Self-certified 510(k) Clearance for Devices

Why Should You Attend:

Medical device manufacturers and 510(k) specification developers now have an expedited way to obtain 510(k) clearance for devices that otherwise require premarket submissions and review by the Center for Devices and Radiological Health (CDRH). Bypassing this required premarket review by CDRH will save time, help marketing roll outs of new products and reduce the cost of 510(k) preparation and the time involved. The action reflects CDRH’s commitment to a least burdensome approach to regulating devices. However, this is not a blank check for the device industry. The firms that may use the 510(k) self-certification process must meet certain criteria. The criteria can be a little “grey,” so the decision to use this alternative approach requires a rigorous self-evaluation by the manufacturer or specification developer. It also requires a diligent and forward-thinking regulatory approach.

Firms must develop criteria to determine whether they meet FDA’s qualification requirements to participate in this expedited 510(k) clearance process. This is not a blank check for market access. This program requires a firm to develop and implement a rigorous initial and ongoing quality assurance program. For example, using this express lane for market clearance carries prospective regulatory issues, such as when a “significant change” to specifications will require a new 510(k) or whether the change falls into a category that does not qualify for self-certification. As you can see, this is not a free-for-all. You must be able to assure the FDA that you in fact accurately use the self-certification tools. The program relies a great part on FDA trusting that the industry will not knowingly or unknowingly breach the criteria for using this alternative premarket clearance program. If FDA inspects your self-certification program you must demonstrate that you in fact comply with and actually qualify for the program. If you have any changes to your regulatory posture with the FDA, you need to establish and implement a responsive quality assurance program. A material mistake or a pattern of errors can jeopardize your chances to qualify or continue to use the self-certification program. You do not want to raise the slightest appearance that FDA cannot trust your ability to adhere to the criteria and parameters of this self-certification program.

Areas Covered in the Webinar:

• Description of the Self-Certification Program
• Advantages
• Disadvantages
• Prospective program obligations
• Regulatory Jeopardy

Who Will Benefit:

• Device regulatory affairs directors and managers
• Quality Assurance managers and staff
• Device specification developers
• FDA Device Consultants

Casper Uldriks
Former Associate Center Director, CDRH

Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. Mr. Uldriks understands how FDA thinks, how it operates, and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

Topic Background:

FDA requires a premarket review and clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FDCA) for devices that present a low to moderate level of risk regarding their safety and effectiveness. Over the course of the last few decades, the FDA has lowered the premarket review controls based on the track records of various devices. In many cases, the engineering and performance specifications incorporate the use of professional voluntary standards that are approved by an independent group of national and international experts. The FDA recognizes that adherence to the voluntary standards provide the agency the level of assurance it needs to satisfy its regulatory concerns for safety and effectiveness. As a result, the agency will permit the use of voluntary standards as an avenue through which device manufacturers required premarket clearance can be self-certified rather than by submitting the premarket submission to FDA for its review and clearance.

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