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Electronic Records - The Beginning of The Future of FDA Submissions

Imagine...the reviewer at FDA/ODE has a question on a sterility claim included in your 510(k) submission.  In the old days, he might have waited until the "89th day" and then mailed you from Rockville an interrogatory.  You FedEx your response the same day you receive the interrogatory.   The whole process should take no more than 14 weeks. 

But today, within a few seconds, he scrolls through your electronic 510(k) submission to the end where the attachments are found to find the electronically secured sterility validation report prepared by an accredited third party.  How does he know he has the original, "unmodified" report?  Easy.  The report was prepared by an accredited third party test lab which subscribes to a SEDMS (Secure Electronic Data Management System) already found compliant to 21 CFR 11 requirements.  There is a "lock" on the document which was engaged at the time the report was released to you the manufacturer.

Next, the reviewer has a question on the insulation properties of the device, an electrosurgical probe.  Within seconds, he drills down to the secure test certificate attesting to compliance with the IEC 601 standard from a well known test lab.  Finally, the reviewer wishes to look at the pilot production batch/device history record, to see if there were any anomalies as part of the production process.  Under 21 CFR 11, the reviewer is able to obtain the DHR over the Internet.  The 510k review takes hours compared to days.  And, if by chance, the data is not there, FDA is becoming equipped to receive the secured data over the Internet.  Now, replace the FDA with a FDA 3rd party reviewer similarly equipped and trained to complete the picture. 

Wait you say, this is not the FDA I know...Well, perhaps you aren't completely aware of some of the recent advances by FDA.  In fact, there is a FDA commitment to receiving ONLY electronic submissions within the next few years.  In fact, the FDA is gearing up for reviewing electronic batch records and has already begun this process on the pharma side. 

Now you're saying, "wow, that sounds great."  But how do I know FDA won't be prying into trade secret and proprietary areas where they have no jurisdiction.   The answer is also clear.  Under 21 CFR 11, there are "open" and "closed" SEDM systems.  Without a closed system,  your worst fears might be realized.

Now, just as with any other computerized system, FDA is not going to just permit the system to be installed and turned on.  You should know from (hopefully not painful) experience that FDA has  oversight of some computer systems, including those used in manufacturing, labelling, and QC, for example, and now those used to support compliance with 21 CFR 11.  What is entailed in relying on a SEDMS for 510k submissions as well as electronic batch records?  Procedures, training, logs, auditing, etc...all the things you have grown accustomed to from 21 CFR 820 (the QSr.)

For more information on our 21 CFR 11 services contact us by clicking  here.

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