About FDA
Center for Devices and Radiological Health (CDRH)
2009 Preceptors
- Victoria M. Hitchins, Ph.D.
- Joseph C. Hutter, Ph.D.
- Aric D. Kaiser, M.S.
- Thomas C. Knott
- Frank W. Samuelson, Ph.D.
- Seth J. Seidman, M.S.
- Sally A Hojvat, Ph.D.
Joint Imaging and Surgical Studies Project
Research Interests:
Image-guided interventions represent a major component of therapeutic technologies available to the clinical community with new developments having greater clinical promise for the treatment and prevention of vascular disease and cancer. These two disease categories account for the majority of deaths within the US, while related devices account for the majority of regulatory submissions to CDRH. The Laboratory of Cardiovascular and Interventional Therapeutics (LCIT) investigates a range of these interventional therapeutics, including minimally invasive devices and related adjunctive agents. The research includes the development and application of new imaging and analytical technologies to our pre-clinical investigations. The imaging tools are used to guide the delivery of diagnostic or therapeutic devices to the target location, monitor devices during implantation, monitor the delivery of therapeutic interventions, such as local or targeted drug delivery, embolization or thermal ablation and sample tissues in vivo for analysis. The analytical tools are used to assess drug kinetics and the responses to interventions and for computational analysis of imaging data, including the dynamics of arterial motion. These combined imaging and analytical technologies are used to evaluate the safety and effectiveness of emerging therapeutic devices and agents and develop recommendations for pre-clinical study design.
Proposed Research Project for FDA Fellows:
FDA fellows participating in this research program will (i) propose near term recommendations for animal models and histopathological tests relevant to preclinical DES evaluation and (ii) develop longer term human-trials outcomes correlations models to identify the relative information content of specific preclinical animal models performance characteristics in human subjects. Consistent with the goal of improving the human-preclinical correlation, a Retrospective Evaluation of Preclinical Studies of Drug Eluting Manufactured Stents (REPS-DEMS) will be initiated in order to identify predictive models and develop templates for electronic data submission and analysis. The overall study goal is to pool existing preclinical animal Bare Metal Stent (BMS) and Drug Eluting Stent (DES) data that have been submitted to FDA for marketing applications and to compare preclinical measures of safety and performance to clinical data. Preclinical BMS and DES studies (1986-present) are being catalogued. These submissions are being reviewed and preclinical trial characteristics and data for each animal study identified, extracted and saved to a database for interrogation. The results from these studies will help to develop improved animal modeling recommendations and protocol templates for pre-clinical trials. These studies will identify potential failure modes, preclinical signals and deficiencies (i.e., safety and effectiveness issues), as well as determine the potential impact of animal models of disease on the evaluation of novel interventions. This research should elucidate modes of action for significant risk and combination products and provide insight for related regulatory issues. The development of more predictive models and approaches to preclinical trials will lead to the development of better products that reach the market more efficiently and with lower probability of post-market issues. The participant will acquire expertise at the preclinical bedside, bench and with analysis tools utilized for the REPS-DEMS data mining exercise. The research produced in this project will generate peer-reviewed publications that will also serve as the basis for guidance that will form the regulatory framework for these combination products. The expertise requested is an M.D., D.V.M., or Ph.D. level pathologist or experienced Master’s level pathologist/technician. Specific training as a cardiovascular pathologist is not required.
Research Interests:
There are three major areas of research that I am involved in: 1) biological responses of device materials (e.g. nanoparticles) using an in vitro system (e.g. murine macrophage cells), 2) tissue engineering (chondrocytes), and 3) infection control (e.g. cleaning, disinfection/sterilization of medical devices, endotoxin contamination on devices, infections associated with devices).
Proposed Research Project for FDA Fellow:
FDA fellows participating in the third research area should have working experience in basic microbiological techniques to allow them to understand biofilm formation on devices and to develop methods/tests to determine the effectiveness of anti-biofilm claims made by manufacturers in their submissions for their devices that are implanted or indwelling. An understanding of device materials will be helpful as well as experience in using a variety of microscopic techniques such as confocal, fluorescent, scanning and electron microscopy.
