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  6. OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality
  1. CDRH Offices

OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality

Who We Are

The Office of Health Technology 5 within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for the total lifecycle (TPLC) review of neurological and physical medicine devices.

What We Do

For neurological and physical medicine medical devices, we:

  • Implement a TPLC model for the office's medical device product area.  The TPLC model includes implementation of premarket review programs (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.), compliance and quality programs (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.), and surveillance programs (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.
  • Serve as the primary source for scientific and medical expertise with regard to safety and effectiveness of medical devices throughout the total product lifecycle.
  • Provide initial support for questions related to regulatory programs in response to specific requests from medical device and health technology industries, trade associations, other Federal agencies, other countries, State agencies, and the general public.
  • Work closely with other offices on classification and reclassification activities, and the development of guidance documents.
  • Advise, coordinate, and provide consultation to the OPEQ Director and other Agency officials on Office programs and policies concerning premarket review, compliance and quality, and postmarket surveillance.
  • Participate in the development of national and international consensus standards, and voluntary guidelines through interaction with national and international standards committees.

Office Organization

Who We Are

The Division of Health Technology 5A is responsible for the total lifecycle (TPLC) review of neurological, neurointerventional and neurodiagnostics devices.

What We Do

For neurological, neurointerventional and neurodiagnostics devices, we:

  • Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.).
  • Coordinate, carry out and make postmarket compliance and quality determinations (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.).
  • Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.).
  • Participate in development and interpretation of post market regulations and policies.
  • Coordinate actions on classification.
  • Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.

Who We Are

The Division of Health Technology 5A is responsible for the total lifecycle (TPLC) review of neuromodulation and physical medicine devices.

What We Do

For neuromodulation and physical medicine medical devices, we:

  • Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.).
  • Coordinate, carry out and make postmarket compliance and quality determinations (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.).
  • Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.).
  • Participate in development and interpretation of post market regulations and policies.
  • Coordinate actions on classification.
  • Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.

Contact Us

For specific phone numbers and email addresses for each office, see the CDRH Management Directory by Organization.

For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.



 
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