5.4 Regulatory Strategy

Chapter 5.4
Additional Resources

The information presented in Chapter 5.4 is presented to help innovators develop a regulatory strategy and address regulatory issues that arise at a more advanced stage of device development (i.e., in the context of a start-up or existing company). The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started.

Validate Device Classification and Regulatory Pathway
  1. 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 device classification cannot readily be determined, classification information can be requested from the FDA under section 513(g) of the Food, Drug and Cosmetic Act.  Due to the growing complexity of the device market, the number of such requests has been steadily increasing over time.  More information about when and make a submission is available in the Code of Federal Regulations (CFR), Title 21, Section 3.7 Request for Designation.
  2. 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
  1. 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-meeting with the FDA to launch the strategy on the right foot.
  2. Where to Look

Modify and Monitor Regulatory Strategy
  1. 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 the FDA. As mentioned previously, 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 the 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 Table 5.4.3 in the book.
  2. Where to Look – Stay abreast of new regulatory-related information made available in the popular press, professional journals, and on the FDA website.

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