5.4 Regulatory Strategy

NeoTract: The Decision to Pursue a CE Mark

Ted Lamson, co-founder and CTO of NeoTract, explains why and when NeoTract decided to pursue a CE Mark.

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•  5.4 Regulatory Strategy •  NeoTract •  Ted Lamson • 

Gauss Surgical: Regulatory Landscape for the Triton System

Milt McColl, CEO, and Peggy McLaughlin, VP of Regulatory Affairs, discuss the initial regulatory landscape for Gauss Surgical’s Triton fluid management system and how the company ended up on the de novo pathway.

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Gauss Surgical: Embarking on the De Novo Pathway

Milt McColl, CEO, and Peggy McLaughlin, VP of Regulatory Affairs for Gauss Surgical, describe some of the challenges associated with their switch to the de novo pathway.

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Getting Started

For innovators considering how to select and begin navigating a regulatory pathway early in the biodesign innovation process, the resources provided in the Getting Started section of chapter 4.2 will be useful. For regulatory issues that come into play at a more advanced stage of a development program (arising in the context of a start-up or existing company), the following steps are recommended.

Validate Device Classification and Regulatory Pathway

What to Cover

Before investing in the creation of a detailed regulatory strategy, it is a good idea to validate that the device has been properly classified. If a device classification cannot be determined, classification information can be requested from FDA (section 513(g) of the Food, Drug & Cosmetic Act describes this process). Due to the growing complexity of the device market, the number of such requests has been steadily increasing over time.

Where to Look

Review the classification determination as outlined in 4.2 Regulatory Basics (if needed). Look at competitors and similar devices used in different therapeutic areas. Attend major specialty meetings and browse the exhibit floor for ideas about device classification and possible predicates. In addition, the following resource can be used to gather relevant information:

Develop a Regulatory Strategy

What to Cover

Involve a regulatory expert and all company functions, especially design, quality, clinical, and marketing, in the development of a regulatory strategy that effectively addresses the chosen path. For either a 510(k) or PMA path, be sure to schedule a pre-submission meeting with FDA to launch the strategy on the right foot.

Where to Look

Modify and Monitor Regulatory Strategy

What to Cover

Monitor the regulatory strategy being pursued on an ongoing basis. Be proactive in identifying issues and addressing them before they develop into problems that could affect the company’s relationship with FDA. Consider withdrawing any FDA submission that encounters serious difficulties and could be a candidate for a “not substantially equivalent” (NSE) determination under the 510(k) pathway. Maintain open and ongoing communication with FDA to avoid surprises and ensure a constructive, mutually beneficial dialog between the agency and the company. Actively work to avoid the common regulatory pitfalls summarized in online Appendix 5.4.1.

Where to Look

Stay abreast of new regulatory-related information made available in the popular press, professional journals, and on the FDA website.