FDA Reexamines 21 CFR Part 11

In an unexpected move, FDA announced it will at least temporarily scale back enforcement of 21 CFR Part 11 until it decides whether or not to revamp the regulation as part of its revision of Current Good Manufacturing Practices (CGMPs). CFR Part 11 regulates electronic records and signatures for all healthcare manufacturing processes including packaging.

On February 20, 2003, the agency issued a draft guidance, "Part 11, Electronic Records; Electronic Signatures—Scope and Application," that states the agency will "narrowly interpret the scope of Part 11" and will "exercise enforcement discretion" while it is being revaluated. The document can be viewed at www.fda.gov/cder/gmp/5505dft.PDF. For more information on the CGMP initiative, see this issue's Regulatory Focus column.

"We will not normally take regulatory action to enforce compliance with the validation, audit trail, record retention, and record copying requirements of Part 11 as explained in this guidance," the agency states. "However, records must still be maintained or submitted in accordance with the underlying predicate rules."

The move comes after industry ex-pressed concerns that compliance is too costly, that the requirements restrict the use of electronic technology rather than encourage it, and that they discourage innovation and technological advances without providing a significant public health benefit.

As part of the reexamination, the agency has withdrawn Part 11–related draft guidances on validation, glossary of terms, time stamps, maintenance of electronic records, and electronic copies of electronic records, as well as a compliance policy guide, CPG 7153.17. FDA says it intends to use the comments received on those guidances for future decision making.

During the reexamination, the agency will not normally take regulatory action to enforce Part 11 concerning the topics whose guidances have been withdrawn. Also, it will not enforce Part 11 with regard to systems that were operational before August 20, 1997, the effective date of Part 11.

The document narrows the scope of Part 11 so that it applies to records used in electronic format rather than paper format. If people use computers to generate paper printouts of electronic records and rely on the paper records to perform their regulated activities, that does not trigger Part 11. The paper records must meet all requirements of the applicable predicate rules.

FDA also offers guidance on when to validate computerized systems and when to apply audit trails.

Comments are due by April 28, 2003, and can be submitted in writing to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, or electronically to www.fda.gov/dockets/ecomments.