FDA OK's rule on medical devices.
After nearly three years of consideration, the U.S. Food and Drug Administration (FDA) issued a final rule last October that will institute a new system for ensuring the quality of medical devices as they are manufactured. The lengthy new regulation outlines a comprehensive set of current good manufacturing practices (CGMP's) that must be followed during each stage of the manufacturing process, including design.
Many of these provisions were adopted so that U.S. CGMP's would comply with ISO 9001 standards and, as such, will require close cooperation between medical device manufacturers and their suppliers - even in cases where the manufacturer produces its own roll goods. The regulation will become effective on June 1, 1997.
The FDA originally released the CGMP revisions as a draft rule on November 23, 1993 and then issued a "working draft" final rule in July 1995. In its draft form, there were a number of provisions that concerned members of the nonwoven fabrics industry. Of greatest concern were provisions that would have extended CGMP regulations for finished devices to their components as well.
This meant that roll goods manufacturers who supply the medical device industry would have been forced to undergo periodic FDA inspections and other bothersome regulatory requirements, to which they had not been subject before. There was also concern over where the regulatory line would be drawn with regard to components. It was not clear, for instance, whether the FDA would go beyond roll goods as component parts and seek to impose CGMP requirements on fibers, binders andother materials used to manufacture the roll goods themselves.
Since the regulation applies to any product that is classified as a medical device by the FDA, members of the nonwovens industry were not alone in their concerns over the scope of the proposed rule with regard to components. In the end, the FDA backed off the issue when it finalized the regulation by stating that: "This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance."
The FDA also notes that purchasing control requirements contained in the final regulation (under Section 820.50) would sufficiently ensure that finished devices are manufactured from quality components.
In addition to concerns over the component portion of the draft rule, other issues needed to be addressed on behalf of the nonwovens industry. In fact, INDA, Association of the Nonwoven Fabrics Industry, raised a number of points in letters and discussions with FDA officials as the final rule was being developed.
The proposed rule, for instance, would have allowed FDA employees to review and copy the quality audit reports that are written as part of a medical device manufacturer's assessment of their suppliers or contractors. This would be a big difference from current FDA policy, which requires device manufacturers to certify that such audits have been conducted and that necessary corrective action has been taken.
INDA members were especially concerned that, had the FDA given its inspectors access to these documents, it would limit the amount of information shared between suppliers and manufacturers. That is, if either the manufacturer or the supplier viewed these documents as the potential basis of "regulatory liability," they would be less likely to provide full and complete information in the audit papers.
The FDA agreed with INDA and, in the final rule, did not seek to expand its access to quality audit reports. The agency did, however, leave itself the ability to revisit the issue if it determines that access to these documents by its employees will improve the manufacturing process.
INDA also commented on provisions of the draft rule that would have required manufacturers to document any changes to the specifications, methods or procedures used in the production of medical devices. The FDA included these provisions in the draft rule to ensure that such changes wouldn't alter the device to the point that a premarket notification or premarket approval would be required.
INDA noted that medical device manufacturers are already responsible for determining if premarket notifications or approvals are needed due to changes in their products and that this provision could require costly and unnecessary intervention for the most minor, routine process changes.
FDA agreed with INDA and, in finalizing the regulation, moved the provision from the "document controls" portion of the draft regulation to the "production and process controls" portion of the final rule. The FDA further stated that changes to design specifications. undertaken at any time during the manufacture of a medical device must conform with "design controls" sections of the final rule.
Also, while the new regulation requires that such controls be implemented by medical device manufacturers, the FDA will allow a full year (until June 1, 1998) before it takes enforcement actions. The requirements will apply, however, to any designs developed, or in the developmental phase, as of June 1, 1997.
Now that U.S. CGMP regulations are similar to ISO standards, communication and documentation will be critical issues for those in the nonwovens industry who are involved in the manufacture of medical devices or in components designed for use in medical devices. With only a few months to go before the new standards take effect, many members of the nonwovens industry have already undertaken a thorough review of their provisions and have been working with their suppliers or customers to ensure that they will be in compliance. Those who have not taken these steps are encouraged to do so.
Peter Mayberry is the director of government affairs for INDA, Association of the Nonwoven Fabrics Industry. He works out of the law offices of Kutac Rock in Washington D.C. This Capital Comments column appears monthly in NONWOVENS INDUSTRY.