Selected Recent Publications:
- Lappalainen, S.K., S. Gomatam, and V.M. Hitchins. 2008. Residual total protein and total organic carbon levels on reprocessed gastrointestinal (GI) biopsy forceps. J. Biomed. Mater. Res: Part B: Applied (In press).
- Lyle, D.B., J. Shallcross, C. Durfor, V. Hitchins, and J. Langone. 2008. Screening biomaterials for stimulation of nitric oxide-mediated inflammation. J. Biomed. Mater. Res. (In press).
- Choi, J., Q. Zhang, V. Hitchins, N.S. Wang, and V. Reipa. 2007. Cytotoxicity of silicon nanocrystals. Proc. SPIE Vol. 6645, 66455-Q1-8.
- Blustein, J., V.M. Hitchins and E. Woo. 2004. Letter to the Editor regarding endotoxin on ophthalmic sponges used in LASIK. J. Cat. Refract. Surg. 30:2027-2028.
- Bryans, T.D., C. Braithwaite, J. Broad, F. Cooper, K.R. Darnell, V.M. Hitchins, A.J. Karren, and P.S. Lee. 2004. Bacterial endotoxin testing: a report on the methods, background, data, and regulatory history of extraction recovery efficiency. Biomed. Instrument. Tech. 37: 73-78.
- Lucas, A.D., K. Merritt, and V.M. Hitchins. 2004. Damage of office supply, personal use items, and over-the-counter medical devices after sterilization by ethylene oxide gas, electron beam, and gamma radiation. Biomed. Instrument. Tech. 38: 476-484.
- Brown, S.A., K. Merritt, S.G. McNamee, and V.M. Hitchins. 2002. Effects of different cleaning, disinfection and sterilization methods on tensile strength of materials used for single use devices (SUDs). Biomed. Instrument. Tech. 36: 23-27.
- Brown, S.A., K. Meritt, T.O. Woods and V.M. Hitchins. 2002. The effects of use and simulated reuse on percutaneous transluminal coronary angioplasty balloons and catheters. Biomed. Instrument. Tech. 35:312-322.
- Whitby, J.L. and V.M. Hitchins. 2002. Endotoxin levels in the steam and in the reservoir of table-top sterilizers. J. Refract. Surg. 18: 51-57.
- Hitchins, V.M. and K. Merritt. 1999. Decontaminating particles exposed to bacterial endotoxin (LPS). J. Biomed. Mater. Res. 46: 434-437.
Research Interests:
Since 1998, various silicone hydrogel contact lenses have been introduced into the US market. At the same time, multi-purpose solutions (MPS or solutions that can be used for cleaning, disinfecting and storing the lenses) have become more complex with additives to facilitate moisture retention, comfort, lubrication, and biocompatibility. This increase in complexity has had the unintended consequence of being linked to two serious infectious outbreaks of fusarium solani and acanthamoeba, which resulted in serious injuries to contact lens users. The outbreaks were believed to be caused by the formation of biofilms and/or preservative depletion (fusarium) and/or possibly conversion of micro-organisms to a resistant cyst form (acanthamoeba). The products linked to the outbreaks performed well in the pre-market testing recommended by the FDA guidance of 1997, which indicated to us that our pre-market testing require updating. The proposed research project will evaluate various lenses and solution products to identify the factors that could contribute to infectious outbreaks with the goal of improving existing premarket testing strategies.
Proposed Research Project for FDA Fellow:
FDA fellows assigned to this project will develop new strategies to test lenses and solutions to predict products' disinfection performance in real world conditions. A first step would be to categorize the numerous silicone hydrogels into fundamental groups based on how these materials interact with various types of MPS components (preservatives, surfactants, additives). This task would involve development of more robust analytical procedures to characterize the various solution components in mixtures, as well as screening a cross section of lens products and there tendency to disrupt the chemistry of care product solution by lens absorption of components. Also, the relative tendency of various lens materials to cause adherence of bacterial in conjunction with various types of care products additives (moisture retention, comfort, lubrication) would be measured. The fellow would be expected to contribute to the development of international standards on test methods for contact lens solutions as well as updating the guidance for premarket testing for lenses and solutions.
