CaptureTransformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

Changes to modernize  510(k) clearance pathway, which accounts for majority of FDA reviews

  • To keep pace with increasing complexity of rapidly evolving technology
  • To efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety

Reliance on more modern predicate devices or objective performance criteria

  • Predicates that are <10 years old
  • Public website on cleared devices with substantial equivalence to older predicates
  • Rename new approach the “Safety and Performance Based Pathway
    • Focus on advancing improved safety and performance of new products
    • Ensure novel device meets modern performance-based criteria that reflect current technological principles

Report on Strengthening the 510(k) program

  • Increased premarket expectations
  • Implemented a Refuse-To-Accept policy to improve the quality of submissions
  • Improved consistency and thoroughness of review
  • Eliminated use of 510(k) for Class III devices
  • Eliminated use of > 1000 510(k)s as legal predicates

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CaptureFDA’s increased inspections of medical device manufacturers and targeted risk-based approach leads to improved compliance

FDA has increased its oversight through additional device inspections since 2007

  • Increase in annual number of device inspections by 46%
  • Increased annual inspections of foreign firms by 243%
  • Established Medical Device Single Audit Program to allow for a single audit on behalf of multiple countriesf  urther increased the FDA’s oversight of foreign manufacturing facilities
  • Targeted risk-based approach to addressing concerns with specific devices e.g. infusion pumps, automated external defibrillators
  • Increased compliance actions and voluntary recalls leading to better compliance, improved device quality, reduction in reported injuries and deaths
  • Identifying reporting deficiencies during inspections leading to increase in voluntary recalls and adverse event reporting
  • Case for Quality initiative that includes a voluntary quality maturity appraisal pilot launched this year.

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 Monitoring Social Media to Better Understand Drug Use Trends

Proactive pharmacovigilance using nontraditional monitoring process is to identify and analyze content found in conversations occurring online and on social media sites

  • Inform prescription drug use or abuse – explore in greater depth through more detailed and rigorous primary data collection efforts
  • Use data gleaned from social media monitoring –  inform communications activities, identify potential new trends
  • Methods to monitor social media platforms – Twitter, Facebook, Instagram, also forums, blogs, discussion groups, news sites, and other nontraditional sites
  • Recognize benefits and limitations
  • EXAMPLE- Gabapentinoids use increase – focus on misuse and abuse based on online conversations

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Prescription Drug-Use-Related Software

“Prescription drug-use-related software” refers to:

  • Software (e.g. App) disseminated by or on behalf of a drug sponsor
  • Accompanies one or more of the sponsor’s prescription drugs, including biological drug products

Proposed framework takes risk-based approach to prescription drug use-related software

  • Anticipated that output of such software will not require FDA review prior to dissemination
  • Dependent on whether software is a ‘device’ per CDRH assessment

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New Efforts to Address Drug Shortages

Ensuring that necessary drug is available to patient involves a lot of stakeholders working together at key stages of the development, manufacturing, marketing, and distribution 

  • Immediate need: External factors (bioterror attacks, natural disasters)
  • Long-term need : Interagency Drug Shortages Task Force to investigate root causes  and take new approach to advance long-term solutions
  • Public engagement: Upcoming public meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions

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Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

Allow responsible IRB to approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent or waives requirement to obtain informed consent 

  • Clinical investigation involves no more than minimal risk to subjects
  • Waiver or alteration of informed consent will not adversely affect rights and welfare of subjects
  • Clinical investigation could not practicably be carried out without waiver or alteration of informed consent
  • Whenever appropriate, subjects will be provided with additional pertinent information after participation

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Image credits: FDA

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