Resources
Official regulatory sources, in one place.
The databases, regulations and guidance we use every day — linked to the official sites. Reglo is not affiliated with these organizations.
United States — FDA
Device Advice
FDA’s main guide to device laws, regulations, getting to market and postmarket duties.
FDAEnglish siteProduct Classification database
Find your device’s product code, regulation number, class and submission type.
FDAEnglish site510(k) database
Search 510(k) clearances by product code, applicant or decision date — useful for finding predicates.
FDAEnglish siteDe Novo database
De Novo decisions for novel low-to-moderate risk devices.
FDAEnglish sitePMA database
Premarket approvals and supplements for Class III devices.
FDAEnglish siteQ-Submission program guidance
How to request FDA feedback or a meeting (Pre-Sub) before a 510(k), De Novo, PMA or IDE.
FDAEnglish siteeSTAR program
eSTAR templates and instructions; required for 510(k) and De Novo submissions.
FDAEnglish siteQuality Management System Regulation (QMSR)
21 CFR Part 820, in effect since 2 February 2026; incorporates ISO 13485:2016 by reference.
FDAEnglish siteQMSR frequently asked questions
FDA answers on inspections, records in scope and how QMSR compares with MDSAP.
FDAEnglish siteEstablishment registration & device listing
Annual registration and listing requirements (21 CFR 807), fees and help.
FDAEnglish siteMDUFA user fees
Current 510(k), De Novo, PMA and registration fees, and small-business discounts.
FDAEnglish siteRecognized consensus standards
Standards FDA recognizes for use in premarket submissions via a Declaration of Conformity.
NIH / FDAEnglish siteAccessGUDID (UDI)
Public database of device identifiers submitted to FDA’s GUDID.
FDAEnglish siteMAUDE adverse event database
Medical device reports from manufacturers, importers, user facilities and voluntary reporters.
European Union — MDR / IVDR
Regulation (EU) 2017/745 — MDR
Official text of the Medical Device Regulation, in all EU languages.
EUR-LexMultilingualRegulation (EU) 2017/746 — IVDR
Official text of the In Vitro Diagnostic Medical Devices Regulation.
European CommissionEnglish siteMDCG guidance documents
Guidance on classification, clinical evaluation, PMS, UDI, software and more.
European CommissionEnglish siteNANDO — notified bodies
Search notified bodies designated under MDR and IVDR.
European CommissionEnglish siteEUDAMED
EU database for actors, UDI/devices, notified bodies and certificates.
China — NMPA
International & standards
International Medical Device Regulators Forum
Harmonized guidance from device regulators worldwide.
FDAEnglish siteMDSAP
One QMS audit accepted by several participating regulators.
ISOEnglish siteISO 13485:2016
Quality management system requirements for medical device organizations.
ISOEnglish siteISO 14971:2019
Application of risk management to medical devices.
Links last checked: November 6, 2026
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