Selected Recent Publications:
- Hutter, J.C., "FDA Group V: Is a Single Grouping Sufficient to Describe SiH Performance?" Editorial, www.siliconehydrogels.org/editorials, Nov. 2007
- Warburton, K.F., J. A. Noble-Wang, B. M. Henry, S. L. Holliday, M. K. Smith, J. C. Hutter, and J. F. Saviola, “Absorption of Alexidine by Contact Lenses and lens Cases and Its Effect on Disinfection Activity against Fusarium solani, “ Poster, American Society for Microbiology, 107th General Meeting, Toronto Canada, May 21-25, 2007.
- McDermott, M.K., I.S. Isayeva, T.M. Thomas, A.S. Lee, A.D. Lucas, C.N. Witkowski, and J.C. Hutter, "Characterization of the Structure and Properties of Authentic and Counterfeit Polypropylene Surgical Meshes," Hernia 10(2):131-142, Apr 2006
- Hutter, J.C., H.M.D. Luu, and L.W. Schroeder, "A Biological Model of Tamponade Gases Following Pneumatic Retinopexy", Curr. Eye Res., 25(4):197-206 2002
- Hutter, J.C., M.C. Long, H.M.D. Luu, and L.W. Schroeder, "Prediction of the Shelf Life of Cellulose Acetate Hemodialyzers by Monte Carlo Simulation," ASAIO J. 47:522-527, 2001
- H.M.D. Luu, and J.C. Hutter, "Bioavailability of Octamethylcyclotetrasiloxane (D4) after Exposure to Silicones by Inhalation and Implantation," Env Health Pers 109(11):1095-1101, 2001.
- Lucas A.D., J.A. Kalson, J.C. Hutter, and R.R. Wallis, "Identifying Toxic Degradation Products in Cellulose Acetate," J Biomed Mater Res (Appl Biomater) 53:449-456, 2000
- H.M.D. Luu, and J.C. Hutter, "Pharmacokinetic Modeling of 4,4’-Methylenedianiline Released from Polyurethane Dialyzer Potting Materials," J Biomed Mater Res (Appl Biomater) 53:276-286, 2000.
- Hutter, J.C., M.J. Kuehnert, R.R. Wallis, A.D. Lucas, S. Sen, and W.R. Jarvis: "Acute Onset of Diminished Vision and Hearing Traced to Hemodialysis Treatment with Aged Dialyzers". JAMA 283: 2128-2134, April 23, 2000
- Hutter, J.C., H.-M.D. Luu, P.M. Mehlaff, A.L. Killam, and H.C. Dittrich: "A Physiologically Based Pharmacokinetic Model for Fluorocarbon Elimination Following the Administration of a Perfluoropropane-Albumin Sonographic Contrast Agent". J. Ultrasound in Med., 18:1-11, Jan. 1999.
Research Interests:
Aric Kaiser, a biomedical engineer with experience in tissue mechanics and mechanical testing, has regulatory and scientific interests in the design and evaluation of products intended to treat orthopedic disorders. Of particular interest are tissue-engineered medical products (combination products) and devices intended to serve as functional replacements for the diseased or damaged tissue, e.g., products intended to repair/regrow damaged cartilage with functional tissue rather than implantation of synthetic materials as in total joint replacements. Recent work has focused on bone void fillers containing calcium salts, collagen and/or recombinant human proteins or synthetic peptides.
The Division of General, Restorative and Neurological Devices has had a dramatic increase in the number of applications for bone void fillers used in a variety of orthopedic applications in the last several years. The complexity of these fillers, particularly those incorporating recombinant human proteins or synthetic peptides, and their possible risk of immunological and other reactions, would be enhanced by a review and production of a “lessons learned” and/or minimum non-clinical evaluation document based on recent applications. In addition to these types of general documents, a guidance document describing the requirements for submissions investigating fracture healing would also be very useful to agency staff and industry. The fellow would also participate in reviews of pre-IDEs, IDEs, 510(k)s and PMAs on these products and interact with staff from DAGID for products with dental and orthopedic uses, from OSB concerning post-market issues and staff from CDER concerning pre- and post-market issues associated with these products.
