Design Control Guidance for Medical Device Manufacturers

U.S. Food and Drug Administration. (1997). Design Control Guidance for Medical Device Manufacturers.

Type

Report

Intellectual base

Grey literature

Year

1997

Link

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

Cited from

engineering_design

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Primes

• Failure Mode and Effects Analysis (FMEA)

  • This sourceDefines design controls and integrates risk management (with FMEA as the primary risk-analysis tool, supplemented by FTA) into the device design process. Tier C: listed in References, not cited at any FACT marker or inline in the body. Existence-verified and linked. CITATION-FIX: the prime dates it 2016; the canonical guidance is 1997.

Verification

This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.

Registry ID ref:ff817cd110ba · see in the full table