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5.4 Regulatory Strategy

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.

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:
   • FDA Overview of Regulations – A high level overview of the FDA’s regulatory pathways and policies.
   • Device Advice – CDRH’s self-service site for obtaining information concerning medical devices and the application/submission processes.
   • Determination of Device Classification – Information provided by the FDA to help companies classify a device.
   • Device Classification Database – Searchable database provided by the FDA to aid device classification.
   • Request for designation – See CFR Title 21, Section 3.7 for when and how to submit a request for classification information. A useful document called “How to Write a Request for Designation (RFD)” is also available on the FDA website.
   • CFR Title 21: Food and Drugs – Parts 1 to 1499.
   • FDA 510(k) Database for Predicate Devices.
   • FDA PMA Database for Predicate Devices.

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 –
   • Device Advice.
   • European Commission Medical Device Sector Legislation – Overview of the European directives that govern medical devices.
   • MHRA Medical Device Directive – Additional information about regulatory processes in the EU.
   • Regulatory Affairs Professional Society – An online source for tools, coursework, guidance, and articles on regulatory subjects.
   • Professional Articles – Articles in leading professional journals (e.g., Kaplan et al., “Medical Device Development: From Prototype to Regulatory Approval,” Circulation, 2004, pp. 3068-3072) can provide valuable information and timely insights into the dynamic regulatory process.

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.