Proposed Research Project for FDA Fellows:
FDA fellows participating in this program will learn the basic science, regulatory science and review processes associated with the regulation of bone void fillers (with and without recombinant human proteins or synthetic peptides.) The project will include an evaluation of past applications and clearances/approvals to look for commonly resolved issues, tests and clinical study design in order to provide background for new guidance documents or other internal/external communications within FDA and with industry.
Selected Recent Publications:
- Nayak, S and Kaiser, AD: Dose-dependent effects of gamma irradiation sterilization on the material properties of large fresh-frozen human cortical bone allografts, 37th Ann ORS, 1991.
- Kaiser, AD, McFarland, RD, Dawisha, SM and Leibenhaut, S: Points to Consider in the Design of Nonclinical and Clinical Evaluations of Products Intended to Repair or Replace Articular Cartilage, FDA Science Forum, April 27-28, 2005.
- Kaiser, AD: Examination of strain pattern location-dependence in young human patellar tendon-bone subunits using optical techniques, Master's thesis, University of Cincinnati, 1987.
- Sugiyama, H, Whiteside, LA and Kaiser AD: Examination of rotational fixation of the femoral component in total hip arthroplasty: A mechanical study of micromovement and acoustic emission, John Charnley Award for Research of Total Hip Arthroplasty, Proceedings of the Hip Society, CORR, 249:122, 1989.
- Kaiser, AD: Science-based Testing for Combination Devices, Proceedings from the Workshop on Science-Based Assessment – Accelerating Product development of Combination Medical Devices, Bonnie A. Scarborough, ed., The National Academies Press, 2004.
- Preparation of IDEs and INDs for Products Intended to Repair or Replace Articular Cartilage – Guidance Document – draft
- "Overview of the History of FDA Regulation of Devices Made from Bone", FDA Open Public Meeting on: Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair, August 2, 2000.
- "Medical Device Regulations—From Research to Marketing: Regulation of Bone Graft Substitutes." Biomedical Engineering Society Annual Meeting, September 28, 2005.
- "From Your Lab to the Market. Pathways to the Market: Regulatory Requirements." Orthopedic Research Society Annual Meeting, February 13, 2007.
- "Combination Products That Include Biologics - Novel Combinations Require Novel Assessments", WCBP 2008, 12th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, January 30, 2008.
Research Interests:
Image-guided interventions represent a major component of therapeutic technologies available to the clinical community with new developments having greater clinical promise for the treatment and prevention of vascular disease and cancer. These two disease categories account for the majority of deaths within the US, while related devices account for the majority of regulatory submissions to CDRH. The Laboratory of Cardiovascular and Interventional Therapeutics (LCIT) investigates a range of these interventional therapeutics, including minimally invasive devices and related adjunctive agents. The research includes the development and application of new imaging and analytical technologies to our pre-clinical investigations. The imaging tools are used to guide the delivery of diagnostic or therapeutic devices to the target location, monitor devices during implantation, monitor the delivery of therapeutic interventions, such as local or targeted drug delivery, embolization or thermal ablation and sample tissues in vivo for analysis. The analytical tools are used to assess drug kinetics and the responses to interventions and for computational analysis of imaging data, including the dynamics of arterial motion. These combined imaging and analytical technologies are used to evaluate the safety and effectiveness of emerging therapeutic devices and agents and develop recommendations for pre-clinical study design.
