Federal Register notice: FDA releases its FDA Information Technology Strategy, which is open for comments until 10/30.
FDA grants InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as an adjunctive thera...
Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software.
FDA warns Miramar, FL-based Kimera Labs about illegally manufacturing and distributing unapproved exosome products that have CGMP deviations.
FDA publishes a draft CDRH strategic plan for medical device international harmonization.
Three Ropes & Gray attorneys analyze three FDA draft guidances intended to modernize the 510(k) program, saying they are likely to be precursors to fu...
Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and W...
FDA says it is converting its medical device Accreditation Scheme for Conformity Assessment from a pilot to a permanent program.
