I'm looking for information about

Can't find what you're looking for? You may need to login to see more documents.

Clinical Trials with No/Low Enrollment: Guide for Departments
CBR Use Proposal Form
Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources
Data & Biospecimen Sharing Checklist
Statement of Practice: Remote Study Procedures
Secondary Use Research
Michigan Medicine Clinical Research Position Statement
Guidelines for Studies Conducted Through MCOHR and the Dental School
Device Study Procedure Flow
Retention of Research Data/Biospecimens

Medical Device

  • A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body (that is, not a drug or biologic). Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment. (OHRP)
  • A medical device is any instrument, apparatus, or other similar or related article, including component, part, or accessory, which is… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals… The range of devices is broad and diverse, including bandages, thermometers, ECG electrodes, IUDs, cardiac pacemakers, and hemodialysis machines. For further information, see the following FDA guidance: