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The new EU Securitisation Framework
  • Reed Smith LLP
  • European Union
  • December 10 2018

From 1 January 2019, the EU Securitisation Regulation will replace the current sector-specific approach to regulating securitisations with a set of


FDA De Novo Device Classification Process & Preemption
  • Reed Smith LLP
  • USA
  • December 10 2018

The FDA has recently released a proposed rule “to establish requirements for the medical device De Novo classification process” provided in 21 U.S.C


CMS Tweaks HCPCS Coding Process to Promote Transparency, Ease Device Market Volume Requirement
  • Reed Smith LLP
  • USA
  • December 7 2018

Responding to longstanding industry criticisms, the Centers for Medicare & Medicaid Services (CMS) has announced a number of changes to the Healthcare


Does GDPR require non-EU companies to nominate EU representatives? EDPB issues guidance
  • Reed Smith LLP
  • European Union
  • December 7 2018

On 16 November 2018, the European Data Protection Board (EDPB) adopted draft guidelines on the territorial scope of the General Data Protection


FDA Announces Its Plan for Encouraging Reliance on Newer Predicate Devices and Medical Device Performance Criteria
  • Reed Smith LLP
  • USA
  • December 7 2018

On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway” by encouraging


“Alter Ego” Allegations Aren’t Enough For Personal Jurisdiction
  • Reed Smith LLP
  • USA
  • December 7 2018

A federal court in Utah ruled the other day that it had no personal jurisdiction over a corporate parent, even though the plaintiffs alleged that the


FTC eyes contact lens trademark settlement agreements
  • Reed Smith LLP
  • USA
  • December 6 2018

Over a spirited dissent, and in a 3-1 decision issued on November 14, the Federal Trade Commission (FTC) Commissioners held that 1-800 Contacts


The PRC Ministry of Public Security (MPS) is seeking public comments on the draft of new personal data protection rules
  • Reed Smith LLP
  • China
  • December 6 2018

On November 30, 2018, the Network Security Protection Bureau of the PRC Ministry of Public Security (MPS) published the draft “Guideline for Internet


New Medicare Supervision Rules Applicable to both Physician Offices and Hospital Outpatient Departments
  • Reed Smith LLP
  • USA
  • December 6 2018

In a transmittal issued last week, the Centers for Medicare & Medicaid Services (CMS) extended newly-revised supervision rules for certain diagnostic


A Couple of MDL Ideas from the Recent ACI DrugDevice Conference
  • Reed Smith LLP
  • USA
  • December 6 2018

Late last month Bexis attended the annual ACI Drug and Medical Device Conference in New York. In between helping to lead the discussion in the