We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 501

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns
  • Hogan Lovells
  • USA
  • January 17 2018

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations


FDA Announces Enforcement Discretion for Certain FSMA Provisions
  • Hogan Lovells
  • USA
  • January 8 2018

On January 4, 2018, the Food and Drug Administration (FDA) announced through Guidance that it does not intend to enforce particular provisions of the


The Crackdown Continues: FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns
  • Hogan Lovells
  • USA
  • January 5 2018

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcellan adipose tissue derived stem cell


FDA finalizes 3D printing guidance
  • Hogan Lovells
  • USA
  • December 20 2017

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its "leapfrog guidance" entitled, "Technical


Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents
  • Hogan Lovells
  • USA
  • December 15 2017

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework


New Legislation Increases Access to Medical Products for Military Applications
  • Hogan Lovells
  • USA
  • December 12 2017

Today, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development


FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies
  • Hogan Lovells
  • USA
  • November 22 2017

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance


FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement
  • Hogan Lovells
  • USA
  • November 17 2017

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine


FDA Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist
  • Hogan Lovells
  • USA
  • November 17 2017

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo


FDA issues long-awaited final guidance on when a device modification requires a new 510(k)
  • Hogan Lovells
  • USA
  • November 2 2017

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission