№ lp_2_1_20420
File format: docx
Character count: 5471
File size: 31 KB
Guidelines for submitting eCopy versions of medical device premarket submissions to the FDA, detailing requirements such as formatting, cover letter inclusion, and submission portals for approval.
Year:
2019
Region / city:
USA
Topic:
Medical Device Submissions
Document Type:
Instructional Guide
Organization:
FDA (Food and Drug Administration)
Author:
FDA
Target Audience:
Medical Device Manufacturers, Regulatory Affairs Professionals
Action Period:
Since January 1, 2013
Approval Date:
December 13, 2019
Amendment Date:
Not specified
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / city:
United States
Topic:
Clinical research, FDA IND/IDE, Regulatory compliance
Document type:
Checklist
Organization / institution:
National Institute of Mental Health (NIMH)
Author:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
Not specified
Platform:
Intel Edison
Development Environment:
Arduino IDE 1.6.5
Programming Language:
Arduino (C/C++ based)
Network Configuration:
Custom HTTP port 1000
Referenced Examples:
WiFiWebServer Arduino example
Hardware Inputs:
Digital pins 2, 4, 6, 8
Primary Functionality:
Webpage hosting with background computations
Port Restrictions:
Avoid ports 22, 23, 80, 443
Update Mechanism:
Polling (with suggested interrupt-based improvement)
Type of Document:
Technical implementation notes
Document Type:
Institutional Review Board (IRB) checklist
Subject:
Criteria for approval of research involving an abbreviated Investigational Device Exemption (IDE)
Related Document:
HRP-314 - WORKSHEET - Criteria for Approval
Applicable To:
IRB Chairs, Vice Chairs, designees, Research Compliance Administrators
Purpose:
Documentation of regulatory determinations and protocol-specific findings
Scope:
Initial reviews, modifications, and continuing reviews with changed determinations
Responsible Office:
IRB Office
Key Topics:
Significant Risk Device Study; Non-Significant Risk Device Study; Risk determination rationale
Regulatory Basis:
Applicable federal regulations governing investigational device studies
Record Retention:
Maintained in the protocol file
Year:
2026
Topic:
Programming, Debugging, IDE Usage
Document Type:
FAQ Guide
Organization:
HackerEarth
Target Audience:
Programmers, Developers, Coding Contest Participants
Document URL:
https://www.hackerearth.com/docs/wiki/developers/solution-guide/
Context:
FAQ source explaining common runtime errors, compilation versus submission differences, and IDE troubleshooting tips for programmers.
Title:
Programming Worksheet on Syntax Highlighting, Prettyprint Formatting, and IDE Features for GCSE Programming Study
Subject:
Computer Science
Topic:
Syntax Highlighting, Code Formatting, Integrated Development Environments
Educational Level:
GCSE
Document Type:
Programming Worksheet
Structure:
Multi-task exercise sheet
Tasks Included:
Syntax highlighting analysis, code formatting (prettyprint), IDE feature comparison, code translation and testing
Programming Languages Mentioned:
Pseudocode, C#
Key Concepts:
Variables, strings, keywords, code readability, debugging features
Programming Tools Referenced:
IDE code editor features
Student Activities:
Code analysis, explanation questions, table completion, practical IDE testing, screenshots of IDE functionality
Year:
2017
Region / City:
Ide, Devon, United Kingdom
Organisation:
Ide Parish Council
Related Site:
Weir Meadow
Document Type:
Terms of Reference
Approval Date:
19 July 2017
Version:
v.2
Working Group:
Weir Meadow Working Group (WMWG)
Subject:
Development and management planning for a village sports and recreational facility
Associated Plan:
Ide Neighbourhood Plan (Policy IDE05)
Proposed Funding Sources:
Community Infrastructure Levy (CIL), National Lottery, local fundraising, Sport England, Football Association
Membership Limit:
Maximum 12 members including at least one Parish Councillor
Meeting Frequency:
Every two months after 6pm
Initial Mandate Period:
18 months
Year:
2025
Region / City:
Ide
Theme:
Community Orchard Management
