PDA devices

The largest two-dimensional PDA-device, which is commercially available, contains 128 X 128 elements, with overall dimensions of 8 x 8 mm. Again, it may find applications in some special cases, but not generally for X-ray detection. 

The pharmacist or physician can report any problems experienced with dmg products and medical devices. In cases where the PDA and/or manufacturer finds that a marketed product constitutes an actual or potential threat to the safety and welfare of the pubhc, that product must be withdrawn from the marketplace, ie, recalled. Several classes of recalls exist, depending on the relative danger that the product exhibits. C/ass I dmgs pose a serious health threat and may require withdrawal at the consumer level C/ass II dmgs pose a possible or potential health problem that usually means withdrawal at the pharmacy or wholesaler levels and C/ass III dmgs may present a remote hazard to health and safety. 

Post-amendment devices ate automatically classified as Class III devices. However, a post-amendment device can be brought to market under the 510(k) process, if the PDA determines that the device is "substantially equivalent" to a preamendment device. If the post-amendment device is identical to a preamendment device, it is substantially equivalent. Then the 510(k) is accepted by the PDA and the post-amendment device is placed in the same class as the preamendment device to which it is substantially equivalent. Pot example, a wound dressing identical to a preamendment Class I wound dressing would be found substantially equivalent to the preamendment wound dressing and classified in Class I. 

Unless otherwise exempt, a firm must submit a premarket notification, also called a 510(k), to the PDA 90 days before it intends to market a device for the first time (17). The 510(k) submission must contain sufficient information to show that the device in question is substantially equivalent to a legally marketed device for a particular intended use. This notification is also required for a product when there is a change or modification to a product that may significantly affect the safety or effectiveness of the device, or when there is a significant change or modification to the intended use of the device. 

Class III devices, unless they are substantially equivalent to a device already marketed without a PMA appHcation, require formal PDA approval through the PMA process before initial sale. The PMA process is comparable to the new dmg approval process (18). In both cases, safety and effectiveness data must be reviewed by PDA prior to marketing. An approved PMA appHcation acts like a private Hcense granted to the appHcant to market a particular device. Other firms seeking to market the same type of device for the same use must also have an approved PMA. 

PMA requirements differ between preamendment and post-amendment devices. Preamendment devices are those in commercial distribution before May 28, 1976 post-amendment devices are those first commercially distributed after the date. Class III post-amendment devices that are not substantially equivalent to preamendment Class III devices are considered new devices. Manufacturers of such devices are required to obtain PMA appHcation approval before marketing these. If the post-amendment device is substantially equivalent to a preamendment device and PDA has not initiated a regulatory process specifically requiring the submission of a PMA for the device category, a 510(k) submission can be made. 

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

The main detectors used in AES today are photomultiplier tubes (PMTs), photodiode arrays (PDAs), charge-coupled devices (CCDs), and vidicons, image dissectors, and charge-injection detectors (CIDs). An innovative CCD detector for AES has been described [147]. New developments are the array detector AES. With modem multichannel echelle spectral analysers it is possible to analyse any luminous event (flash, spark, laser-induced plasma, discharge) instantly. Considering the complexity of emission spectra, the importance of spectral resolution cannot be overemphasised. Table 8.25 shows some typical spectral emission lines of some common elements. Atomic plasma emission sources can act as chromatographic detectors, e.g. GC-AED (see Chapter 4). 

One should note that to realize practical devices based on these materials, in addition to the research described in the preceding, research in processing and fabrication techniques related to the PDA s is necessary. In fact, this is also true for inorganic semiconductor materials. 

Fuel cells can be used to power a variety of portable devices, from handheld electronics such as cell phones and radios to larger equipment such as portable generators. Other potential applications include laptop computers, personal digital assistants (PDAs), and handheld video cameras—almost any application that has traditionally used batteries. These fuel cells have the potential to last more than three times as long as batteries between refueling. 

Laboratories are already investigating the use of wireless devices that can be used to more efficiently access their software applications and data. Tablet PCs and personal digital assistants (PDA) are now capable of providing secure, wireless access to many of the applications that are used in the laboratory. 

The need for different and novel materials as possible DLs has increased substantially in the last few years—especially with the development of new and more complex fuel cell designs. Lurthermore, the interest in small-scale fuel cells to be used as battery replacements in portable electronic devices such as PDAs, laptops, cell phones, music players, etc. has pushed the research for irmovative, inexpensive, and efficient fuel cells further [72,73]. Therefore, it is not surprising that most of the recent new DL materials are being used in micro fuel cells. 

While spectral analyzers systems as described above have served their purpose for several decades as process instrumental solutions, today s complex problems and environments necessitate practical and sophisticated sensors or similar compact process instruments. The electronic revolution over the last several decades has resulted in numerous microelectro-optical devices such as cell phones, PDAs and iPods. These... 

Instrnmentation for UV-vis process analysis falls into fonr categories scanning instruments, diode-array instrnments, photometers, and fiber-optic spectrophotometers with photodiode-array (PDA) and charge-conpled device (CCD) detectors. The former two are more typically enconntered in at-line or near-line applications, whereas the latter two are better snited to actnal on-line analyses. 

Personal electronic or electrical devices that may require control are pagers, cellular phones, personal digital assistants (PDAs), and personal radios or music players. Few, if any, of these devices are evaluated to determine if they may be safely used in hazardous areas. Typically, such devices do not claim to be "intrinsically safe" or of "nonincendive circuit" design (NFPA 70, Articles 500 and 504). 

Reverse-phase columns with a gradient elution in combination with UV-Vis spectrophotometers using photodiode-array (PDA) (Fig. 1.6) and spectrofiuorimeters are common devices employed in this technique. In a lesser extent, MS, tandem mass spectrometry (MS-MS), and nano liquid chromatography-electrospray ionization-quadrupole time-of-flight tandem mass spectrometry (nanoLC-nanoESI-Q-qTOF-MS-MS) has been used as detection system. This instrumentation has been mainly used in the analysis of dyes and proteinaceous media, and in some extent, in the analysis of drying oils and terpenoid varnishes [47,48],... 

Brose D, Cates S, Hutchison A. Studies on the scale-up of microfiltration membrane devices. PDA J Pharma Sci Technol 1994 48(4) 184-188. 

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