Download Free The Reports Clearance Process Book in PDF and EPUB Free Download. You can read online The Reports Clearance Process and write the review.

Perhaps you are one of the many who have questions about getting a US security clearance. Maybe you are interested either as an employee or business owner in getting a security clearance, but don't know how to get started. This book is written with you in mind and is addressed specifically for defense contractors operating under the Department of Defense guidance. Other Government agencies may have different procedures. However, this book can be used as a general reference regardless of which agency the contractor is operating under. This book reflects requirements as found in the National Industrial Security Program Operating Manual (NISPOM).
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Efforts to reform personnel security clearance processes should consider, among other things, the following four key factors: (1) a strong requirements-determination process, (2) quality in all clearance processes, (3) metrics to provide a fuller picture of clearance processes, and (4) long-term funding requirements of security clearance reform. In February 2008, GAO noted that a sound requirements process is important because requesting a clearance for a position in which it will not be needed, or in which a lower-level clearance would be sufficient, will increase both costs and investigative workload unnecessarily. For example, the cost of obtaining and maintaining a top secret clearance for 10 years is approximately 30 times greater than the cost of obtaining and maintaining a secret clearance for the same period. Also, changing a position's clearance level from secret to top secret increases the investigative workload for that position about 20-fold.
Security Clearance Manual is an indispensable guide for security clearance applicants, personnel security specialists and military recruiters. It provides detailed explanations of the investigative and adjudicative processes with step by step instructions for completing the security application form, tips on mitigating suitability issues and numerous case examples.
In 2004, Congress passed the Intelligence Reform and Terrorism Prevention Act to reform security clearance processes. The experience in evaluating personnel security clearance processes has consisted of examining the DoD program, which maintains 2.5 million clearances on service members, DoD civilian employees, legislative branch employees, and industry personnel working for DoD and 23 other fed. agencies. Long-standing delays in processing applications -- and other problems in DoD¿s clearance program -- led it to be designated a high-risk area in 2005. There has also been clearance-related problems in other agencies. Here, the author was asked to identify key factors that could be applied in personnel security clearance reform efforts.

Security Clearance Reform

United States. Congress. House. Permanent Select Committee on Intelligence. Subcommittee on Intelligence Community Management

Published: 2008

Total Pages: 86


Get eBook