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Results:1-10 of 17

FDA Regulatory and Compliance Monthly Recap November 2018
  • Loeb & Loeb LLP
  • USA
  • November 8 2018

Medical device enforcement report points to heightened oversight, uptick in foreign inspections The report signals an uptick in device inspections


FDA finalizes clarifying process for classifying combination products as drugs, biologics or medical devices
  • Loeb & Loeb LLP
  • USA
  • October 30 2017

The FDA’s finalized guidance places a particular focus on cases in which a combination product may be classified as a drug or device. The document


FDA publishes draft guidance on statistical approaches to assessing analytical similarity of biosimilars
  • Loeb & Loeb LLP
  • USA
  • October 30 2017

The FDA issued a draft guidance document to assist with the marketing application submission for biosimilar products. As part of the application


FDA draft guidance offers recommendations on how to ensure proper dissemination by manufacturers of patient-specific information derived from medical devices
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The document clarifies that medical device manufacturers may share patient-specific data from a medical device with the patient using that specific


FDA issues draft guidance to update policy on categorizing investigational device exemption devices to assist CMS coverage decisions
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The draft guidance will amend the FDA's 20-year-old policy for categorizing devices as experimental or nonexperimental based on initial questions of


FDA releases finalized guidance to clarify how to extrapolate clinical data to support pediatric medical devices labeling
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The document is a revision of draft guidance initially published in May 2015. It explains the circumstances in which it may be appropriate to


FDA issues draft guidance detailing benefit-risk approach when considering medical device availability, compliance and enforcement decisions
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The draft guidance aims to shed light on appropriate responses to nonconforming product or regulatory compliance issues related to diagnostic and


FDA issues final rule allowing for inclusion of stand-alone symbols on medical device and in vitro diagnostic labels
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The final rule, in addition to allowing the optional use of symbols not accompanied by explanatory text ("stand-alone symbols"), permits the use of


FDA issues guidance on leveraging adult clinical data to support marketing approval and labeling of pediatric devices
  • Loeb & Loeb LLP
  • USA
  • May 31 2015

The regulator is looking to remedy a lack of available scientific evidence to support pediatric device indications in PMA applications and HDEs by


CDRH provides guidance on adaptive designs for clinical trials for medical devices in a bid to speed up decision-making
  • Loeb & Loeb LLP
  • USA
  • May 31 2015

Keeping in line with its risk-based approach to regulation, the agency issued guidance on planning and implementing adaptive designs as