Medical Device Link.

Originally Published MX January/February 2005

IT IN HEALTHCARE

If a coalition of regulated industry associations has its way, FDA's regulation on electronic records and signatures may soon be a thing of the past.

In September of last year, a group calling itself the Industry Coalition on 21 CFR Part 11 submitted a citizen petition to FDA requesting that the agency "revoke 21 CFR Part 11 in its entirety, and pursue implementation of electronic record and signature systems through the application of Government Paperwork Elimination Act (GPEA) standards and the enforcement of predicate rules."

In its petition, the coalition argues that "the prescriptive approach adopted in Part 11 has failed to adapt to changing technologies and has placed an unnecessary burden on regulated entities."

Summarizing its proposal, the coalition notes that, before the issuance of Part 11, FDA held the view that "a separate rule making process was required to ensure electronic records and signatures could be accepted in satisfaction of agency regulations. At the time Part 11 was proposed, FDA's position was that predicate rules did not permit the use of electronic records and signatures."

But according to the coalition, the basis of this view was fundamentally changed by the 1998 enactment of GPEA. "Under GPEA, federal agencies are required (as of October 2003) to accept electronic records and signatures in satisfaction of any agency regulation requiring the maintenance or submission of information."

Consequently, the coalition argues, the Part 11 provisions on both electronic signatures and electronic system controls are superseded by GPEA. "No specific statutory mandate required the issuance of Part 11, and the Part 11 regulations no longer serve any independent public health purpose. Rather than attempting to rework this unwieldy regulation through the issuance of guidance documents, FDA should revoke Part 11."

But not everyone agrees with the coalition's views. In October, the computer validation initiative committee of the Society of Quality Assurance (SQA; Charlottesville, VA) submitted an opposing opinion for FDA's consideration. Contrary to the coalition view, the committee expresses the judgment that "Part 11 does add value and is not redundant with other regulations."

SQA describes itself as "an international organization of nearly 2000 research quality assurance professionals" who are tasked with representing the regulatory and compliance point of view within their organizations. Members of the SQA computer validation initiative committee specialize in "assuring consumer safety, product quality, and data integrity when these goals are managed via computer systems."

In its submission to FDA, SQA argues against the coalition's call to rescind Part 11. "The industry coalition has only cited references taken from manufacturing and quality systems regulations, although Part 11 is also applicable to laboratory and clinical regulations," the committee writes. "The data submitted from the research and development process are a significant and critical part of the submission and product evaluation process performed by FDA to approve new medicines. These areas must not be ignored in any debate concerning the future of Part 11."

While admitting that FDA's regulation could be improved and updated, the SQA committee writes that it is "not aware of any evidence that Part 11 is unduly burdensome or that it has inhibited technological innovation."

Moreover, the committee argues, GPEA and Part 11 serve different functions. "The scope of the GPEA focuses on the submission and maintenance of records after they are transmitted to a federal agency. The scope of Part 11 includes the creation, modification, maintenance, archival, and retrieval of those records prior to submission to the agency," the committee writes.

There is no evidence that GPEA was intended to supersede Part 11, says the committee, or that the Office of Management and Budget has interpreted the act in that way.

With such conflicting views about Part 11 in the air, FDA is likely to tread carefully before determining a course of action. So far, the agency has not announced its schedule for responding to the industry coalition's petition. To keep track of the growing number of documents submitted in connection with the petition, visit the FDA Division of Dockets Management home page at www.fda.gov/ohrms/dockets and search for Docket 2004P-0429.

Copyright ©2005 MX