Equivalency Determinations

News & Analysis as of

D.C. Circuit Rejects FDA’s Claim of Inherent Authority to Reclassify a Device by Rescinding a 510(k) Substantial Equivalence Order

On September 26, 2014, the D.C. Circuit issued an opinion holding that the Food and Drug Administration (“FDA”) failed to follow the appropriate statutory procedure for reclassifying a device when the Agency relied on its...more

European Commission Adopts First Equivalence Decisions for Non-EU CCPs

On October 30, the European Commission (EC) adopted its first equivalence decision for the regulatory regimes of central counterparties (CCPs) located in four jurisdictions: Australia, Hong Kong, Japan and Singapore. ...more

Governance & Securities Law Focus - October 2013

In this issue: - ASIAN DEVELOPMENTS - HKEx publishes Amended Listing Rules to Complement the New IPO Sponsor Regime - US DEVELOPMENTS - SEC Developments - Noteworthy US Securities Law...more

ESMA Advice on Third-Country Equivalence Under EMIR, II

On 3 September, ESMA published its technical advice to the European Commission on the equivalence of the US and Japanese derivatives frameworks to the EU rules. On 2 October, ESMA supplemented its technical advice with...more

ESMA Publishes Advice to the Commission on Equivalence of Certain Non-EU Countries’ Regulatory Regimes Under EMIR

On September 3, the European Securities and Markets Authority (ESMA) published its advice to the European Commission (the Commission) on the equivalence of the regulatory regimes of Australia, Hong Kong, Japan, Singapore,...more

ESMA Advice on Third-Country Equivalence Under EMIR

Clarity to market participants on the equivalence of derivatives rules to European requirements has been much anticipated. On 3 September, ESMA published its technical advice to the European Commission on the equivalence of...more

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