Electronic documents case study
Electronic premarket review FDA submissions are today commonplace for pharmaceuticals and biologic products. Not so for devices. Because of our electronic publications expertise, Dr. Lillian Yin, FDA/CDRH/Office of Device Evaluation Director contacted us in early summer 1998, to request that we prepare the first-ever device premarket notification submission. A 510(k) premarket notification document, already in preparation, was converted to electronic form, submitted, and received FDA marketing clearance in September 1998.
Often, there are multiple versions of premarket review FDA submissions within a medical device manufacturer - before, during, and after the document is submitted to FDA for review. These multiple versions have a tendency to linger in an organization for years after the fact, until it is nearly impossible to determine which is the correct, complete version of the original submission.
While it may be overly burdensome to bring FDA filings, clinical investigational protocols, and other regulatory documents under the umbrella of formal Document Controls as envisioned by FDA's Quality Systems Regulations, active document management practices are required.
All of COASTAL's FDA submissions are now routinely authored in electronic form. When placed on the Company's intranet server, the electronic document serves as the document-of-reference, eliminating such confusion and redundancy.
