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Notifications, process

Two statutory provisions of Tide 21 govern the introduction of new medical devices into the marketplace. Section 515 estabHshes a premarket approval appHcation (PMA) containing data and information demonstrating the safety and effectiveness of a device. Section 510(k) estabHshes a premarket notification process. Under this process, a manufacturer is required to file with the EDA, 90 days before a new device is to be marketed, a premarket notification demonstrating that the device in question is substantially equivalent to a device that was on the market before enactment of the 1976 Amendment and therefore marketable without formal EDA approval. [Pg.177]

The 510(k) pre-market notification process is not as onerous as the pre-market approval procedure, as clearance to market a device is not based on actual assessment of the safety and effectiveness of the particular device in question. Instead, devices can be cleared on the basis that they are substantially equivalent to existing devices that have been recognised as safe and effective, or that they conform to specific device standards promulgated or recognised by the FDA. There are four procedural variations to the 510(k) notification process. [Pg.202]

Notification processes hinder new product and process development Potential for reducing costs... [Pg.292]

The Safe Medical Devices Act of 1990, a major revision to the 1976 amendments, among other revised requirements provided two major mechanisms for bringing an IVD medical device to market premarket notification and premarket approval. The act is administered by the FDA s Center for Devices and Radiological Health, of which the Division of Clinical Laboratory Devices (DCLD) is a part. The premarket notification process is used for devices that can be classified... [Pg.171]

It is explained that the Food Contact Notification process of the US Food Drug Administration has been in place officially for three months This article asks, and then strives to answer, many questions about the system. [Pg.76]

Medium and small size chemical companies are likely to be more severely impacted by the notification requirements than larger companies. The reasons are that smaller companies are less likely to be willing to cope with the uncertainties and costs of the notification process and will be less able to take on the higher risks of R D."... [Pg.38]

Instead of the formal GRAS affirmation petition, the FDA initiated a new procedure for GRAS ingredients, the GRAS notification. Under the notification process, a... [Pg.46]

Lead CRA—The lead contract research associate is usually responsible for interfacing with field monitors and addressing investigator non-compliance. They review field reports provided by field staff- and determine adequate follow-up to problems that have been identified by the field staff"as well as investigators. Clinical QA must ensure that the lead CRA is adequately trained to respond comprehensively and in a timely manner. It must also be formally trained on the notification process required when patient safety or data integrity is in question. [Pg.506]

More recently, several new notification categories have been introduced under the Low Regulatory Concern Chemicals (LRCC) initiative [5]. These changes to the scheme have been introduced in order to streamline the notification process, reduce the regulatory burden on... [Pg.271]

The next step was a regulatory requirement on those who generated, treated, stored, or disposed of wastes to send in to the State notifications identifying the wastes covered as hazardous wastes by the State regulations. This notification process tended to produce rather conservative identifications of wastes that is, notifiers tended to identify as hazardous wastes a broader spectrum of wastes than have so far been identified as hazardous by EPA. The universe of hazardous wastes regulated in Louisiana has been larger than that under... [Pg.12]

It is always difficult to find a suitable shipping conpany for transporting hazardous waste. They fear problems from environmental groups as well as problems during stopover in a third country. Under the Basel Convention there is an established notification process to inform third countries in advance about the transport of hazardous waste, but some governments do not want foreign waste to pass through their territory. [Pg.51]

Within the FDA s Center for Food Safety and Applied Nutrition, the Office of Food Additive Safety administers premarket approval processes for new direct food additives and food additives that are components of food contact materials. Most food contact materials are regulated via the food contact notification process and authorization of new food contact materials is administered by the Division of Food Contact Notifications (see Chapter 2 for further information). The notifier has the primary responsibility to demonstrate the safety of the proposed use of the food contact material. Review scientists within FDA perform a fair evaluation of the data in a food contact notification, as well as other relevant information, to determine if the knowledge base supports the finding with reasonable certainty that no harm will result from the intended use of the food additive. FDA maintains a number of public online listings that include useful information... [Pg.158]

