FDA Modernization Act Recognizes the Importance of Standards
Legislation allows companies to declare conformity to voluntary standards.
Michael H. Scholla, Chair, Health Industry Manufacturers Association (HIMA) Standards Task Group Chair, HIMA Sterilization and Packaging Test Group
As most in the medical packaging industry are aware, ANSI/AAMI/ISO 11607, "Packaging for Terminally Sterilized Medical Devices," was approved in March 1997. The accompanying guidance document, AAMI/ CDV-1 CBT1B-1, recently went to ballot, and the comments regarding it will be discussed at AAMI's packaging meeting in April. Industry's greatest concern is whether companies need to demonstrate conformance, and, if so, how they should implement the standard. The impetus for compliance, however, has recently been reinforced by new legislation.
On November 21, 1997, the FDA Modernization Act of 1997 was signed into law. This act contains provisions relating to all products under FDA's jurisdiction. In particular is section 204 on device standards, which adds a system for FDA to recognize national and international standards in product reviews. Under the system, a list of recognized standards will be published in the Federal Register. These standards can then be used in a declaration of conformity by companies to satisfy requirements for premarket approval (PMA) or 510(k) submissions. If FDA recognizes ANSI/AAMI/ISO 11607, companies could one day declare conformity to it in a premarket submission.
Working with the Health Industry Manufacturers Association (HIMA) Standards Task Group, FDA has developed a collection of answers to frequently asked questions to explain this section of the legislation and posted them on its Web site at http://www.fda.gov/cdrh/modact/faqost.html.
The first list of recognized standards was published February 19, 1998, on FDA's Web site at http://www.fda.gov/cdrh/modact/recstand.html. FDA plans to update the list in August. Proposals to include standards dealing with sterilization and packaging should be submitted to FDA by April 15.
Under the legislation, companies can potentially file a single-page 510(k) submission, with device labeling attached, stating that the device complies with one or more recognized standards. However, there are a few important ramifications. First, a declaration of conformity should not be taken lightly. While the data showing conformity would not necessarily be required for review of the PMA or 510(k), they must exist in the device maker's records. FDA has already indicated that it may take action against a firm if information in the declaration of conformity is falsified, or for a failure or refusal to provide data requested by FDA. Secondly, the standard must be complied with in toto without modifications, unless such modifications are noted in the application with the appropriate rationale and supporting data. Third, in instances where standards do not have specific performance requirements, data submission may be required. Fourth, compliance with these standards is voluntary. Device makers can propose different standards or alternative strategies to demonstrate the safety and efficacy of a device.
The key to making the use of such declarations successful is not the legislation but rather both the culture at the agency and the patience of industry. It is imperative that industry and FDA work closely to minimize the problems associated with implementation of the new legislation. Once implemented and fully operational, the role of standards in product approvals will greatly benefit the industry and the agency.
Michael H. Scholla is also medical packaging segment manager for DuPont Nonwovens (Wilmington, DE). For more information, contact Bernie Liebler at HIMA at 202/783-8700.