a specific general


In 1850 there was A SERIOUS OUTBREAK OF CHOLERA (13) in Jamaica. Since he didn’t have this specific intent, Joe cannot be convicted of the crime. All written comments should be identified with this document's docket number: FDA-2020-D-0957.
General indication for use-Quantitative measurement of Factor VII in patients with known or suspected Factor VII deficiency (identifying or assessing a group of people with a rare genetic disorder), Specific indication for use- Factor VII assay as a predictive marker for stroke (using the same test on a significant number of asymptomatic adults at risk for stroke). It originates in the 16th century, as a shortening of captain general, which rank was taken from Middle French capitaine général. The Senate committee report which preceded the final FDAMA bill stated that "this clarification [with respect to general/specific use] is important because FDA has not established a consistent pattern upon which persons who submit premarket notifications may rely." The skills needed to write range from making the appropriate graphic marks, Conversely, when does a specific indication for use become a new intended use that requires submission of a PMA to establish the safety and effectiveness of the device? A second example, cited in Blue Book Memorandum #K86-3, relates to powered suction-aspiration devices, which were initially cleared to remove tissue and fluid from the body during surgery. The specific-to-general pattern reverses the one we just discussed. Level of specificity: The change from a general use (evaluating soft tissue) to a specific recommendation to biopsy or not to biopsy is a significant change. as the general-to-specific pattern. If Joe punches John in the face after John says something offensive and breaks his nose, John most likely committed battery. LearnEnglish Subscription: self-access courses for professionals, © British Council Nor does this guidance construct a new or separate SE/NSE decision-making process. One important aspect of this last feature When HER MOTHER (9) died, Mary took over THE BOARDING HOUSE (10) and THE CARE (11) of … Learn how and when to remove this template message, General of the Armies of the United States, 幕僚長たる陸将(Rikushō serving as Chief of Staff), Bios & Information on Generals of Western History, Marshal of the Mongolian People's Republic, https://en.wikipedia.org/w/index.php?title=General_officer&oldid=985705880, Articles containing Portuguese-language text, Articles containing Bulgarian-language text, Articles containing Spanish-language text, Articles containing Chinese-language text, Articles containing Estonian-language text, Articles containing Finnish-language text, Articles containing Georgian-language text, Articles containing Persian-language text, Articles containing Indonesian-language text, Articles containing Italian-language text, Articles containing Japanese-language text, Articles containing Macedonian-language text, Articles containing Malay (macrolanguage)-language text, Articles containing Norwegian-language text, Articles containing Filipino-language text, Articles containing Vietnamese-language text, Articles containing Swedish-language text, Articles containing Tagalog-language text, Articles with dead external links from April 2018, Articles with permanently dead external links, Short description is different from Wikidata, Articles needing additional references from June 2011, All articles needing additional references, Articles containing Russian-language text, Creative Commons Attribution-ShareAlike License, Wing general and group general (Mexican Air Force; roughly equivalent to, Director general (a common administrative term sometimes used as an appointment in military services), Director general of national defence (most senior rank in the Mexican Armed Forces), This page was last edited on 27 October 2020, at 13:41. This latter group includes the British Royal Air Force and many current and former Commonwealth air forces—e.g. We use a specific determiner when we believe the listener/reader knows exactly what we are referring to: Can you pass me the salt, please? Example: Auto theft is defined as the act of taking a car with the intent to deprive the owner of it permanently. The general officer ranks are named by prefixing "general", as an adjective, with field officer ranks, although in some countries the highest general officers are titled field marshal, marshal, or captain general. Specific uses that ordinarily fall within a general use for the purpose of determining that the device with the specific indication for use is substantially equivalent to the general use device include: Specific indications for use that ordinarily fall outside a general use for the purpose of determining substantial equivalence include: The following are examples of Agency determinations with respect to 510(k) submissions made for purposes of establishing the substantial equivalence of a new device labeled with the specific indication for use to the legally marketed device labeled for the general use. The specific controls over the general. General indication for use- Ablation of soft tissue in urology, Specific indication for use- Treatment of prostate cancer. Some of these submissions require clinical data before clearance. FDA has issued guidance documents that describe the process by which substantial equivalence decisions are rendered. The 510(k) review process requires the agency to determine the proper classification for a medical device. through utilizing the resources of the chosen language, to anticipating the See more.
As adjectives the difference between specific and general is that specific is explicit or definite while general is including or involving every part or member of a given or implied entity, whole etc; as opposed to (specific) or (particular). Not limited to a specific class; miscellaneous, concerned with all branches of a given subject or area. The criteria that follow are provided as guidance on the Agency’s decision-making process for determining substantial equivalence or non-equivalence for general/specific uses. However, different countries use different systems of stars or other insignia for senior ranks. Public health impact: Because prostate cancer is a common and lethal cancer in men, a device cleared for treatment of that disease would have a significant public health impact. The new indication for use established a use that is qualitatively different from other indications for ultrasound.

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