The Need

Even well-intentioned foreign device companies may underestimate their FDA compliance responsibilities for products they market in the U.S. In so doing they expose themselves to enforcement actions that can include costly suspension of export privileges. For small and midsized companies, the risk of compliance problems can impede their ability to establish strong U.S. distributor relationships. Common causes of such problems include:

• Over-reliance on ISO compliant systems to assure that FDA requirements are being met.

• Unfamiliarity with FDA interpretations of regulations and FDA enforcement practices that may not be obvious or intuitive.

• Superimposing ad hoc FDA compliance procedures on quality systems that were not designed to include them.

• Lack of resources to devote to relatively low volume exports to the U.S.

Typical Case Studies

A small European company was attempting to negotiate a medical device product line distribution arrangement with a large U.S. company. The prospective distributor had concerns about verifying that documentation of initial clearances and planned future changes would meet FDA requirements. The Client discussed the problem with Anson, which it had engaged to assist in preparing FDA submissions. Anson worked with the Client to develop an intermediary role wherein Anson would also audit and support future change documentation and assist in responding to the distributor's compliance inquiries. Anson helped this Client to secure and maintain a substantial U.S. distribution partnership.

A Japanese company set up a subsidiary to manufacture and market a medical device that had previously been distributed only in Asia. Anson was engaged to advise them in the process and assist in obtaining FDA clearance. The Client wanted the subsidiary to insulate them from FDA compliance responsibilities. Anson consultants proposed an alternative approach in which Anson would provide sufficient FDA compliance support to make the Client confident in assuming this responsibility. The Client decided to proceed with this approach, based on evidence of successful similar arrangements between Anson and other clients, The question of whether, when and how much to produce at the subsidiary can therefore be based on business rather than regulatory considerations. Anson helped this Client to significantly reduce the prospective initial costs and potential risks of its venture into the U.S. market.

A European medical device exporter had a history of FDA compliance problems, including a temporary suspension of exports following its last FDA inspection. When it was acquired by a larger European company, Anson was engaged to assess its current state of compliance. Anson consultants found an efficient and lean organization, producing products that were well-accepted in the market. However, design control, change control and other procedures did not conform to FDA requirements and were scantily documented. Anson helped the company to design and implement corrective actions without compromising its commitment to leanness and efficiency. An FDA compliance support role for Anson was the only added resource. The new system has passed a subsequent FDA inspection with no significant observations. Anson helped this Client to transform a compliance liability into an asset in its efforts to expand exports to the U.S.