FDA Regulations

The US Federal Drug Administration (FDA) is responsible for regulating and approving a wide range of food and medicinal products in the USA including:

  • Food
  • Drugs
  • Medical Devices
  • Vaccines
  • Blood & Biologics
  • Animal & Veterinary
  • Cosmetics
  • Radiation-Emitting Products
     

Electronic Signatures:
http://www.fda.gov/ohrms/dockets/98fr/5667fnl.pdf
 

The regulations for medical devices are: 

Medical Devices
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312
 

Print  
Download - Electronic Signatures

Guidance for Industry Electronic Records, Electronic Signatures - Scope and Application.

 

The details of the documentation for the electronic signatures is available by clicking on the image above or downloading from the FDA website (link opposite)

Download - Systems - Clinical

Guidance for Industry - Computerized Systems used in Clinical Investigations (2007)

 

This guidance document represents the FDA`s current thinking on the use of computerised systems in Clinical Research. It covers the use of Standard Operating Procedures (SOP`s), Source Documentation, Access Control, Audit Trails and Date and Time Stamps.