Medical Devices Standards Database

Medical Device Databases | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Apr 6, 2022

Recognized Consensus Standards - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Standards and Conformity Assessment Program | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/standards-and-conformity-assessment-program

As the FDA determines that new or revised standards are appropriate for meeting requirements under the FD&C Act for medical devices, we will update the …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. ... Search Medical Device Databases. 510(k) Premarket …

Data Standards and Terminology Standards for …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/data-standards-and-terminology-standards-information-submitted-cdrh

ISO - ISO 13485 — Medical devices

https://www.iso.org/iso-13485-medical-devices.html

A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or …

Ultimate List of ISO Standards for Medical Devices

https://www.greenlight.guru/blog/iso-standards

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet …

Product Code Classification Database | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code …

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related …

Standards for Medical Devices in Japan - Pmda

https://www.std.pmda.go.jp/stdDB/index_en.html

What's New. [2023/01/31] ＜MD＞8 Japanese Medical Device Nomenclatures (JMDN) are established. [2023/01/06] ＜MD＞One Japanese Medical …