510K and FDA 2892 Medical Device Listings


	Prelude Computer Solutions, Inc.

MEDSTAR for 510K and FDA 2892 Medical Device Listings

FDA-2892, FDA-2891, FDA-3514 CDRH Premarket Review Submission Cover Sheet

MEDSTAR for medical devices tracks the 510K from the entry and issuance of the CDRH cover sheet to the clearance of the 510K. MEDSTAR also creates the FDA 2892 Device Listing.

The MEDSTAR application provides a repository for storing, tracking and reporting on all medical device products containing both internally managed data and data supplied by the FDA.

All of your corporate manufacturing plants and other sites are entered into the Site master as well as all the personnel at the site involved in the regulatory compliance process. The FDA 2891 Initial Registration of Device Establishment is printed from this site information. The site master information is used to enter data on FDA forms that report on owner/operator information and manufacturing plant information. This insures accurate and consistent reporting and is much easier to enter.

MEDSTAR provides for entering and managing other critical data in the master files for manufacturing List Numbers, Components, and Predicate Products. The 510K Master form provides for entering all information relevant to medical devices tracked by this department.

The primary functions for this form are:

For Tracking

Maintain a record of all the medical devices currently or previously marketed and all products being reviewed or in the process of being approved by the FDA.
Maintain a cross reference of all 510Ks and medical device List Numbers
When a product is approved to be marketed by the FDA, import that information from the Center for Devices and Radiological Health (CDRH) and create a related record in the MEDSTAR database.
Capture all site related information in a Site Master file. This includes the following: Applicant or Sponsor, Submission Correspondent, and the Manufacturing, Packaging and Sterilization Sites.

For Reporting and Submissions

Capture required information for creating the FDA 3514 CDRH Premarket Review Submission Cover Sheet. This includes the ten types of submissions (PMA, PMA Supplement, PDP, 510K, Meeting, IDE, Humanitarian Device Exemption, Class II Exemption, Evaluation of Automatic Class III Designation, and Other Submission).
Create the FDA form 2892 Device Listing submission and capture all the pertinent data concerning the submission. There can be multiple submissions for one device.
Provide an audit trail of all information entered on the 510K Master.
Log all relevant correspondence and communications concerning this device.

MEDSTAR is a secure database and all entry and editing of information is captured in an audit file. Provision is made for linking essential files and documents to related records. Several statistical reports are provided and the reporting and inquiry capabilities can be expanded by the user as the departments needs evolve.

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