FDA Importer Guidance For Devices

The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food recalls.

Off the record, current, and former FDAers have told us that they know they’ve been understaffed and underfunded in recent years, and that their enforcement capabilities often weren’t up to the task.

With a new president and renewed focus on government regulation in Washington, it’s likely that pressure from the White House and Capitol Hill will spur the agency to be more active this year and in the next several years, experts say.

A proposed new law is being advanced on Capitol Hill: The Food and Drug Administration Globalization Act of 2009. Among other new proposed enforcement teeth for the FDA, it calls for the creation of an up-to-date registry of all drug and device facilities serving American consumers. It also requires all domestic drug and device facilities and foreign facilities exporting to the United States to register with the FDA annually and pay a registration fee.

A more proactive FDA?

With well-documented problems related to Chinese imports as a starting point, experts note that in 2009 the FDA is trying to show that it can be more proactive when it comes to inspections. At the same time, the industry is putting the device industry, among others, on notice that it will hold those at the top accountable for any import problems associated with their products.

The FDA’s recent Good Importer Practices draft guidance is a good case in point. Issued in January, it was open for public comment until April.

“This is part of a broader effort, pushing responsibility for manufacturing on the manufacturer,” says Mark Mansour, an attorney with Bryan Cave LLP in Washington, D.C. The FDA is saying they will inspect and enforce more, but that manufacturers are counted on as the “first line of defense,” he adds.

Serious business

“Device firms should take this very seriously,” Mansour says, adding that Congress is likely to build on what the FDA seeks in this guidance.

“Think of it as the FDA’s wish list,” says Frederick H. Branding, R.Ph., J.D., a partner with ReedSmith in Chicago and active in device, drug, and combo product issues and clients. But he stresses that much of what the FDA suggests here is already on the books in one place or another. Translation: Device firms would be wise to take this guidance to heart and follow its requests.

As the FDA puts it in the guidance:
“This draft guidance document would not establish legally enforceable rights or responsibilities. Instead, this guidance document, when finalized, would describe the current thinking of U.S. federal departments and agencies on a topic, and readers should view it only as recommendations, unless the document cites specific regulatory or statutory requirements. The use of the word ‘should’ means that something is suggested or recommended, but not required. Nothing in this document is intended to affect the importer’s responsibility to comply with all applicable requirements found in U.S. statutes and regulations.”

Responsibility begins at the top

“The FDA wants importers to take more responsibility,” Branding says. And the FDA is making it clear that “responsibility begins and ends at the top” of the company’s organizational chart.

This Good Importer Practices guidance is intended for use by the importer that initiates or causes the entry or attempted entry of foreign-sourced products into the United States or the reimportation of U.S.-made products (American Goods Returned) for commercial purposes or distribution. However, importers who aren’t bringing in a product for commercial purposes or distribution should have adequate control measures to prevent the distribution of the product into U.S. markets unless the product meets all U.S. requirements, the FDA says in the guidance.

Parties other than importers associated with import transactions might also be subject to U.S. requirements. To promote safety of imported products, these parties (e.g., retailers, manufacturers) should also “carefully consider the guidance set forth in this document,” according to the FDA.

Hazards that may place consumers at risk can arise at any point during a product’s life cycle. This guidance document provides recommendations concerning preventive controls firms can implement to mitigate such hazards, and to help ensure imported products are safe and are compliant with U.S. laws and regulations.

The recommendations contained in this guidance are designed to anticipate the sources of product hazard that importers may face. FDA says it recognizes that different goods carry different risks and potential hazards. “We encourage importers to tailor these recommendations to their specific situations by adopting the criteria that will most effectively manage the risks that they face and best protect consumers. Further, we recognize that the size and scope of importers’ resources vary enormously. As such, large-scale importers may have greater challenges but also greater resources and influence to minimize risk,” the FDA says in the guidance document.

It also notes that, while some of the following recommendations may be impractical for some small-scale importers, each importer should take appropriate steps to ensure the safety of its products.

