requirements Archives - In Compliance Magazine

FDA Issues Updated Guidance on Medical Device UDI Requirements

The U.S. Food and Drug Administration (FDA) has released an updated Guidance on the unique device identification (UDI) requirements for medical devices, easing its requirements for certain types of low-risk dev... Read More...

FCC Proposes New Data Breach Reporting Requirements

The U.S. Federal Communications Commission (FCC) is preparing to strengthen rules applicable to the reporting of breaches of certain customer information collected and maintained by telecommunications providers... Read More...

FCC Considers Revising/Eliminating WWII-Era Antenna Site Requirements

The U.S. Federal Communications Commission (FCC) is exploring eliminating or revising certain decades-old rules applicable to television and FM radio antenna sites. In a Notice of Proposed Rulemaking issued ... Read More...

FDA Issues Guidance on Premarket Submission Info on Performance Testing

The U.S. Food and Drug Administration (FDA) has issued a new guidance intended to help manufacturers of medical devices better understand the agency’s requirements regarding the submission of certain performanc... Read More...

FCC Reiterates Requirements for Two-Way VHF/UHF Radios in U.S.

The U.S. Federal Communications Commission (FCC) is reminding retailers that two-way VHF/UHF radios are not exempt from FCC regulations and must be authorized by the Commission prior to their being imported, ad... Read More...

Commission Amends Short-Range Radio Spectrum Harmonization Requirements

As part of its effort to keep pace with rapid changes in the technology and use of short-range communications, the Commission of the European Union (EU) has issued an update of its harmonized technical conditio... Read More...

FDA Exempts 70 Plus Class I Devices from 510(k) Premarket Notification

The U.S. Food and Drug Administration (FDA) has identified an extensive list of Class 1 medical devices that it says will no longer be subject to pre-market notification requirements. In an agency Notice pub... Read More...

New Clinical Evaluation Requirements for Medical Devices

ANVISA, Brazil’s medical device market regulator, has announced new clinical evaluation requirements that are applicable to all novel medical devices, as well as those high-risk medical devices currently subjec... Read More...

The Capacitive Discharge Test

This article will define the test requirements, and discuss the methods used to obtain results. Limitations of the equipment used will also be discussed, so that lab personnel can be made aware and do their best to minimize tolerance errors.

FDA Issues New UDI Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on the form and content of unique device identifiers (UDIs) required by the FDA for approval of medical devices to be marketed or sold... Read More...

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