This page provides popular links to regulations, guidance documents and databases for the following regulatory bodies, ordered as shown:
Affordable Care Act
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/affordable-care-act-aca-6004
CDRH Management Directory by Organization
https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization
Code of Federal Regulations (electronic) – Title 21 CFR – Food and Drugs
https://ecfr.federalregister.gov/current/title-21
Quality System Regulation and Preamble (QSR)
Clinical Laboratory Improvement Amendments (CLIA)
FDA Guidance: In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
FDA Guidance: Design Considerations for Devices Intended for Home Use
https://www.fda.gov/media/84830/download
510(k) Substantial equivalence – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], July 2014
510(k) Third Party Review Program, March 2020
513(g) – FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act, December 2019
Abbreviated 510(k) - How to Prepare an Abbreviated 510(k)
https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-abbreviated-510k
Benefit-Risk – Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2018
Deciding When to Submit a 510(k) for a Change to an Existing Device: Oct 2017
Deciding When to Submit a 510(k) for a Software Change to an Existing Device
https://www.fda.gov/media/99785/download
De Novo - De Novo Classification Process (Evaluation of Automatic Class III Designation) Guidance for Industry and Food and Drug Administration Staff
Emergency Use Authorization (EUA)
IDEs – Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
Medical Device User Fees
https://www.fda.gov/medical-devices/premarket-submissions/medical-device-user-fees
Pre-market Approval (PMA)
https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma
Refuse to Accept Policy for 510(k)s, Sep 2019
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks
Special 510(k) Program, Sep 2019
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program
Software – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005
Traditional 510(k) - How to Prepare a Traditional 510(k)
https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-traditional-510k
Q-Sub – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, January 2021
Acceptance of Clinical Data to Support Medical Device Applications and Submissions – Frequently Asked Questions
Applying Human Factors and Usability Engineering to Medical Devices, February 2016
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
Biocompatibility - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
https://www.fda.gov/media/85865/download
Biocompatibility - Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
https://www.fda.gov/media/142959/download
Breakthrough Devices Program
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, January 2005
Design Control Guidance for Medical Device Manufacturers
PMA Guidance Documents List
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-guidance-documents
Recognized Consensus Standards
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
https://www.fda.gov/media/80265/download
RWE - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, August 2017
Shelf Life of Medical Devices
https://www.fda.gov/media/72487/download
SteP: Safer Technologies Program (SteP) for Medical Devices, January 2021
All medical device databases - FDA listing/links
510(k) Premarket Notification Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Establishment Registration & Device Listing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Guidance Documents search page – CDRH
https://www.fda.gov/regulatory-information/search-fda-guidance-documents
IVD Over the Counter (OTC) Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm
IVD Diagnostic Product Database
https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm
CLIA Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
MAUDE Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
Premarket Approval (PMA) Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
Product Code Classification Database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm
Recent Final Medical Device Guidance Documents
Warning Letters database.
EU MDR Consolidated Text: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05
EU IVDR Consolidated Text: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746
Harmonized Standards
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
Unique Device Identification (UDI) Helpdesk
Competent Authorities for Medical Devices (CAMD)
European Commission – Medical Devices Sector: Overview
https://ec.europa.eu/health/md_sector/overview_en
Global Harmonization Task Force Archive (GHTF)
http://www.imdrf.org/ghtf/ghtf-archived-docs.asp
International Medical Device Regulators Form (IMDRF)
http://www.imdrf.org/documents/documents.asp
Team NB – The European Association for Medical Devices of Notified Bodies
MEDDEV – Europa list of Guidance MEDDEV’s with links
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance_meddevs.pdf
MEDDEV 2.7/1 Rev 4 – Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42 and 90/385
https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/
MDCG endorsed documents and other guidance applying MDR and IVDR – list with links
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
MDCG 2019 – Summary of safety and clinical performance: A guide for manufacturers and notified bodies
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2019_9_sscp_en.pdf
MDCG 2020-5 – Clinical Evaluation – Equivalence: A guide for manufacturers and notified bodies
MDCG 2020-6 – Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC: A guide for manufacturers and notified bodies
MDCG 2020-7 – Post-market clinical follow-up (PMCF) Plan Template
A guide for manufacturers and notified bodies
MDCG 2020-8 – Post-market clinical follow-up (PMCF) Evaluation Report Template: A guide for manufacturers and notified bodies
MDCG 2020-13 – Clinical evaluation assessment report template
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-13-cea-report-template_en.pdf
MDCG 2021-6 – Regulation (EU) 2017/745: Questions & Answers regarding clinical investigation
https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-6_en.pdf
Medicines and Healthcare Products Regulatory Agency
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Guidance and regulation
Medical devices regulation and safety: detailed information
https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety
New guidance and information for industry from the MHRA on BREXIT
https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra
Health Canada
https://www.canada.ca/en/health-canada.html
Food and Drugs Act (R.S.C., 1985, c. F-27)
https://laws-lois.justice.gc.ca/eng/acts/F-27/
Health Canada Guidance Document –Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)
Health Canada Guidance Document – Labelling of In Vitro Diagnostic Devices
Medical Devices – General Information
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
Medical Devices Active Licences Search
Medical Device Application Forms
Medical Device Application Guidance Document - How to Complete the Application for a New Medical Device Licence
Post-Market Summary Reports – Guidance on summary reports and issue-related analyses for medical devices: Overview
Pharmaceuticals and Medical Devices Agency (PMDA)
https://www.pmda.go.jp/english/
Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD) Act No. 145 of August 10, 1960
http://www.japaneselawtranslation.go.jp/law/detail/?id=3213&vm=04&re=02
Quality Management System Requirements Stipulated in MHLW Ministerial Ordinance No. 169
https://www.pmda.go.jp/english/review-services/regulatory-info/0004.html
Frequently Asked Questions (In English)
National Medical Products Administration
http://english.nmpa.gov.cn/index.html
Medical Devices
http://english.nmpa.gov.cn/medicaldevices.html
Provisions for Medical Device Registration (Decree No. 4 of China Food and Drug Administration)
Brazilian Health Regulatory Agency (Anvisa)
https://www.gov.br/anvisa/pt-br/english
Medical devices
https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices
Therapeutic Goods Administration
Regulation Basics
https://www.tga.gov.au/regulation-basics
Information for Industry
https://www.tga.gov.au/industry
Medical Devices and IVDs
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