Proposed Research Project for FDA Fellows:
FDA fellows participating in this research program will (i) propose near term recommendations for animal models and histopathological tests relevant to preclinical DES evaluation and (ii) develop longer term human-trials outcomes correlations models to identify the relative information content of specific preclinical animal models performance characteristics in human subjects. Consistent with the goal of improving the human-preclinical correlation, a Retrospective Evaluation of Preclinical Studies of Drug Eluting Manufactured Stents (REPS-DEMS) will be initiated in order to identify predictive models and develop templates for electronic data submission and analysis. The overall study goal is to pool existing preclinical animal Bare Metal Stent (BMS) and Drug Eluting Stent (DES) data that have been submitted to FDA for marketing applications and to compare preclinical measures of safety and performance to clinical data. Preclinical BMS and DES studies (1986-present) are being catalogued. These submissions are being reviewed and preclinical trial characteristics and data for each animal study identified, extracted and saved to a database for interrogation. The results from these studies will help to develop improved animal modeling recommendations and protocol templates for pre-clinical trials. These studies will identify potential failure modes, preclinical signals and deficiencies (i.e., safety and effectiveness issues), as well as determine the potential impact of animal models of disease on the evaluation of novel interventions. This research should elucidate modes of action for significant risk and combination products and provide insight for related regulatory issues. The development of more predictive models and approaches to preclinical trials will lead to the development of better products that reach the market more efficiently and with lower probability of post-market issues. The participant will acquire expertise at the preclinical bedside, bench and with analysis tools utilized for the REPS-DEMS data mining exercise. The research produced in this project will generate peer-reviewed publications that will also serve as the basis for guidance that will form the regulatory framework for these combination products. The expertise requested is an M.D., D.V.M., or Ph.D. level pathologist or experienced Master’s level pathologist/technician. Specific training as a cardiovascular pathologist is not required.
Research Interests:
The Office of Compliance brings together scientific and investigational evidence with the law to determine the regulatory status of devices. On a broader scale, the Center for Devices and Radiological Health (CDRH) has recently launched the Matrix or Network. This draws together scientists, medical doctors, and regulatory experts from all CDRH offices to concentrate on specific public health issues.
One of our concerns involves surgical meshes. Meshes are indicated for supporting hernia repairs and internal organs and treating urinary incontinence. They are manufactured from materials like polypropylene and collagen that are similar to materials used in sutures. Depending on their use they may be multilayered, have various “wings” to attach them, and come in various weaves.
FDA has received numerous reports of adverse events related to the use of these devices. Several patients who have experienced adverse events have contacted FDA individually. These patients experience intense pain, infections, reactions to the mesh as a foreign body, erosion and perforation of organs, inflammation, etc. A Network committee is examining this issue to determine whether further action is warranted.
Proposed Research Project for FDA Fellows:
FDA fellows participating in this issue may perform one or more of several tasks. The fellow could research the materials used in the manufacture of meshes and their construction, weaving, shapes, coatings, manufacturing materials, sterilization techniques, flexibility, strength, etc., and how these factors affect the biocompatibility of the meshes. The fellow may characterize mesh samples obtained from manufacturers in conjunction with CDRH scientists and engineers. Other aspects might include analyzing epidemiological information and performing meta analyses of available data to determine the significance of the adverse events reported to FDA.
Research may consist of searching the scientific literature, reviewing premarket submissions, discussing issues with device users, analyzing adverse event reports, reviewing product labeling and instructions for use, analyzing meshes in a laboratory, etc.
The results from this research may suggest or support further actions that FDA should take to help protect and promote the public health and may be published in scientific literature or become part of internal documentation.
Research Interests:
Image-guided interventions represent a major component of therapeutic technologies available to the clinical community with new developments having greater clinical promise for the treatment and prevention of vascular disease and cancer. These two disease categories account for the majority of deaths within the US, while related devices account for the majority of regulatory submissions to CDRH. The Laboratory of Cardiovascular and Interventional Therapeutics (LCIT) investigates a range of these interventional therapeutics, including minimally invasive devices and related adjunctive agents. The research includes the development and application of new imaging and analytical technologies to our pre-clinical investigations. The imaging tools are used to guide the delivery of diagnostic or therapeutic devices to the target location, monitor devices during implantation, monitor the delivery of therapeutic interventions, such as local or targeted drug delivery, embolization or thermal ablation and sample tissues in vivo for analysis. The analytical tools are used to assess drug kinetics and the responses to interventions and for computational analysis of imaging data, including the dynamics of arterial motion. These combined imaging and analytical technologies are used to evaluate the safety and effectiveness of emerging therapeutic devices and agents and develop recommendations for pre-clinical study design.
