Regulatory Affairs

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August 4, 2020
FDA Issues Guidance on Multiple-Function Devices
If the device’s medical effectiveness could be compromised by its non-medical functions, the manufacturer should consider the possible adverse effects on the device’s medical performance, the agency says.
August 3, 2020
FDA Exempts Five Types of Class II Devices From 510(k) Requirements
The FDA is exempting five types of Class II devices from premarket notification 510(k) requirements, subject to certain limitations.
August 3, 2020
MHRA Warns of Phony Compliance Certificates
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certificates are being issued by certification bodies titled “certificates or compliance,” or “attestation of compliance,” that have no legal standing under the UK’s medical device regulations.

August 3, 2020
FDA Issues Guidance on Multiple-Function Devices
August 3, 2020
UK Government Calls for Urgent Reforms at MHRA Due to Safety Failings
July 27, 2020
EMA Committee Recommends Dapivirine Vaginal Ring
July 24, 2020
Government Review Proposes Reforms at UK’s MHRA
July 24, 2020
Foundation Calls for $75 Billion to Expand COVID-19 Testing

July 23, 2020
Lawmakers Call for Answers on COVID-19 Antibody Test Scams
July 22, 2020
FDA Delays New UDI Requirements Until September 2022
July 22, 2020
MedTech Europe Calls for Allowing Virtual Audits by Notified Bodies
July 20, 2020
FDA Updates Guidance on 510(k)s for Atherectomy Devices
July 20, 2020
FDA’s Regulatory Agenda Features Final Rule on De Novo Classification