Medical devices; hematology and pathology devices: reclassification of automated blood cell separator device operating by centrifugal separation principle. Final rule

The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.     

Android forensics: Interpretation of timestamps

Interpretation of traces found on Android devices is an important aspect of mobile forensics. This is especially true for timestamps encountered on the device under investigation. In the presence of both naive and UTC timestamps, some form of timestamp normalisation is required. In addition, the investigator needs to gain some understanding of potential clock skew that may exist, especially when evidence from the device under investigation has to be correlated to real world events or evidence from other devices. A case study is presented where the time zone on the Android device was set incorrectly, while the clock was set to correspond to the time zone where the device was actually located. Initially, the fact that both time zones enforced daylight saving time (DST) at different periods was expected to complicate the timestamps normalisation. However, it was found that the version of the Time Zone Database on the device was outdated and did not correspond to the actual time zone rules for the given period. After the case study, the results of experiments on a broader range of devices are presented. Among other things, these results demonstrate a method to detect clock skew based on the mmssms.db database. However, it was also found that the applicability of this method is highly dependent on specific implementation choices made by different vendors.     

Early adopters of the magical thinking cap: a study on do-it-yourself (DIY) transcranial direct current stimulation (tDCS) user community

Among currently available technologies, transcranial direct current stimulation (tDCS) is one of the most promising neuroenhancements because it is relatively effective, safe, and affordable. Recently, lay people have begun to build—or purchase—the tDCS device to use it at home for treatment or as a cognitive enhancer. The tDCS device is currently not covered by the existing regulatory framework, but there are still significant potential risks of misusing this device, and its long-term effects on the brain have not been fully explored. Thus, researchers have argued the need for regulations or official guidelines for the personal use of tDCS. However, until now, no systematic research on the do-it-yourself (DIY) tDCS user community has been done. The present study explores the basic demographic characteristics of DIY tDCS users as well as why and how they are using this device through a questionnaire survey, in-depth interviews, and a content analysis of web postings on the use of tDCS. This preliminary but valuable picture of the DIY tDCS user community will shed light on future studies and policy analysis to craft sound regulations and official guidelines for the use of tDCS.     

Some Examples of Applications of a Microthermal Desorption Device in the Forensic Laboratory

Abstract:  Several applications of a microthermal desorption device for analysis of small forensic samples are presented. The method uses a solid phase microextraction holder with the fiber removed. In addition to samples of inks on paper, this device was successfully used for analysis of toners, various stains on bank notes, and lipstick stains on paper. Other small items encountered in a forensic science laboratory were also analyzed: particles of smokeless powder, particles of coffee, and automotive clear topcoat layer. The desorbed compounds were analyzed by gas chromatography with a flame ionization detector or by gas chromatography–mass spectrometry. This device can be used in connection with any kind of gas chromatograph. By selection of different injector temperatures, fractionated thermal desorption of samples is achieved. The procedure was demonstrated on samples of ballpoint pen ink of various age.     

Salient factor score validation—A 1972 release cohort

In October 1973, the United States Board of Parole adopted an actuarial device, termed a “salient factor score”, as a risk assesment aid. This device was constructed and initially validated on a sample of 1970 releases utilizing a two year follow-up period for each case. However, as the utility of a predictive device depends upon its a ability to predict to prospective samples, periodic validation is required. This paper describes the application of the salient factor score to a subsequent validation sample of prisoners released during 1972 and discusses the effects of using various outcome measures.     

A simple dictation device.

A simple device for autopsy and scene dictation uses a small cassette recorder with a built-in microphone attached to a remote push-button switch worn on the belt or waistband. The recorder is carried in a shirt or scrub suit pocket and is functional under a protective apron or gown. The components, construction, advantages, and disadvantages of the device are presented.     

Cardiovascular and neurological devices; reclassification of two embolization devices. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify two embolization device types from class III (premarket approval) into class II (special controls). The agency is also changing the names and revising the identifications of these devices. The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain types 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. FDA is reclassifying these devices on its own initiative on the basis of new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices.     

Development of a Novel Finger-Trigger Interface for Trigger Pull Measurement

Trigger pull is the force that needs to be exerted on the trigger to discharge a firearm. The measurement of trigger pull can assist in the evaluation of the safety, function, and manufacturing characteristics associated with a firearm during the forensic firearm examination process. Nonetheless, the accuracy and uncertainty of trigger pull measurements may be affected by the measuring device, test procedure, and environmental conditions. In this work, an innovative finger-trigger interface device was developed to facilitate accurate trigger pull measurements. The idea was to reduce the variation related to the position of the measurement device on the trigger in existing measuring methods and devices. Three force sensors based on different technologies were initially evaluated. While two of the three sensors failed to produce data, the miniature capacitive plate sensor exhibited high precision and a linear response over the range of typical trigger pulls. To examine the effects of the finger-trigger interface on trigger pull measurement, different sensor housing prototypes were designed in silico and 3D printed for the construction of three finger-trigger interface devices. The performance of each finger-trigger interface device was evaluated by measuring the trigger pulls of several selected firearms and comparing the data to a previously published study. Our preliminary results demonstrated the novel finger-trigger interface device offered a new way to measure trigger pull in situ with acceptable accuracy and precision.     

