Medical Device Convenience Kits

Unique Device Identification: Convenience Kits | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-convenience-kits

This guidance describes FDA’s interpretation of the definition of “convenience kit” at 21 CFR 801.3 and as used in 21 CFR 801.30 (a) (11). This guidance does not apply to in …

Convenience Kits Interim Regulatory Guidance | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/convenience-kits-interim-regulatory-guidance

UDI Update: FDA finalizes guidance for convenience kits

https://www.hpnonline.com/regulatory/article/21077970/udi-update-fda-finalizes-guidance-for-convenience-kits

FDA offers five examples of the types of convenience kits that will require UDI compliance. According to FDA’s 21 CFR 801.3 a convenience kit is “two or more …

A Closer Look at the FDA’s UDI Guidance: Which …

https://www.reedtech.com/knowledge-center/a-closer-look-at-fdas-udi-guidance-for-convenience-kits/

Convenience kits – which FDA defines as “two or more different medical devices packaged together for the convenience of the user” (21 CFR 801.3) – represent …

Sterilized Convenience Kits for Clinical and Surgical Use …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterilized-convenience-kits-clinical-and-surgical-use

The Center for Devices and Radiological Health (CDRH) continues to have concerns about finished device components that are assembled into clinical or surgical convenience kits …

FDA Clarifies its Definition of “Convenience Kit” - ProPharma Group

https://www.propharmagroup.com/thought-leadership/fda-udi-exemption-convenience-kit

On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s …

Systems and Procedure Packs: Regulatory …

https://www.johner-institute.com/articles/regulatory-affairs/and-more/systems-procedure-packs/

The devices packaged together in a convenience kit are not necessarily (all) used for a single medical purpose. Examples of convenience kits are first aid kits or sets of …

Labeling and UDI requirements for medical device kits

https://elsmar.com/elsmarqualityforum/threads/labeling-and-udi-requirements-for-medical-device-kits.72157/

Feb 8, 2018. #1. Hello, I’m trying to understand the UDI and labeling procedures when building medical device kits and the requirements necessary. I’ve been …

FDA Clarifies Labeling Identifier Rules for Convenience Kits

https://www.fdanews.com/articles/191096-fda-clarifies-labeling-identifier-rules-for-convenience-kits

The FDA considers first aid and other “convenience” kits a single device for regulatory purposes, the agency said in final guidance. The agency is hoping to simplify …