№ files_lp_3_process_7_101705
File format: docx
Character count: 11096
File size: 42 KB
Web page update from the Center for Devices and Radiological Health outlining eligibility criteria, submission procedures, statutory framework, and review timelines for Small Business Determination requests under the Medical Device User Fee Amendments of 2022.
Year:
2024
Update date:
July xx, 2024
Effective date:
August 1, 2024
Fiscal Year referenced:
Fiscal Year 2025
Country:
United States
Issuing authority:
U.S. Food and Drug Administration
Center:
Center for Devices and Radiological Health (CDRH)
Program:
Small Business Determination (SBD) Program
Related legislation:
Medical Device User Fee Amendments of 2022 (MDUFA V)
Subject:
Qualification and certification of small businesses for reduced medical device user fees
Eligibility criteria:
Gross receipts and sales less than $100 million for the most recent tax year; first premarket application/report waiver for businesses with gross receipts or sales no more than $30 million
Application method:
Electronic submission through the Customer Collaboration Portal (CDRH Portal)
Review timeline:
Within 60 calendar days of receipt
Fee for determination request:
No fee
Eligible submission types:
510(k), De Novo request, PMA, BLA, PDP, PMR, PMA/BLA Supplements, PMA Annual Reports, 30-day notices, 513(g) request for classification information
Target audience:
Medical device businesses and affiliates seeking reduced user fees
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2017
Region / City:
South Africa
Topic:
Local Content, Procurement
Document Type:
Standard Bidding Document
Organization / Institution:
South African Bureau of Standards (SABS)
Author:
South African Government
Target Audience:
Bidders in South Africa
Period of validity:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2022
Jurisdiction:
South Africa
Legal framework:
Preferential Procurement Policy Framework Act, 2000 (Act No. 5 of 2000)
Regulations:
Preferential Procurement Regulations, 2022
Document code:
SBD 6.1
Document type:
Procurement form
Purpose:
Claiming preference points in public tenders
Applicable systems:
80/20 and 90/10 preference point systems
Tender scope:
Goods and services, income-generating contracts, disposal or leasing of state assets
Administering authority:
Organ of state
Evaluation criteria:
Price and specific goals
Maximum points:
100
Specific goals referenced:
B-BBEE status, local content and production, ownership by women, black youth, people living with disabilities
Required evidence:
B-BBEE certificates, sworn affidavits, CIPC documents, local content declarations, identity documents, medical reports
Document code:
SBD 8
Jurisdiction:
Republic of South Africa
Thematic area:
Public procurement
Subject matter:
Supply chain management compliance
Document type:
Standard bidding document
Issuing authority:
National Treasury
Related legislation:
Prevention and Combating of Corrupt Activities Act, 2004
Target audience:
Bidders to public sector institutions
Required submission:
Mandatory with bid
Time reference:
Past five years
Certification requirement:
Signed declaration by bidder
Year:
2021
Region / City:
Sri Lanka
Subject:
Contractor Financing
Document Type:
Report
Institution:
National Water Supply & Drainage Board
Author:
Technical Evaluation Committee (TEC)
Target Audience:
Procurement Committee, Contractors
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2016
Region / City:
United Kingdom
Subject:
Security standards for home design
Document Type:
Application form
Organization / Institution:
Secured by Design
Author:
Unknown
Target Audience:
Developers, architects, planning officers
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Document Code:
SBD 6.1
Country:
South Africa
Legislation Referenced:
Preferential Procurement Regulations, 2022; Preferential Procurement Policy Framework Act, 2000 (Act No. 5 of 2000)
Subject:
Public procurement and tender evaluation criteria
Document Type:
Government tender claim form
Issuing Authority:
Organ of state (not specified)
Purpose:
Claiming preference points for specific goals in public tenders
Applicable Preference Point Systems:
80/20 system; 90/10 system
Maximum Points Allocation:
Price – 80 or 90; Specific Goals – 20 or 10
Specific Goals Categories:
Historically disadvantaged individuals; Women; Persons with disability
Applicable Contract Types:
Procurement of goods and services; income-generating contracts; leasing or disposal of state assets
Required Declaration:
Certification of accuracy of claimed preference points and compliance with tender conditions
Required Company Information:
Company name; registration number; type of company or firm
Signature Requirement:
Authorized representative of the tendering company or firm
Year:
2024
Region / City:
United Kingdom
Topic:
Education
Document Type:
Guidance
Organization:
Children’s Services
Author:
Richard Woodard
Target Audience:
All Schools
Review Date:
August 2026
Date of Approval:
April 2024
Date of Changes:
Not specified
Context:
This document provides guidance for schools in the United Kingdom on the use of reduced timetables for pupils of compulsory school age due to non-disciplinary reasons, with an emphasis on legal frameworks, responsibilities, and best practices.