As discussed above, the Delaney clause applies to substances proposed for use as food additives, but does not apply to individual constituents of a food additive. Examples of constituents would include residual monomers or catalysts. The constituents policy, subjected to judicial review in Scott v. FDA, 728 F. 2d 322 (6th cir. 1984), states that FDA may consider the potential risks of constituent exposure under the general safety standards set forth in FFDCA. The notification process places the responsibility upon the notifier for addressing the carcinogenic risk of constituent exposure from a proposed use of a food additive. FDA recommends that notifiers include in their food contact notification a safety narrative that addresses the safety of each carcinogenic constituent at any exposure (in addition to the recommendations listed in Table 7.1). This narrative should include an estimate of the potential human cancer risk from the constituent due to the proposed use of the food contact material (FDA, 2002). [Pg.166]

The legal prerequisites for the conduct of clinical trial and the clinical trial notification process should be followed when conducting clinical trial. [Pg.786]

There is no way to answer this question in a general vray. Since ionic hquids can consist of so many chemically different types of cations and anions this question has to be answered case by case. The magic ionic hquid which meets all requirements in toxicity, ecotoxicity, stability and performance simply does not exist. Up to now there is still very limited information available regarding a full toxicological profile of ionic liquids. However, recently some valuable data have been published [27]. These data were collected for the notification process of the corresponding ionic liquids and represent examples from the most common classes of cations EMIM, BMIM and ammonium (Table 9-3). [Pg.683]

If the company frequently exports many different products containing chemical substances subject to the export notification requirements, a manual check will likely not be the optimal way to ensure compliance. A preferable approach would be to insert flags in the company s enterprise resource planning system, its order processing system, or its export system that alert the export speciahst that a particular product being exported is subject to an export requirement. The export speciahst can be trained to pass this information on to the regulatory specialist, who wiU handle the notification process. Or, the... [Pg.282]

Like the PMN process, the significant new use notification process enables the EPA to evaluate the risks that may be presented by a new use of a substance and gives the EPA an opportunity to gather risk data and regulate the use if it may present unreasonable risks. [Pg.391]

The notification process is distinct from training it concerns those people who have some peripheral involvement with the consequences of the change, but who are not directly affected by it. In the case of the Standard Example, the operators and instrument technicians will need to be trained regarding the operation of Tank T-101 if the instrumentation associated with it is modified. However, the administrative personnel and people at corporate headquarters need only be notified (Figure 10.11). [Pg.442]

Confidentiality is maintained with respect to the patient and the providers who were involved, but a case study is created to inform others about the risks and lessons learned so that greater resilience can be introduced to prevent error from reaching a patient again. The analysis is introduced to participants through the introductory protocol shown in Exhibit 7.1. In addition, protocols (described in the following sections) have been developed for explicit guidance of the notification process after a medical accident. [Pg.151]

The committee reviewed U.S., Canadian, and European laws and regulations to examine current processes for manufacturers who wish to add new ingredients to infant formulas a GRAS Notification and a Food Additive Petition. The committee drew on this review, especially the GRAS Notification process, as it developed its recommendations. The committee also reviewed the special needs of infants and their implications for evaluating the safety of infant formulas. [Pg.2]

By contrast, the GRAS Notification process requires that the manufacturer make the initial declaration of the safety of the product based on consensus by qualified experts. FDA then reviews the notification and, if all of its questions are satisfactorily answered, the agency issues a letter of no objection. Because this process has become the primary route of introduction of new ingredients to infant formulas, the GRAS Notification process is reviewed in greater detail in Chapter 4. [Pg.35]


See other pages where Notifications, process is mentioned: [Pg.202]    [Pg.146]    [Pg.151]    [Pg.153]    [Pg.47]    [Pg.49]    [Pg.56]    [Pg.1]    [Pg.161]    [Pg.445]    [Pg.1780]    [Pg.1948]    [Pg.169]    [Pg.161]    [Pg.47]    [Pg.49]    [Pg.56]    [Pg.40]    [Pg.274]    [Pg.75]    [Pg.27]    [Pg.5]    [Pg.444]    [Pg.3]    [Pg.3]    [Pg.6]   
See also in sourсe #XX -- [ Pg.331 ]




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