• Brazil Drops International GMP Inspection Proposal

    The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites. Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution. Moreover, elements of the earli...
  • UK Opens Consultation on Proposed EU Device Legislation

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) opened a public consultation on 12 November 2012 on the European Commission's proposals for three new medical device regulations set to replace existing EU directives. The proposals-two on medical devices and one on in vitro diagnostic devices (IVDs)-are still in draft form, and MHRA said it was urging industry and the public to comment on them before they become final. The proposals are a direct resul...
  • European Commission to Revise IVD Regulatory Framework

    The European Commission (EC) plans to adopt a new proposal to revise the regulatory framework for in vitro diagnostic (IVD) medical devices in Europe during the week of 27 September, its commissioner has announced.  The proposal is intended to facilitate the development of personalized medicine by enhancing the safety and performance requirements applicable to the IVDs that will serve as companion devices to new drugs.  According to European Commissioner for He...
  • MHRA Releases IVD Guidance for Notified Bodies

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guidance for notified bodies pertaining to the regulation of in vitro diagnostic (IVD) products used in home healthcare settings for self-testing. Assuring the safe use of these products is a challenge, the agency notes, as there is unlikely to be a healthcare professional present to guide the patient in the proper use of the device or the correct interpretation of its results. "It i...
  • Brazil: New IVD Guidance Aims to Assist Small Businesses

    A new guidance manual for the in vitro diagnostic (IVD) business sector is intended to assist companies in how to obtain the right to market their products in Brazil.  The Manual was developed by Brazil's national regulatory agency, Anvisa, in collaboration with the Brazilian Agency for Industrial Development (ABDI) and the Agency for Support to Entrepreneurship and Small Business (Sebrae).  The collaborative effort is especially intended to assist local com...
  • GHTF Changes Definitions of 'Medical Device' and 'IVD'

    The Global Harmonization Task Force (GHTF), an international harmonization body whose duties are soon to be subsumed by the International Medical Devices Regulators' Forum (IMDRF), has released a final guidance altering how medical devices are defined. The GHTF final document, SG1-N71:2012 - Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device' , makes four changes to existing guidance by modifying the existing definition of 'medica...
  • CDRH: New Pilot Seeks to Dramatically Speed up 510(k) Reviews Based on High Regulatory Quality

    A new pilot program announced by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) aims to dramatically speed up 510(k) medical device reviews for manufacturers of certain in vitro diagnostic (ICD) and radiology products. The announcement, made 17 April by Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), claims the project, dubbed the "Triage" pilot, should get submission d...
  • FDA Releases Most Recent Accounts of MDUFA Negotiations, Unveils Upcoming Regulations

    The US Food and Drug Administration (FDA) released a cache of meeting minutes from the February negotiations over the Medical Device User Fee Act (MDUFA) reauthorization language. The minutes give a timely look in to the negotiations over what many deem must-pass legislation. The minutes also give insight into future FDA medical device regulation. Minutes from the 17 February negotiations indicate that FDA is committed to exempting " additional low risk medical devi...
  • GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs

    The Global Harmonization Task Force released a new proposed document for their Study Group 5 (SG5) category called " Clinical Performance Studies for In Vitro Diagnostic Medical Devices ." The document provides guidance for IVD medical devices, including the selection of clinical performance study design and the considerations to be made when undertaking those studies. The document notes that "As IVD medical devices are used on specimens taken from the human body, th...