Proposed Research Project for FDA Fellows:
FDA fellows participating in this research program will (i) propose near term recommendations for animal models and histopathological tests relevant to preclinical DES evaluation and (ii) develop longer term human-trials outcomes correlations models to identify the relative information content of specific preclinical animal models performance characteristics in human subjects. Consistent with the goal of improving the human-preclinical correlation, a Retrospective Evaluation of Preclinical Studies of Drug Eluting Manufactured Stents (REPS-DEMS) will be initiated in order to identify predictive models and develop templates for electronic data submission and analysis. The overall study goal is to pool existing preclinical animal Bare Metal Stent (BMS) and Drug Eluting Stent (DES) data that have been submitted to FDA for marketing applications and to compare preclinical measures of safety and performance to clinical data. Preclinical BMS and DES studies (1986-present) are being catalogued. These submissions are being reviewed and preclinical trial characteristics and data for each animal study identified, extracted and saved to a database for interrogation. The results from these studies will help to develop improved animal modeling recommendations and protocol templates for pre-clinical trials. These studies will identify potential failure modes, preclinical signals and deficiencies (i.e., safety and effectiveness issues), as well as determine the potential impact of animal models of disease on the evaluation of novel interventions. This research should elucidate modes of action for significant risk and combination products and provide insight for related regulatory issues. The development of more predictive models and approaches to preclinical trials will lead to the development of better products that reach the market more efficiently and with lower probability of post-market issues. The participant will acquire expertise at the preclinical bedside, bench and with analysis tools utilized for the REPS-DEMS data mining exercise. The research produced in this project will generate peer-reviewed publications that will also serve as the basis for guidance that will form the regulatory framework for these combination products. The expertise requested is an M.D., D.V.M., or Ph.D. level pathologist or experienced Master’s level pathologist/technician. Specific training as a cardiovascular pathologist is not required.
Research Interests:
The FDA evaluates computer aided diagnosis devices that are intended for clinical use for their safety and effectiveness. Frank Samuelson performs research on statistical methods for the evaluation of such CAD devices. These methods are used to evaluate CAD devices for technical effectiveness as well as clinical and user effectiveness. Some of these methods are directly used by sponsors that submit CAD devices to the FDA. Frank Samuelson utilizes and provides expertise for the OSEL computing cluster. The OSEL computing cluster provides compute power for much of the scientific modeling within the Center.
FDA Fellows participating in this research program will create and evaluate models that describe the statistical change in performance and aggression of users (primarily clinical radiologists) of CAD software. These models are necessary for understanding how CAD devices affect the ability of radiologists to diagnose patients and therefore the safety and effectiveness of these devices. Current models do not estimate or account for some kinds of effects, such as diagnostic aggression, that CAD devices have been demonstrated to have on radiologists.
Selected Recent Publications:
- Gallas, B.D., Bandos, A., Kupinski, M., Samuelson, F.W, &Wagner, R.F., "Biases with a Three-Way Bootstrap in ROC Analysis", submitted 2008, Communications in Statistics.
- Samuelson, F., Petrick, N., & Paquerault, S., "Advantages and Examples of Resampling for CAD Evaluation", Proceedings of the 2007 IEEE International Symposium on Biomedical Imaging, p. 492-495 (2007).
- Abdo, A. A., et al., “Discovery of TeV Gamma-Ray Emission from the Cygnus Region of the Galaxy”, Astrophysical Journal Letters, 658, 2007, L33-L36
- Samuelson, F. & Petrick, N., “Comparing Image Detection Algorithms Using Resampling”, Proceedings of the 2006 IEEE International Symposium on Biomedical Imaging, p. 1312-1315 (2006).
- Samuelson, F. & Wagner R., “Bootstrapped MRMC Confidence Intervals”, Medical Imaging 2005, Proceedings of the SPIE, 5749, 15-20.
- Petrick, N., Gallas, B., Samuelson, F., Wagner, R., & Myers, K., “Influence of Panel Size and Expert Skill on Truth Panel Performance when Combining Expert Ratings”, Medical Imaging 2005, Proceedings of the SPIE, 5749, 49-54.
