Market comparator device
Substantially equivalent device
Affects the structure of the human body.
Cures or prevents disease in humans or animals.
Achieves its effect through chemical action on the human body.
Is recognized by the United States Pharmacopoeia.
FDA guidance documents
Good manufacturing practices
Clinical study requirements
Submission type (regulatory pathway)
FDA usually inspects a manufacturer’s facility prior to granting 510(k) clearance.
FDA requires clinical data with all 510(k) submissions.
All class II devices require 510(k) clearance.
The de novo pathway provides a route to 510(k) clearance for low and moderate-risk new devices.
Design reviews and/or phase reviews are required prior to market launch.
Manufacturers must monitor the performance of their devices following the market launch and make corrections as needed.
Changes to design input after market launch require FDA approval.
Clinical studies should be conducted with prototypes manufactured using methods and procedures expected to be used for ongoing production.
Pay FDA a User fee.
Submit a 510(k) application to a third-party reviewer.
Complete the facility registration and device listing prior to 510(k) submission.
Include a cost-effectiveness analysis with the 510(k) submission.
Investigational Device Exemption approval
Institutional Review Board approval
Establishing a quality policy for the company
Periodically reviewing quality control procedures.
Providing IRB approval
Hiring and training necessary quality assurance staff
Conducting laboratory studies to understand new technologies
Changing design input requirements
Building non-clinical prototype devices
Collecting human study data
During testing in support of future human studies
Upon deciding to develop a commercial product and approving product requirements (design input)
During studies to demonstrate proof of concept.
While validating a manufacturing process
Providing evidence that the Design Controls procedures were followed
Recording results of clinical trials
Archiving results of customer complaints
Documenting verification of sterilization testing
Study results can be used to establish device safety.
Institutional Review Board approval is required before starting a study.
Studies can be used to evaluate device concepts and refine a study protocol.
Study data can be used to manage patient care.
Document the change in the Device Master Record
Obtain FDA approval before implementing the change
Verify or validate the change before implementing
Review and approve the change according to an established design change procedure
Corrective and Preventive Action procedures are used during clinical studies to collect adverse effects information.
Corrective and Preventive Action deficiencies are one of the most frequently cited problems in FDA warning letters to manufacturers.
Corrective and Preventive Action procedures involve investigating potential product quality problems.
Changes identified as part of the Corrective and Preventive Action procedures should be verified or validated before implementation.
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