What is required of an FDA Specifications Developer?
The term “specifications developer” is a legal term used by the U.S. Food and Drug Administration. To become one requires companies to meet certain minimum requirements and put in place specific quality systems and procedures. While this blog is not meant to be an exhaustive review of all requirements, it is intended to shed light on the subject and add some definition to the often used phase.
Keystone Solutions Group specializes in new product development and contract manufacturing for medical devices and assists many of our clients through the process. Many of our projects start with us asking our perspective clients “So what do you want to be when you grow up?” What we mean by this question is usually, what type of company do you want to be (OEM or Specifications Developer) and then Keystone can advise them as to the requirements necessary to meet FDA guidelines. If you Google search Medical Device Specification Developer, there are about 8,000,000 results. “The” reference, however, is the FDA, and the FDA defines a Specifications Developer as:
Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
Sec. 820.5 Quality system.
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.
Sec. 820.3 Definitions. (o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.
On the FDA website, www.fda.gov, the agency provides a wide range of guidance documents to help those who are developing new products or commercializing medical device technology and need to know how to best align their company to properly document, manufacture, and market their medical devices and meet FDA requirements. The emphasis is on the word “and” in the previous sentence. In medical device development, it’s never “all you have to do is” and it’s rarely simple. However, there is a pathway going forward and specific steps in the process that must be navigated. Once the device classification is determined (another future blog topic) and the specification developer meets the requirements, it can register with the FDA, list its product(s), and pay the proper fees based upon device classification and company size.
Based upon guidance documents, and even though almost all aspects of the process can be outsourced, someone in the chain has to be accountable in order to satisfy the FDA. Most of the governing requirements for this system are found in FDA's quality system regulation (QSR), published in 21 CFR 820. An entrepreneur or start-up company can decide to operate as a “virtual” company and not have to establish a bricks and mortar space or hire a staff of engineers and experts. The company, however, still has to establish certain relationships and contractual agreements with partners that can help them meet the requirements.
Of course all of this information and guidance is great as long as it leads to a better understanding of “why” would a company chose to be a specifications developer as compared to other operating arrangements. Based upon past successes, and in our opinion, operating as a specifications developer allows companies to focus on their strengths and not get bogged down with infrastructure. It also allows companies to leverage a broad range of expertise available through outsourcing.
In other words, if you set yourself up as a specifications developer, you could have a billion-dollar medical device enterprise and never manufacture one dollar’s worth of product! You can also be highly flexible while the product development is taking place and can concentrate on successfully marketing products and building sales channels, knowing that they’ll meet and exceed requirements should the FDA ever decide to come knocking!