• Regulatory NewsRegulatory News

    FDA pushes back deadline for removal of legacy identifiers to 2023

    After receiving pushback from industry, the US Food and Drug Administration (FDA) on Thursday said it will give medical device makers two more years to remove legacy identification numbers from their product labels and packages.   Under FDA’s 2013 unique device identification (UDI) final rule, medical device labels and packages are required to bear a UDI according to the schedule set in the final rule, with some exceptions and alternatives for certain devices. The UDI ...
  • Regulatory NewsRegulatory News

    FDA Pushes Back Enforcement of UDI Rule Provisions

    The US Food and Drug Administration (FDA) on Monday finalized guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time. The shift in enforcement comes as FDA says it wants to make sure it gives companies enough time to make changes to the medical device reimbursement, supply chain and procurement systems and proces...
  • Regulatory NewsRegulatory News

    FDA Extends Deadline for Some UDI Requirements for Medical Devices

    The US Food and Drug Administration (FDA) is giving manufacturers more time to remove drug codes from certain medical device labels in compliance with unique device identifier (UDI) requirements to avoid disrupting patient access to devices. Specifically, the agency says it will enforce a statutory prohibition on National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers for device labels and packaging for certain devices. In 2013, FDA issued its fin...
  • Regulatory NewsRegulatory News

    The Top 15 Medical Device Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 972 Form 483s—forms indicating areas of noncompliance at a facility—to medical device companies in fiscal year 2014. ...
  • Regulatory NewsRegulatory News

    India Proposes eSubmission Process for Clinical Trials

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) has published a proposal to create an information technology (IT) system that would permit the online submission of information on clinical trials by sponsors, clinical research organizations (CROs), investigators, e...
  • FDA Will Continue to Allow Unapproved Drugs to Receive National Drug Code Numbers

    The US Food and Drug Administration (FDA) will continue to grant national drug code (NDC) numbers to pharmaceutical and other drug products not explicitly approved by FDA for a given indication after rejecting a Citizen Petition from Susan Alpert, RAC. Background NDCs were created in 1969 as a response to the difficulties of processing claims in the absence of a standardized product identification system for drug products. The NDCs were intended to provide "an identific...
  • FDA Releases Adverse Event Guidance for Small Businesses

    The US Food and Drug Administration (FDA) wants to help small businesses comply with regulations pertaining to adverse event reporting. In 2008, the agency released a new regulation directing all companies to include a hotline number for FDA's adverse event reporting service, which collects information about safety issues. The number must coincide with an explanation of what the number is, and that it is not intended for dispensing medical advice. In its 14 June guidanc...
  • FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products

    The US Food and Drug Administration (FDA) announced in a Federal Register posting on 18 May it has not yet come to a conclusion regarding a Citizen Petition request to stop the issuance of national drug codes (NDCs) for products lacking either a New Drug Application (NDA)or Abbreviated New Drug Application (ANDA) number. The Citizen Petition was filed in December 2011 by Dr. S. Albert Edwards, RAC, who requested FDA phase out the use of NDCs over a three-year period. C...