Sensors NSI: Sensor Development



Regulatory Guidance

FDA Office of In Vitro Diagnostics and Radiological Health

  • FDA Pre-Submission Guidance Document: The Pre-Submission program is intended to allow sponsors the opportunity to obtain targeted FDA feedback in response to specific questions related to product development, including planned nonclinical evaluations, proposed clinical study protocols, or data requirements prior to making a submission to the agency. The Pre-Sub is not a required submission and is entirely voluntary on the part of the sponsor.
  • FDA In Vitro Device (IVD) Regulatory Assistance

Links for Medical Device Developers from FDA Center for Devices and Radiological Health (CDRH):

FDA Nanotechnology Main Page

Clinical Laboratory Standards Institute (CLSI):[1] CLSI is a not-for-profit membership organization that develops clinical laboratory testing standards based on input from and consensus among industry, government, and health care professionals. FDA recognizes CLSI standards as appropriate for use in submissions to FDA.

Control of Nanoscale Materials under the Toxic Substances Control Act (TSCA): Many nanoscale materials are regarded as "chemical substances" under TSCA. To ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, EPA is pursuing a comprehensive regulatory approach under TSCA. 

The CPSC Small Business Ombudsman (SBO) provides small businesses with guidance to ensure that consumer products are in compliance with the applicable Federal consumer product safety laws. The SBO serves as a liaison between small businesses and agency staff with problems and questions regarding compliance with agency rules and facilitates training and outreach events for small businesses.

Other Guidance

NIOSH has released guidance on Components for Evaluation of Direct-Reading Monitors for Gases and Vapors, along with an associated Addendum on Hazard Detection in First Responder Environments. These documents present the scientific background, the evaluation criteria, and the statistical methods needed for evaluation of direct-reading instruments. These two documents provide a useful summary of current knowledge for the successful evaluation and selection of monitors for effective assessment of gas and vapor hazards in occupational and emergency settings.  As technologies continue to change, NIOSH will continue its efforts in direct-reading by developing new methods and monitors and enhancing the guidance for their use and interpretation by inclusion in the NIOSH Manual of Analytical Methods

The Components and Addendum are part of the initiative on direct-reading methods and monitors that NIOSH began in 2008 to advance the development and use of twenty-first century technologies to anticipate, recognize, evaluate, control, and confirm safe levels of occupational exposure to hazards in time-sensitive ways. The unique requirements and applications of direct-reading methods to support public and worker health in both routine occupational activities and emergency preparedness continue to require improved laboratory and field test capabilities to ensure method or instrument performance and accurate interpretation of their results.

[1] A number of organizations have produced resources that may be relevant to the sensors development community. Links to these external resources are provided for informational purposes only, and the NNCO does not make any representation as to the accuracy of information, endorse any views expressed, or endorse or approve any commercial products or private interests that may be advertised or available on these sites.