Medical devices; clinical chemistry and clinical toxicology devices; instrumentation for clinical multiplex test systems. Final rule

The Food and Drug Administration (FDA) is classifying instrumentation for clinical multiplex test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

Medical devices; general hospital and personal use devices; classification of implantable radiofrequency transponder system for patient identification and health information. Final rule

The Food and Drug Administration (FDA) is classifying the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

Medical Device Regulation and Nanotechnologies: Determining the Role of Patient Safety Concerns in Policymaking

Balancing acceptable risks and early release of products for new treatments in patient care with the rights of patients and the rights of stakeholders—device makers and regulators—is a complex task. With the rapid technological innovations of the last two decades, providing a balanced voice to all participants is essential, but a sense of urgency depends on which side of the aisle one is sitting: on the side of patients, surgeons, regulators, and device makers; or that of providers and scientific advisors. A review of the medical device political economy suggests why patient safety concerns are or should be kept alive throughout the entire regulatory cycle from clinical evaluation and premarket checks to their final use in a huge variety of clinical settings around the globe. The key issue for nano‐enhanced devices now is whether the uncertainties and perceived risks can be reduced through more stringent regulatory requirements and proactive measures without stifling innovation and development of new treatments for patients.     

Medical devices; general and plastic surgery devices; classification of tissue adhesive with adjunct wound closure device intended for topical approximation of skin. Final rule

The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.' The agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.     

Medical devices; dental devices; classification of oral rinse to reduce the adhesion of dental plaque. Final rule

The Food and Drug Administration (FDA) is classifying the oral rinse to reduce the adhesion of dental plaque device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

Medical devices; ear, nose, and throat devices; classification of olfactory test device. Final rule

The Food and Drug Administration (FDA) is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Olfactory Test Device." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that is the special control for the device.     

Medical devices; illustrative and designated lists for device tracking--FDA. Final rule and request for comments

The Food and Drug Administration (FDA) is amending the medical device tracking regulations to add the temporo-mandibular joint prostheses to the illustrative list of devices and the penile inflatable implant to the list of devices designated for tracking. These devices are being added to the illustrative and designated device lists based on the significance of the risk to health posed by their use. This action requires manufacturers to track these devices after distribution so that they can be located in the event of a recall or patient notification action. FDA requests comments on these changes. Elsewhere in this issue of the Federal Register, the agency is announcing notification of the change of status of the device tracking regulations and is suspending the effective date of the regulations until August 29, 1993.     

Medical devices; general and plastic surgery devices; classification of the low level laser system for aesthetic use. Final rule

The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.     

The use of orthopedic surgical devices for forensic identification

Surgically implanted devices have become increasingly common in modern skeletal material. Therefore, having the knowledge of the variety of implanted orthopedic devices, their manufacturer, and where to find and how to use identifying numbers in such implants can assist in the identification process when traditional methods are not applicable. Orthopedic device manufacturers are required by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997 to track permanently implanted devices. Manufacturer information on orthopedic devices associates the orthopedic surgeon who implanted the device with the patient. By providing a current list of the most common orthopedic device manufacturers in the U.S.A. and the associated contact information, investigators will have updated tools for the individuation process. Despite numerous complicating factors regarding how device data are tracked, the information presented here can assist forensic professionals with obtaining presumptive and/or positive identifications.     

Medical devices; immunology and microbiology devices; classification of gene expression profiling test system for breast cancer prognosis. Final rule

The Food and Drug Administration (FDA) is classifying gene expression profiling test systems for breast cancer prognosis into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.     

Medical Devices; general and plastic surgery devices; classification of contact cooling system for aesthetic use. Final rule

The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.     

Using anisotropic diffusion for efficient extraction of sensor noise in camera identification

Each digital camera has an intrinsic fingerprint that is unique to each camera. This device fingerprint can be extracted from an image and can be compared with a reference device fingerprint to determine the device origin. The complexity of the filters proposed to accomplish this is increasing. In this note, we use a relatively simple algorithm to extract the sensor noise from images. It has the advantages of being easy to implement and parallelize, and working faster than the wavelet filter that is common for this application. In addition, we compare the performance with a simple median filter and assess whether a previously proposed fingerprint enhancement technique improves results. Experiments are performed on approximately 7500 images originating from 69 cameras, and the results are compared with this often used wavelet filter. Despite the simplicity of the proposed method, the performance exceeds the common wavelet filter and reduces the time needed for the extraction.