United States

When a laboratory may adopt an IVD manufacturer's reference interval, when CLIA requires verification or establishment, and what ISO 15189 adds only for accredited laboratories.

A practical decision guide to UDI placement across medical device packaging levels under FDA, EU MDR, and TGA rules, covering carriers, unique identifiers, and shipper exemptions.

Compare AccessGUDID and FDA's establishment registration and device listing database to choose the correct public record for device identifiers, establishments, and listing status.

Mark whether one US reagent SKU is still an ASR under 21 CFR 864.4020 and 809.30, an RUO or IUO shipment, a general-purpose reagent, or a finished IVD with performance claims.

How to determine whether a US IVD clinical protocol qualifies for 21 CFR 812.2(c)(3) exemption, requires an abbreviated or full IDE, or falls under 21 CFR Part 312 IND rules.

A practical 21 CFR 4.4 worksheet for combination product facilities after QMSR: how to verify eligibility, separate-facility rules, and current ISO 13485 or drug CGMP streamlining clauses.

A practical 21 CFR Part 4 Subpart B worksheet mapping applicant identity, 4.102 baselines and add-ons, statutory reporting clocks, and electronic routing between FAERS, eMDR, and VAERS.

A medical device RA/QA guide to records custody when changing distributors: who keeps complaint and traceability files under US, EU, and Canadian post-market rules.

How medical device RA/QA teams reconcile units, ISO symbols, and released versions across translation cycles before artwork issuance under FDA QMSR 820.45 and EU MDR GSPR 23.

When a supplier change notice omits affected lots, dates, or technical details, device QA must hold unverified product, issue an evidence request, and halt close-out until facts are verified.

A three-asset chain-of-custody crosswalk for medical device loaner exchanges: preserve serial traceability across removal, placement, and return without slot-level record overwrites.

A signed summary is not the deliverable. What protocols, complete reports, raw data, and archive terms medical device manufacturers must contract for premarket evidence and QMSR compliance.

A manufacturer intake worksheet for veterinary analyzer complaints: separate instrument observation, species and matrix, clinic QC evidence, and unsupported causality.

Evaluate whether a configurable EDC study build can reconstruct device models, firmware versions, deficiencies, and endpoint records for FDA and EU MDR trials.

FDA August 2026 container closure systems draft guidance: device-constituent CCS vs packaging, 510(k)/PMA vs NDA, Section V.B.3, and Docket FDA-2026-D-7957.

Operational guide to ISO 20417:2026: FDA Rec# 5-149 complete recognition, the July 1 2029 DoC transition window, ISO 15223-1, 21 CFR 801, and EU MDR GSPR 23.

CMS-1850-P proposed SaMS policy: status indicator O1, Table 61 vs Table 62, CLFS-to-APC rate mismatch, and the August 31, 2026 comment deadline.

FDA DHT clinical investigation guide: investigational device vs remote measurement tool under 21 CFR 812, fit-for-purpose V&V, and August 2026 DDM status.

IEC 62353 in-service electrical safety testing: manufacturer IFU duties, IEC 60601-1 type test differences, CMS S&C 14-07 major repair rules, and NFPA 99.

Manufacturer ISO 80369 conversion guide: route-specific particular parts, FDA recognition transition windows through Dec 17, 2028, and 510(k) change forks.