In general, the FDA recommends that importers:
• Know the foreign firms that produce the products they purchase and any other firms with which they do business and through which such products pass (e.g., consolidators, trading companies, distributors)
• Understand the products that they import and the vulnerabilities associated with these products
• Understand the hazards that may arise during the product life cycle, including all stages of production
• Ensure proper control and monitoring of these hazards

 

Importers should consider instituting practices to identify and minimize risks. Determining the sources of greatest potential risk in a product’s life cycle helps to direct attention to the areas where they can have the greatest positive effect to ensure the safety of the product.

Importers should put into place controls for known vulnerabilities, such as microbiological contamination and product defects, and monitor for other risks, such as counterfeiting or intentional contamination.

Good importer practices—principles and recommendations

Because of the wide variety of products and their production processes, the regulatory systems that apply to particular products, and the range of product and importer relationships, it’s difficult to develop a set of detailed recommendations that fits every product. However, in developing these recommendations, members of the FDA’s working group say they considered the complexity of product life cycles and production processes, as well as the different regulatory frameworks to which various products can be subject. Not all recommendations are appropriate or feasible for every product and for every importer, but importers should identify and understand potential risks before deciding to import a particular product.

The Guidance states: “We also recognize that importers could already be using other best practices that provide assurance that their products are in compliance with U.S. requirements, and thus are not advising that these importers necessarily modify their practices. However, we believe importers who follow these Good Importer Practices may be less likely to import products that may be harmful to U.S. consumers, and, as a result, may, in some cases, facilitate admissibility determinations, and, therefore, expedite the entry of their products into the United States. However, following these Good Importer Practices does not guarantee compliance with applicable U.S. requirements, or mean that the Government cannot or will not take regulatory or enforcement action regarding compliance with U.S. laws and regulations.”

These Good Importer Practices are broadly organized under four guiding principles:
1. Establishing a product safety management program
2. Knowing the product and applicable U.S. requirements
3. Verifying product and firm compliance with U.S. requirements throughout the supply chain and product life cycle
4. Taking corrective and preventive action when the imported product or firm isn’t compliant with U.S. requirements

Emphasis on CAPA

While there are no real shockers in the guidance, it strongly reaffirms the FDA’s desire that a medical device manufacturer have a strong corrective action plan (CAPA).

After firms have detected a problem, and have managed the process to minimize harm, the importer should take corrective and preventive action to ensure similar problems do not recur. By taking the appropriate corrective and preventive action when an imported product or firm isn’t compliant with U.S. requirements, importers can enhance their ability to minimize potential hazards to their consumers.

The FDA recommends importers undertake the following actions:

• Establish procedures for developing corrective action plans, and for taking corrective and preventive actions if noncompliance with a U.S. requirement or a safety concern should arise. Address the potential need for disposal/destruction or export of noncompliant products, consistent with applicable U.S. statutes and regulations.
• Identify and investigate the root cause of noncompliance with U.S. requirements for products they import, or by foreign firms with which they do business.
• Take steps to remediate and prevent harm from present and future shipments, and to ensure noncompliance and safety problems don’t recur. These corrective action plans must, of course, be consistent with the appropriate U.S. agency’s regulations. They could, for instance, include product relabeling, product reworking or further processing, product export or destruction (if the violative product is already at a U.S. port-of-entry or in U.S. commerce), or a decision not to offer the product for entry into the United States. Proper corrective action plans are based on practices that either ensure the product is in compliance when offered for entry into the United States, or that will correct any problems prior to marketing in the United States.
• Work with the noncompliant firm to meet U.S. requirements, or stop conducting business with that firm.

 

Conclusion

“I think this is just another step forward” for a revitalized, perhaps more aggressive FDA, says Branding.

The FDA clearly expects medical device manufacturers to be vigilant about quality, and about catching and correcting mistakes and complaints. “The model has shifted,” Branding says. The FDA today wants device manufacturers to build quality into their products from the very beginning, and to spot procedural problems very early in the product life cycle. It’s a huge undertaking for the FDA and for industry.

The good news is that except for the smallest medical device firms, the financial, legal,  and regulatory burdens of compliance are manageable, Mansour says. “If your medical device firm has sales over $1 million, you should be able to handle this.”

Bottom-line: If you are committed to producing safe, quality products, these are clearly guidelines you should meet or exceed.

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