№ lp_1_2_55861
File format: docx
Character count: 75545
File size: 4762 KB
Year:
2018
Region / City:
International
Topic:
Medical Device Identification
Document Type:
Application Guide
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF UDI WG
Target Audience:
Medical device regulatory authorities, manufacturers, healthcare stakeholders
Period of validity:
Not specified
Approval Date:
12 July 2018
Date of Changes:
Not specified
Context:
This document provides a detailed guide on implementing a harmonized Unique Device Identification (UDI) system for medical devices to aid regulatory authorities, manufacturers, and stakeholders in the healthcare supply chain.
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Year:
2018
Region / city:
International
Topic:
Medical device regulation
Document type:
Proposed document
Organization / institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF UDI WG
Target audience:
Medical device regulators
Period of validity:
Ongoing
Approval date:
12 July 2018
Date of changes:
None
Year:
2013
Region / city:
Global
Topic:
Medical Devices, UDI System
Document Type:
Guidance
Organization / Institution:
IMDRF
Author:
IMDRF UDI Working Group
Target Audience:
Regulatory authorities, healthcare professionals, manufacturers
Period of validity:
Not specified
Approval date:
9 December 2013
Date of revisions:
Not specified
Year:
2026
Region / Country:
United States
Subject:
Medical and dental device labeling and regulatory compliance
Document Type:
Standard Operating Procedure (SOP)
Organization:
Carestream Health
Author:
Regulatory Affairs Department
Target Audience:
Project teams, business managers, regulatory and purchasing personnel
Effective Period:
Indefinite until updated
Approval Date:
2026-03-12
Revision Date:
Not specified
Scope:
Devices, items, and parts requiring Unique Device Identifier (UDI) under FDA regulations
Procedures Included:
Labeler determination, documentation requirements, contractual responsibilities
Device Types:
Electronic and non-electronic medical devices
) and join the S1NET. For guides with in depth examinations of performance measure definitions, go to:
https://www.milsuite.mil/book/docs/DOC-129783
Table of Contents (Hyperlinks to Sections):
Developing ‘Significant Duties and Responsibilities’ OER Narratives: Notes, Rules, and Instructions OER Narrative Prohibited Techniques, Inconsistencies, No-Go’s: Negative Comment Rules Referred OERs Narrative Comment Examples Block a. APFT and HT/WT Block b. Overall Performance Block c. Character (to include SHARP comments) Block d. Presence Block e. Intellect Block f. Leads Block g. Develops Block h. Achieves Senior Rater Potential Senior Rater Narrative Examples Senior Rater Narrative Comment Examples (for potential, promotion, school, etc.) Successive Assignments Other SR Comments (explanations of anything unusual about OER) Effective Words for Evaluations JUNIOR OFFICER PLATE (DA FORM 67-10-1) NOTE: 2LTs who have NOT completed BOLC, will not receive an OER until they complete BOLC (AC and ARNG; USAR officers can receive an OER before completing BOLC). The FROM date will be their commissioning date. All time until their BOLC graduation will be NONRATED on their first OER. OER PROFILING: OERs: Rater and Senior Rater Profiles are CONSTRAINED, meaning Officers are only allowed to grant 49% of each rank they rate with either an “EXCELS” (as Rater) or “MOST QUALIFIED” (as Senior Rater). HOWEVER, if you have an immature profile, and have only just begun rating/senior rating Officers of a certain rank, you are allowed a ONE TIME option of giving one of the first two evaluations you make at a particular grade, an “EXCELS” (as Rater) or “MOST QUALIFIED” (as Senior Rater). OER (OER SUPPORT FORM) PART III: Developing ‘Significant Duties and Responsibilities’ (blocks a., b., and c.): Refer to DA PAM 611-21 (https://www.milsuite.mil/book/groups/smartbookdapam611-21
) and DA PAM 600-3 (Commissioned Officer Professional Development and Career Management), to assist in the development of PART III, block d. As a minimum, the duty description will include pr:
- Number of personnel supervised, - Amount of resources under the rated officer’s control, - Scope of responsibilities. 3) Descriptions must be clear and concise with emphasis on specific functions required. 4) Note conditions unique to the assignment; e.g. RA officers assigned to FT support duties with RC units or USAR officers assigned to RA units OER NARRATIVES: Notes, Rules, and Instructions Rater and Senior Rater Narratives: - Requires candor and courage; frank and accurate assessment. - Quantify officer’s value relative to peers and do so in concert with rater/senior rater box check. - Are short; tell a simple story about the quality of officer being evaluated. - Are interesting and compelling. - Are looked at by selection board members when they are looking for in-depth information about a rated officer’s performance and potential. - Numbers; 1-10, write them out (e.g. one, two, ten). 11 or higher, write the number; e.g. 11, 15, 105. Exception, when a 1-10 is WITH an 11 or higher; e.g. “5 tool kits with 20 tools each.” - Fashion the narrative to the officer; double check use of “he/his” vs. “she/hers.” - Awards: Awards and/or special recognition received during the rating period may be cited in evaluation comments (for example, “received the Humanitarian Service Medal” or “named the Instructor of the Year”). - Raters and SR CAN use the officer’s name in the narrative; e.g. “1LT Joe was ….” Rater and Rater Narratives: - Focus on PERFORMANCE; explaining what the rated officer did and how well he/she did it. - Focus on specifics to quantify and qualify performance. - Raters should advocate the rated officer to the SR. - When there is no SR (due to lack of qualifications), rater’s narrative provides the input on both performance and potential. Senior Rater (SR) and SR Narrative (see SR Rater Narrative section for examples): - Focus on POTENTIAL, 3-5 years out (promotions, command, school, & assignments). - Can amplify box checks by using the narrative to clearly send the appropriate message to selection boards. - CANNOT mention Box Check. - Additional information for when SR is also Rater can be found in DA PAM 623-3, pg. 26, “DA Form 67–10–1, part VI: block c—Senior Rater Narrative.” OER Narrative Prohibited Techniques, Inconsistencies, No-Go’s: - School/Course Comments: Bullets about how a Soldier did in a school or course are ONLY allowed if that school did not produce an AER/DA Form 1059. - Narratives are not a laundry list of superlatives – more is not necessarily better. - Brief, unqualified superlatives or phrases, particularly if they may be considered trite. - Excessive use of technical acronyms, or phrases not commonly recognized. - Techniques aimed at making specific words, phrases, or sentences stand out from the rest of the narrative; e.g. excessive use of capital letters; unnecessary quotation marks; repeated use of exclamation points; wide spacing between selected words, phrases, or sentences to include double spacing within a paragraph or between paragraphs. - Inappropriate references to box checks; e.g “Would be TOP BLOCK if profile allowed” or “absolutely far exceeded the standard”. - Trying to quantify (e.g. “top 2% of my captains”) with a small population. - Stay in your lane/level; avoid comments like “Best 1LT in the Army” unless you’re the Army CoS. - Stating “the best ever”; having 10 in the population, 50 in the profile. - Using overused phrases and clichés that are counterproductive or overused; e.g. stellar, historic, “delivered a dazzling performance,” “hit the ground running,” consummate professional, and unlimited potential. - Using specific selection board-type language. Examples of this include, “definitely a 6+ Soldier”. - Don’t exaggerate; “If I could prove it, CPT X is an LTC disguised as a CPT.” - Be mindful of what IS NOT said; it can have the same impact as what is said; e.g. NOT having numbers, or quantifiable points. - Don’t say the sa
Note:
en
Topic:
Officer Evaluation, Narrative Guidelines
Document Type:
Guide
Target Audience:
Raters, Senior Raters
Year:
2022
Region / City:
Wales
Topic:
Education
Document Type:
Recruitment Pack
Organization / Institution:
Estyn
Author:
Owen Evans, Her Majesty’s Chief Inspector of Education and Training
Target Audience:
Prospective applicants for the role of Her Majesty’s Inspector of Education and Training
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2022
Region / City:
United States
Topic:
Entity Registration, Federal Government
Document Type:
Fact Sheet
Organization / Institution:
Federal Government, SAM.gov
Author:
Unknown
Target Audience:
Organizations doing business with the Federal Government
Effective Period:
April 4, 2022
Approval Date:
Unknown
Amendment Date:
Unknown
Note:
Year
Document Type:
Proposal
Note:
(If there are multiple corresponding authors then nominate one for communication with the editorial office.)Received date; Revised date; Editorial decision date.