Year:
2024-2025
Region / City:
United States
Subject:
Education
Document Type:
Technical Guide
Institution:
U.S. Department of Education
Target Audience:
State educational agencies (SEAs), local educational agencies (LEAs)
Effective Period:
SY 2024-25
Approval Date:
June 2024
Revision Date:
September 2025
Year:
2023
Region / City:
United States
Topic:
Long-term care insurance rate increases
Document Type:
Report
Agency / Institution:
Long-Term Care Insurance (EX) Task Force
Author:
Reduced Benefit Options Workstream
Target Audience:
Policyholders, Regulators, Insurance companies
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Subject:
Education, Special Educational Needs
Document Type:
Position Statement
Organization / Institution:
Shropshire Council
Author:
Shropshire Council
Target Audience:
Schools, Education Professionals
Period of Effect:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2020
Region / city:
Greater Manchester & Eastern Cheshire
Subject:
Obstetrics, Fetal Health
Document Type:
Clinical Guidelines
Institution:
Manchester Academic Health Science Centre, University of Manchester
Author:
Alexander Heazell, Prof.
Target Audience:
Healthcare professionals, maternity care providers
Period of Validity:
01/05/2020 - 01/05/2022
Date of Approval:
01/05/2020
Date of Last Revision:
01/05/2020
Year:
2024
Region / City:
Brent
Topic:
Education
Document Type:
Guidance
Author:
Brent Local Authority
Target Audience:
Schools, Education Authorities
Period of Validity:
September 2024 onwards
Approval Date:
September 2024
Amendment Date:
N/A
Year:
2026
Region / city:
West Virginia
Topic:
Taxation, Property Tax, Levies
Document Type:
Bill
Institution / Organization:
West Virginia Legislature
Author:
Senators Smith and Hamilton
Target Audience:
Public officials, government organizations
Period of Validity:
2026
Date of Approval:
January 28, 2026
Date of Changes:
Not specified
Note:
Year
Theme:
Neuroscience
Document Type:
Research Article
Author:
Keith A. Misquitta, Amy Miles, Thomas D. Prevot, Jaime Knoch, Corey Fee, Dwight F. Newton, Jacob Ellegood, Jason P. Lerch, Etienne Sibille, Yuliya S. Nikolova, Mounira Banasr
Target Audience:
Researchers in neuroscience, psychology
Year:
2021
Region / City:
Electronic Meeting
Theme:
5G, NR RedCap, RAN1
Document Type:
Status Report
Organization:
3GPP TSG RAN
Author:
Johan BERGMAN
Target Audience:
Technical experts, 3GPP members
Period of Effect:
2021
Approval Date:
September 2021
Date of Changes:
Not specified
Year:
2018
Region / City:
Missouri
Subject:
Food and Nutrition Services
Document Type:
Policy Statement
Organization / Institution:
Missouri Department of Elementary and Secondary Education
Author:
N/A
Target Audience:
Local Education Agencies (LEAs), school administrators, and parents
Period of Validity:
Permanent upon approval
Approval Date:
N/A
Date of Amendments:
N/A
Note:
Year
Year:
2019
Region / City:
United Kingdom
Subject:
Education, School Attendance
Document Type:
Protocol
Organization / Institution:
Department for Education
Author:
Clive Haines
Target Audience:
Schools, Educational Authorities
Period of Validity:
Ongoing
Approval Date:
December 2019
Amendment Date:
July 2024
Year:
2026
Region / City:
Global
Topic:
Cloud computing
Document type:
Article
Organization / Institution:
McKinsey
Author:
McKinsey & Company
Target audience:
Business leaders, technology executives
Period of validity:
Indefinite
Date of approval:
2026
Date of changes:
Not specified