Definition Withdrawal
“We`re paying the price for inaction and we`re paying the price for withdrawal,” McCain said. Sinjar`s first-hand reports paint a picture of retreat without struggle and without warning from the local population. Their withdrawal of support forced the official to resign. Withdrawal occurs when you withdraw something, such as a withdrawal from your bank account. The withdrawal from Sector D leaves several other border crossings open. Withdrawal from the patient may be a sign of depression. The definition of “health risk” under 21 CFR 806 follows the definitions of Class I and II recalls in 21 CFR 7.3(m). Therefore, correction and withdrawal reports are required for Class I and II recalls. Under 21 CFR 806, manufacturers and importers are not required to report events classified as Class III recalls under 21 CFR §7; Only record-keeping obligations would apply. The word remove comes from Middle English and always means to draw or take back, as if you were withdrawing your hand when holding someone`s hand. A new definition of withdrawal is to stay away from others or stop participating in something. You can withdraw from society by hiding in your home, or withdraw from school by dropping out of school. Another way to withdraw is to promise to do something, but then change your mind.
A company may choose to recall a product if it is notified by the FDA that the agency has determined that the product in question is in violation of the law, but the agency has not specifically requested a recall. A company initiating a withdrawal or correction of its product that it considers to be a withdrawal from the market should consult its Democratic Republic of the Congo if the reason for the withdrawal or correction is not obvious or clearly understood, but if it is obvious, for example, due to complaints or side effects related to the product, that the product is defective in any respect. In such cases, the FDA will help the company determine the exact nature of the problem. His retreat from the life of his time was, in his verses, the act of a natural hermit. Recall means the removal or correction of a marketed product by a company that the FDA says violates the laws it administers and against which the agency would take legal action, such as a seizure. The recall does not include withdrawal from the market or stock recovery. Rhyme Dictionary: Words that Rhyme with Retirement Of all the dilemmas that followed, the speed reserve gave him a power of retreat based on what he was right to do. He announced a retreat from the French coast due to invincible enemy resistance. This opinion began to form between 1825 and 1830, after the retirement or withdrawal of eyewitnesses. But while such sanctions can be painful, they can also make Putin more adamant about withdrawing from Ukraine. Withdrawal from the market means the removal or correction of a product distributed by a company that involves a minor violation that would not be the subject of a lawsuit by the FDA, or that does not involve a violation, such as normal warehouse rotation practices, routine equipment adjustments and repairs, etc. After our army withdrew, General Price returned to Springfield and went to the winter quarters.
He has just announced the withdrawal of his resignation. When you announced that you would no longer run for president, your withdrawal from the race disappointed your many supporters. Withdrawal is also used to describe the painful experience that occurs when you stop taking an addictive drug (when you “remove” it from your system). The state of emotional detachment is called withdrawal. When a country terminates an agreement such as a treaty, it is also a withdrawal. Remember that retirement ends with “wal” and not just “wl”. A misunderstanding between the trio led to the withdrawal of the two doctors before the completion of the structure. Please note that an electronic product that emits radiation and is subject to 21 CFR 1003 and 1004 is not subject to the requirements of 21 CFR 7.
The report must be submitted to the FDA within 10 business days of the time the company initiates the correction or deletion. If there is no “health risk,” a report to the FDA is not required, but the manufacturer or importer must keep a record of the correction or removal. Recipients who receive a recall notice must immediately follow the instructions given by the recalling company and, if necessary, extend the recall to their recipients in accordance with the instructions described above. Manufacturers and importers must keep records of these corrections and withdrawals, which do not need to be reported to the FDA. However, if a report is not required under 21 CFR 806, the Company may voluntarily report under 21 CFR 7. Health risk means (1) a reasonable probability that the use or exposure to the product will result in serious adverse health or death consequences; or (2) the use of or exposure to the device may have temporary or medically reversible adverse health consequences or an outcome where the likelihood of serious adverse health effects is low. Such removal or correction will only be considered a recall if the FDA determines that the product is in violation of the product. In such cases, the FDA will request the Company to provide such information: The FDA will review the submitted information, inform the Society of the assigned recall classification, recommend appropriate changes in the Company`s recall strategy, and inform the Company that its recall will be included in the FDA`s weekly enforcement report. Until such review is completed, the Company does not need to delay the start of the withdrawal or correction of the product. Recall status reports should be discontinued when the recall is terminated by the FDA. Join our community to access the latest language learning and assessment tips from Oxford University Press! If the FDA, after giving the data subject an opportunity to consult with the Agency, determines that there is a reasonable likelihood that a product intended for human use will have serious and adverse health or death consequences, the FDA may issue a cease distribution order and notification requiring that the person named in the order: Immediately The person named in the order has the opportunity to conduct a regulatory hearing or make a written request to the FDA requesting that the order be amended, rescinded, or supplemented.
The FDA may later change the order to require a recall of the device. The recall company is the company that initiates a recall or, in the case of a recall requested by the Food and Drug Administration, the company that has primary responsibility for the manufacture and marketing of the product to be recalled. The words that defined the week of December 21, 2018 A company may choose to withdraw or correct a distributed product for any reason and under any circumstances. If a company does so because it believes its product is against the law, it must immediately notify the FDA. You should contact the Division Recall Coordinator (DRC) of your FDA`s Office of Regulatory Affairs (ORA), which is listed here by state or region (search by product type “medical device”). Foreign manufacturers and importers should contact the Democratic Republic of Congo, where their U.S. representative is located. The following actions are exempt from reporting requirements: You have two options for reporting corrections and deletions: FDA electronic submission software (eSubmitter) or email.
A recall strategy addresses the following with respect to the execution of the recall: Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7.
