. We believe that the procedure has improved the timeliness, efficiency, and productivity of our meetings. The division has been diligent in its internal, pre-meeting preparations. During the pre-meeting, the FDA attendees draft responses to the questions posed by the sponsor in the background package, as well as compile additional comments to be communicated to the sponsor during the meeting. We believe preparation on the part of the division as well as the sponsor is the key to successful meetings.
Condom Labeling Review Initiative
The Obstetrics and Gynecology Devices Branch (OGDB) continued to work on the evaluation of condom labeling for "medical accuracy." Following up public comments on the 2005 Notice of Proposed Rule Making and draft guidance document, a Center-wide review team designed and received approval to conduct a two-phase label comprehension study, whose purpose is to evaluate/address issues around understandability of current and proposed condom consumer labeling. This was undertaken to address concerns expressed in public comments that the proposed language was confusing and misleading. Phase I of the study was completed in December 2007. In parallel, work continued on addressing the rest of the comments and any new published studies for the Preamble to the final rule.
Biliary Stents
The Gastroenterology and Renal Devices Branch (GRDB) is responsible for the review of marketing applications for biliary stents. Over the past several years, FDA has become increasingly concerned about the off-label promotion and use of expandable metal biliary stents within the peripheral vascular system. When labeled for the palliation of malignant neoplasms, biliary stents are reviewed as Class II (510(k)) devices in submissions containing primarily in-vitro bench testing. In contrast, vascular stents are reviewed as PMA submissions, with additional pre-clinical testing and clinical studies. Because of FDA's concerns regarding off-label use, since 1999 manufacturers marketing expandable biliary stents have been required to prominently display the biliary indication in all labeling and to include a warning stating that the device's safety and effectiveness in the vascular system have not been established. Over the past 5 years, FDA has noticed an increase in the number of Medical Device Reports (MDRs) being submitted for biliary stents used off-label. The reports have included malfunctions and serious injuries, including deaths resulting from vessel structural damage and cardiac arrhythmias and infarctions.
Based on FDA's concerns, a Center-wide Postmarket Issue (PMI) Action Team was convened. The action items from this PMI Action Team were numerous, including the convening of an industry-wide meeting with the Center Director to address off-label promotion of biliary stents; a review of all promotional material from biliary stent manufacturers, with continued surveillance and periodic review; increased scrutiny of 510(k)s for biliary stents, especially regarding performance testing and stent/delivery system dimensions and styles; increased requirements for clinical testing of new devices that are "outside the box" of biliary stent sizes and styles already cleared; and further clarification of the SE with Limitations warning and labeling restrictions for biliary stents. It is hoped that continued efforts on the part of FDA, including encouraging manufacturers and physicians to support and conduct appropriate clinical trials to assess the safety and effectiveness of expandable metal stents in peripheral vasculature locations, will result in a decrease in the use of biliary stents off-label and fewer adverse event reports.
Standards Development for Urology and Lithotripsy Devices
A Urology and Lithotripsy Devices Branch (ULDB) employee attended an IS0 standards meeting regarding endoscopes in Xiamen, China. Discussions covered the cross reference of Global Medical Device Nomenclature (GMDN) with terms and definitions for endotherapy devices; reconfirmation of IS0 8600-2 and IS0 8600-4; development of a standard for capsule endoscopy; revision of IEC 60601 Part 2-18: Particular requirements for basic safety and performance of endoscopic equipment; and the impact of the CEN/BT TF 123 standard for Luer connectors on endoscopes.
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Updated June 19, 2008
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