This page provides popular links to regulations, guidance documents and databases for the following regulatory bodies, ordered as shown:

FDA Medical Device Guidance Documents:

Submission-Related Guidances

510(k) Substantial equivalence – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], July 2014

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k 

510(k) Third Party Review Program, March 2020

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program

513(g) – FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act, December 2019 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic 

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

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM517504.pdf

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2018 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices 

Deciding When to Submit a 510(k) for a Change to an Existing Device: Oct 2017

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device

 

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

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080197.pdf 

Emergency Use Authorization (EUA)

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

IDEs – Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

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 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices 

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

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program 

Other Popular Guidance Docs:

Applying Human Factors and Usability Engineering to Medical Devices, February 2016 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-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

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program

Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, January 2005 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-networked-medical-devices-containing-shelf-ots-software

Design Control Guidance for Medical Device Manufacturers

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers

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 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices

Shelf Life of Medical Devices

https://www.fda.gov/media/72487/download

SteP: Safer Technologies Program (SteP) for Medical Devices, January 2021 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices

European Commission – EU

Regulations and Standards:

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/?uri=CELEX%3A02017R0746-20170505

Harmonized Standards

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

Regulators and NBs:

Competent Authorities for Medical Devices (CAMD)

https://www.camd-europe.eu/

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

https://www.team-nb.org/

MEDDEV:

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/

Medical Device Coordination Group (MDCG):

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 

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf

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

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en.pdf

MDCG 2020-7 – Post-market clinical follow-up (PMCF) Plan Template

A guide for manufacturers and notified bodies 

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_7_guidance_pmcf_plan_template_en.pdf

MDCG 2020-8 – Post-market clinical follow-up (PMCF) Evaluation Report Template: A guide for manufacturers and notified bodies 

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_8_guidance_pmcf_evaluation_report_en.pdf

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

PMDA – Japan

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)

https://www.pmda.go.jp/english/about-pmda/0004.html

National Medical Products Administrations – China

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)

http://english.nmpa.gov.cn/2019-07/25/c_390617.htm

Specific documents listed on Emergo/UL site

https://www.emergobyul.com/resources/regulations-china

ANVISA – Brazil

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

TGA – Australia

Therapeutic Goods Administration

https://www.tga.gov.au/

Regulation Basics

https://www.tga.gov.au/regulation-basics

Information for Industry

https://www.tga.gov.au/industry

Medical Devices and IVDs

https://www.tga.gov.au/medical-devices-ivds

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