Medical Devices

FDA defines the term “medical device” as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1) recognized in the official National Formulary, or the U. S. Pharmacopoeia, or any supplement to them, 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose.

Medical devices include thousands of health care products, from simple articles such as thermometers, tongue depressors, and heating pads to intrauterine contraceptive devices, heart pacemakers, and kidney dialysis machines. The term devices also includes component parts, or accessories of devices, diagnostic aids such as reagents, antibiotic sensitivity discs, and test kits for in vitro diagnosis of disease and other conditions. It is now always easy to determine whether a product will be considered by FDA to be a drug or device. CCS offers a range of medical device consulting, submission and auditing services including:

  • Quality Systems Compliance
  • cGMP Compliance
  • Regulatory Submissions
    • IDE<,510 (k)
    • PMA
    • HDE
  • Bioresearch Monitoring ∇
    • Clinical Trials
    • Institutional Review Boards (IRBs)
    • Sponsor Monitor
    • Clinical Investigators
  • MDR Procedures and Reporting Requirements
  • Validation ∇
    • Process
    • Software
    • Equipment
  • FDA medical device policies and procedures

  • Product recall advice and assistance
  • U.S. Agent Services
  • FDA Regulatory Correspondence and Responses
  • Product Registration and Listing
  • FDA Inspection Audits
  • Seminars and Training

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