Year:
2024
Region / City:
CAISO Controlled Grid
Theme:
Energy Transmission, Interconnection Procedures, Resource Adequacy
Document Type:
Appendix to the CAISO Tariff
Agency / Institution:
CAISO
Author:
Not specified
Target Audience:
Interconnection Customers, Load Serving Entities
Validity Period:
2024-2025
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Contextual Description
Note:
Year
Topic:
Vocational Education and Training (VET), Education Policy
Document Type:
Factsheet
Organization / Institution:
Australian Government
Target Audience:
Parents, Students, Educational Institutions
Year:
2015
Region / City:
Australia
Topic:
Vocational Education and Training (VET), USI
Document Type:
FAQ
Author:
Australian Government
Target Audience:
VET students, Registered Training Organisations (RTOs)
Date of Approval:
Not specified
Date of Changes:
Not specified
Note:
Description
Year:
2022
Region / city:
United States
Topic:
Government transition to new entity identifier system
Document type:
Fact Sheet
Author:
Federal Government
Target audience:
Entities doing business with the Federal Government
Effective period:
From April 4, 2022
Approval date:
N/A
Amendment date:
N/A
Year:
2023
Region / City:
Alexandria, VA
Topic:
Transition to Unique Entity Identifier (UEI)
Document Type:
Memorandum
Issuing Agency:
Food and Nutrition Service (FNS), Child Nutrition Programs
Author:
Jessica Saracino, Lynn Rodgers-Kuperman
Target Audience:
Regional Directors, State Directors, Child Nutrition Program Operators
Effective Period:
April 2022 - Ongoing
Date of Approval:
March 20, 2023
Date of Changes:
N/A
Year:
2013
Region / city:
Global
Topic:
Medical Devices, UDI System
Document Type:
Guidance
Organization / Institution:
IMDRF
Author:
IMDRF UDI Working Group
Target Audience:
Regulatory authorities, healthcare professionals, manufacturers
Period of validity:
Not specified
Approval date:
9 December 2013
Date of revisions:
Not specified
Year:
2022
Region / City:
United States
Topic:
Federal award management, entity registration
Document Type:
Fact Sheet
Agency / Institution:
Federal Government
Author:
Not specified
Target Audience:
Entities doing business with the Federal Government
Validity Period:
April 4, 2022 - ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2014
Region / City:
N/A
Topic:
ITU-T, IEEE Standards, MAC Addresses, Protocol Identifiers
Document Type:
Technical Specification
Organization / Institution:
ITU-T
Author:
N/A
Target Audience:
Technical experts, network engineers, IEEE/ITU-T standard users
Period of Validity:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Context:
A technical document detailing the use of IEEE-assigned Organizationally Unique Identifier (OUI) for generating MAC addresses and protocol identifiers as per IEEE and ITU-T standards.
Year:
2014
Organization:
ITU-T
Type of document:
Technical specification
Standard references:
IEEE Std 802TM-2014, IEEE Std 802.3TM-2012, IEEE Std 1588TM-2008
Scope:
Local and Metropolitan Area Networks, MAC addresses, Protocol Identifiers, Slow Protocols, OAM, MAC Control, IEEE 1588 profiles
Assigned OUI:
00-19-A7
Protocol subtypes:
OMCI, Backchannel Data, SSM, BACP
Document format:
Technical frames and tables with octet-level specifications
Year:
2015
Region / City:
St. Louis
Topic:
Veterans Affairs, Claims, Military Records
Document Type:
Policy Guidelines
Authority:
National Personnel Records Center (NPRC)
Target Audience:
Veterans Affairs Claims Processors
Effective Period:
Ongoing
Approval Date:
March 23, 2015
Change Date:
March 23, 2015
Keywords:
Veteran Records, Fire Destruction, Medical Records, Service Treatment Records, PIES Requests, Claim Processing
Year:
2020
Region / City:
Rochester, MN
Topic:
Cybersecurity of medical and research devices
Document type:
Vendor packet
Organization / Institution:
Mayo Clinic
Author:
Mayo Clinic
Target audience:
Vendors, healthcare technology management teams
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2025
Region / city:
EU
Topic:
Health Technology Assessment
Document Type:
Guidance
Organization / Institution:
HTA CG
Author:
European Commission
Target audience:
Professionals in Health Technology Assessment
Validity period:
From 28 NOVEMBER 2025
Approval date:
28 NOVEMBER 2025
Amendment date:
Not specified