Saint Petersburg, FL – 09/07/2010) WIth more and more medical device and other Food and Drug Administration (FDA) regulated products being manufactured overseas, many foreign companies are having difficulty in understanding and hence complying with the US regulations.

 

Advanced Biomedical Consulting (ABC) has a long history of helping countless large and small US organizations with all types of regulatory submissions such as medical device 510(k)s, generation and submission of pharmaceutical annual reports, and facility registration and product listings (e.g. SPL). However, ABC has recently been inundated with requests from pharmaceutical, dietary supplement, and medical device firms in China, Pakistan, and even South America for help in getting their regulated products in the United States market. Therefore, ABC is now offering a new cost-effective and fast approach to help these foreign firms with FDA registration, approval to sell in the United States, and ongoing compliance.

How Do Overseas Firms Legally Sell Devices in the US?

 

While most US device companies understand at least some of the steps involved in getting their companies and products registered with FDA and legal for sale, the majority of foreign medical device companies do not understand the steps involved. The information below outlines the process for firms overseas looking to sell in the US.

Agent for the Agency

The first step in the process involves hiring a US Agent and informing the FDA who that agent is representing your firm. While this is a regulatory requirement, it is also a very good idea. The US Agent, who must reside in the US, is responsible for all communications bewteen FDA and the foreign firm. Therefore, it is crucial that this agent be experienced in communicating with FDA efficiently and effectively. From a financial perspective, be sure to hire a US Agent who will agree to represent your firm on a fixed annual fee basis (i.e. not on an hourly basis) as coordinating discussions between FDA and the firm (especially for audit scheduling) can add up rather quickly.

Company First

Before you can go for product approvals, you must register your company and its facilities with the agency. While this may appear to be simple, the rules have changed. The process is electronic now and must be submitted using a specific software "language". Many firms purchase software programs to assist with the process which can be a big initial sum of money. At ABC, we have elected to purchase the software in-house as we have several small clients with cash flow limitations and only a few registrations required annually.

Product Approvals

Now comes the hardest part in the process. Many foreign firms are manufacturing devices that are intended to be equivalent to a device already approved by FDA. While the space alloted here is not adequate to detail the process for establishing substantial equivalence, this task is the most crucial step in the process. Poorly executed 510(k) submissions and 510(k) submissions that are generated for a device that would clearly never pass the 510(k) process in the first place are big wastes of time and money. In fact, ABC quotes its 510(k) submission projects in stages, so client funds are not wasted for products that "as-built"/as documented would not meet the requirements for this regulatory program.

Preparation for Inspection

Once a product is approved or nearing approval, it is imperative, especially for foreign manufacturers, that the manufacturing facility is assessed against current industry practice and regulatory expectations.

As one of ABC's core competencies, our "mock inspections" complete with detailed recommendations for "fixes", we are confident that we can help firms avoid any initial and future regulatory hurdles associated with selling products in the US.

Conclusion

The process for obtaining US FDA regulatory approval and sutainable compliance can be managed and executed with few, if any, wrinkles in the road. However, these processes should not be embarked upon without a knowledgeable resource such as Advanced Biomedical Consulting that can offer expert advice on your behalf AND that can offer a hands-on approach to implementing every cost-effective suggestion.

For more information, please visit the ABC website, www.abcforfda.com, or contact ABC at the address or phone number below.

Advanced Biomedical Consulting (ABC), LLC

P.O. Box 76405

Saint Petersburg, FL 33734

Email: info@advancedbiomedicalconsulting.com

Phone: 888-671-4292

Website: http://www.abcforfda.com