Document Type:
Meeting Minutes
Organization / Institution:
Ide Parish Council
Author:
Mark Thomas (Chair)
Target Audience:
Members of Ide Community Orchard Management Group, local community
Period of Action:
November 2025
Approval Date:
27 November 2025
Date of Changes:
N/A
Year:
2026
Region / City:
United States
Topic:
Federal procurement and contract management
Document Type:
Policy/Guidance
Agency / Institution:
GSA (General Services Administration)
Author:
GSA
Target Audience:
Contractors, Government Agencies
Period of Validity:
Ongoing
Approval Date:
N/A
Modification Date:
N/A
Year:
Not specified
Region / City:
Not specified
Topic:
Corporate Experience, Relevant Project Experience
Document Type:
Solicitation Guidelines
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Contractors, Offerors
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Topic:
KiwiSaver, default provider, investment mandate, responsible investment
Document type:
Submission template
Institution:
Rural Clinical School Research Centre
Document type:
Research proposal outline
Intended use:
Preliminary presentation of a research idea
Target audience:
Prospective clinical and health researchers
Scope:
Clinical and health research projects
Geographic context:
Australia
Recommended length:
Three to five pages
Required sections:
Title, Background, Aims, Research Question, Research Plan, Dissemination, Project Team, Budget, Timeframe, References
Disciplinary focus:
Medical and health sciences
Year:
2023
Region / City:
United States
Subject:
Foreign Diplomatic Services Applications
Document Type:
Official Statement
Organization:
U.S. Department of State
Author:
U.S. Department of State
Target Audience:
Foreign diplomatic missions, foreign mission personnel
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Author:
Christopher Sidoti
Document type:
Public submission
Submission reference:
SSD 7056
Related application:
Amended Development Application
Date:
16 June 2016
Location of author:
Rosebery, New South Wales
Site concerned:
Campbell’s Stores, Campbell’s Cove, Hickson Road, Sydney Harbour
Position:
Objection to proposed new building
Consent to publication:
Granted
Political donations:
None declared
Year:
2026
Region / City:
California
Topic:
Forestry, Wildlife Conservation, Timber Harvesting
Document Type:
Guidance Document
Organization:
California Department of Forestry and Fire Protection (CAL FIRE)
Author:
Not specified
Target Audience:
Registered Professional Foresters (RPFs)
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Contract Year No.
Supplier:
Legal Name of Supplier
Facility:
Name of Facility
Contract:
Contract Title / Contract ID
Contract Date:
Contract Date
Time Period:
From insert date To insert date
Contract Capacity (MW):
Contract Capacity
Planned Outages:
As specified per unit and month
Unplanned Outages:
Percentage per unit and month
Overall Availability:
Percentage per unit and month
Type of Document:
Prescribed Form – Annual Operating Plan
Audience:
Buyer and Contract Management
Source:
Independent submission under Section 14.3(b)(i) of the Contract
Year:
2021
Region / City:
United States
Theme:
Housing survey, data collection
Document Type:
Government report
Agency / Organization:
U.S. Department of Housing and Urban Development (HUD)
Author:
U.S. Department of Housing and Urban Development (HUD)
Target Audience:
U.S. government officials, policy makers, researchers
Period of validity:
2021
Approval Date:
Not specified
Date of amendments:
Not specified
Year:
2025
Region / city:
Victoria
Subject:
Animal welfare, scientific research, animal use reporting
Document type:
Guideline
Agency:
Animal Welfare Victoria
Author:
Animal Welfare Victoria
Target audience:
License holders of scientific procedures and animal breeding
Period of validity:
2025
Approval date:
2025
Amendment date:
N/A
Note:
Year
Theme:
Construction and Engineering Documentation
Document Type:
Submission Guidelines
Organization / Institution:
Department of Veterans Affairs (VA)
Target Audience:
Architects, Engineers, VA Medical Center Personnel