What is a Regulatory Strategy?
A regulatory strategy identified the most appropriate regulatory pathway for your medical device (e.g., 510(k), De Novo Classification Request or PMA). A regulatory strategy should include identification of key regulatory, testing (clinical and non-clinical), and labeling issues (claims and indications for use) necessary for the completion of the applicable regulatory submissions (Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File, etc.) according to FDA and CE requirements and regulations.
How to Prepare a Regulatory Strategy?
A review should be conducted of all available relevant information regarding the medical device that may affect the regulatory strategy. This review includes, but is not limited to:
- Device description and specifications
- Intended use and clinical applications, labeling claims, etc.
- Available non-clinical and clinical test data for the device
- Information pertaining to other products with similar applications or which incorporate similar technological characteristics
- The medical literature related to the specific clinical indication
- FDA/CE and international standards guidance documents.
Based on this review a regulatory strategy may be developed for obtaining FDA marketing clearance/approval and CE certification in accordance with current FDA & CE regulations.
Helpful tips when developing a Regulatory Strategy:
- It may be prudent to submit the Regulatory Strategy in a Pre-Sub/Q-Sub to obtain FDA concurrence on the proposed Regulatory Strategy.
- Developing a Regulatory Strategy from AI engines may be precarious. AI engine conclusions are not always accurate, especially when determining which devices may be suitable for the 510(k) regulatory pathway versus the De Novo Classification Request pathway.
How we can help?
- Stein – Regulatory Affairs Consulting assists companies in developing and implementing a regulatory strategy for obtaining FDA clearance/approval and CE certification under Regulation (EU) 2017/745 () and Regulation (EU) 20174/746 (IVDR), prior to commencement of the regulatory process.