- Atkins, R. et al., "TeV Gamma-Ray Survey of the Northern Hemisphere Sky Using the Milagro Observatory", The Astrophysical Journal 608:680-685 (2004).
Research Interests:
My research and regulatory duties are related to wireless coexistence and electromagnetic compatibility (EMC) of medical devices. Of special interest to me are intentional wireless emitters such as radio frequency identification (RFID), wireless local area networks (WLAN), and cellular phones. I also enjoy my work in the development of EMC standards for implantable pacemakers and implantable cardiac defibrillators (ICDs).
FDA Fellows participating in this research program will develop laboratory skills in characterizing and exposing radio frequency identification (RFID) signals to critical care medical devices. The research produced in this project will generate peer-reviewed publications and electromagnetic compatibility (EMC) test methods for RFID around medical devices. Fellows having a background in biomedical or electrical engineering are preferred.
Selected Recent Publications:
- Seidman S., Ruggera P., Lewis, B., Brockman R., Shein M., "Electromagnetic Compatibility of Pacemakers and Implantable Cardiac Defibrillators Exposed to Radio Frequency Identification Readers," International Journal of Radio Frequency Identification Technology and Applications, Vol. 1, No. 3, page 237, 2007.
- Bassen, H., Seidman S., Rogul J., Desta A., Wolfgang K., "An RFID Exposure system for Evaluation of Various Formulations of Drug Products," IEEE Applications and Practice Magazine. Vol 1, No. 1, 17-23, 2007.
- Wu D., Qiang R., Chen J., Seidman S., Witters D., Kainz W., "Possible over exposure of pregnant women to emissions from a walk through metal detector," Physics in Medicine and Biology, Sept. 10, 2007.
- Wu D., Qiang R., Kainz W., Seidman S., "Safety Evaluation of Walk-Through Metal Detectors," Practical Papers of EMC Newsletters, Summer 2007.
- Esser A. T., Gowrishankar T. R. , Smith K. C., Kainz W., Seidman S. J. and J. C. Weaver J. C., "The opportunity for in-silico bioelectromagentics, BEMS 2006, 28th Annual Meeting June 11-15, Cancun, Mexico, 2006
- Wu D., Qiang R., Chen Ji, Seidman S., Kainz W., "Possible non-compliance of one walk through metal detector for pregnant women models as compared to ICNIRP Guidelines", BEMS 2006, 28th Annual Meeting June 11-15, Cancun, Mexico, 2006.
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Sally A Hojvat, Ph.D.Division of Microbiology Devices
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Research Interests:
Regulation of in-vitro diagnostic devices for the detection and diagnosis of infectious diseases.
The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) regulates all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs). The Office was formed November 17, 2002, in order to consolidate all regulatory activities for IVDs. OIVD has a dual charge to foster the rapid transfer of new IVDs into the marketplace while preventing marketing of unsafe or ineffective devices. To accomplish this OIVD combines the functions of all the offices within CDRH into one organizational unit for cradle-to-grave regulation of in vitro diagnostic devices (IVDs).
The Division of Microbiology is responsible for the pre-market and post- market review of devices for the detection and diagnosis of infectious diseases. These can range from rapid hand held devices for the detection of influenza or streptococcal infection to complex multiplex devices capable of detecting multiple microorganisms involved in respiratory infections, gastrointestinal infections and systemic fungal disease.
Proposed Research Project for FDA Fellow:
The proposed project would be to develop policies /processes for reviewing multiplex devices/ panels of multiple microorganisms. Current MDUFMA 510(k) timelines were developed under the assumption that a single organism/device would be under review.
Authored FDA Guidance Documents:
Class 11 Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus-Guidance for Industry and FDA Staff. October 30,,2003
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays : Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: February 9, 2006
Informed Consent for In Vitro Device Studies Using Leftover Human Specimens that are not Individually Identifiable. April 25, 2006
Draft Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions. October 25, 2007
Assay Migration Studies for In Vitro Diagnostic Devices January 5, 2009
Numerous presentations on regulation of in-vitro diagnostic devices