About MedDevRegs
MedDevRegs is a regulatory guidance resource for medical device manufacturers, regulatory affairs professionals, and quality engineers. The site covers FDA premarket submission pathways, EU MDR conformity assessment, quality system requirements, and software-specific regulatory frameworks with references to applicable statutes, regulations, and international standards.
Purpose
Bringing a medical device to market requires navigating regulatory pathways that differ by jurisdiction, device classification, and intended use. This site organizes the key regulatory requirements into structured guides, submission checklists, and process templates. Every requirement is cited with its regulatory source -- CFR section, EU regulation article, or international standard clause -- so that readers can verify the source material independently.
What This Site Covers
- Regulatory Pathways -- FDA 510(k) clearance (21 CFR 807 Subpart E), Premarket Approval for Class III devices (21 CFR 814), and De Novo classification for novel low-to-moderate risk devices (21 CFR 860.260)
- Compliance Guides -- EU Medical Device Regulation 2017/745 (classification rules, conformity assessment, EUDAMED), Quality System Regulation (21 CFR 820), and Software as Medical Device (IEC 62304, IMDRF framework)
- Templates -- 510(k) submission checklist with all required sections per FDA guidance, and ISO 14971 risk management process template
Intended Audience
This resource is designed for regulatory affairs specialists, quality assurance engineers, product development teams, clinical affairs professionals, and consultants involved in the design, manufacture, and commercialization of medical devices. It serves both organizations entering the medical device market for the first time and established manufacturers expanding into new regulatory jurisdictions.
Regulatory Sources
Content on this site is based on the following regulatory and standards sources:
- Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended
- 21 CFR Part 807 -- Establishment Registration and Device Listing (Subpart E: Premarket Notification)
- 21 CFR Part 814 -- Premarket Approval of Medical Devices
- 21 CFR Part 820 -- Quality System Regulation
- 21 CFR Part 860 -- Medical Device Classification Procedures
- Regulation (EU) 2017/745 -- Medical Device Regulation (MDR)
- ISO 14971:2019 -- Medical devices: Application of risk management to medical devices
- IEC 62304:2006+AMD1:2015 -- Medical device software: Software life cycle processes
- IMDRF SaMD Working Group Documents (N10, N12, N23, N41)
- FDA Guidance: Content of Premarket Submissions for Device Software Functions
- FDA Guidance: Cybersecurity in Medical Devices
Disclaimer
This site provides general information about medical device regulations and compliance requirements. It does not constitute legal or regulatory advice, and no professional relationship is created by use of this site. Regulations and guidance documents are subject to change. FDA enforcement priorities and interpretations evolve through warning letters, consent decrees, and updated guidance documents. EU MDR requirements may be further clarified through implementing acts and MDCG guidance. Consult qualified regulatory affairs professionals and legal counsel for guidance specific to your device and intended markets.