Are you getting closer to submitting a medical device for successful market clearance to the U.S. Food and Drug Administration (FDA)? Communication is the essence of all regulatory challenges associated with the mire of detail and information that is required for an approved clearance for a 510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA), Humanitarian Device Exemption (HDE), Investigation New Drug (IND) or Biologics License Application (BLA). So, how can transparency help?
Use transparency to create a venue for a “pre-sub” review for submission. That’s what the FDA’s Center for Devices and Radiological Health (CDRH) did in September of 2017. Submission roundtables can now be scheduled that allow a company to discuss achieving results with the right data and the right orientation of that data to the FDA.
Here are the general criteria for a pre-sub discussion (item #3/Pg.16, Guidance on Pre-subs, 9/30/2017):
•Recommendations for device types not specifically addressed by a guidance document.
• Recommendations for nonclinical or clinical studies not addressed by a guidance document.
• Requests to use an alternative means to address recommendations specified in a guidance document.
Email CDRH-Guidance@fda.hhs.gov to receive a hard copy of the guidance, document number 1677.
It’s important to note that many other ways of communicating with the FDA are clarified in this document that are and aren’t pre-submission predicated for discussion. One example of a meeting not in the pre-sub category is, “meetings or teleconferences requested by either the applicant or FDA to discuss FDA requests for additional information for a marketing application under review or on hold (RTA) (See Section III.E Submission Issue Meetings).”
This 57-page document is a must-read for anyone involved in a device submission orientation internally or externally for a new device. Concepts regarding risk assessment studies and the nature of determination is a key part of this guidance. Finally, there is a good help document in Appendix 2: Q-Sub Acceptance Checklist as a guide to a pre-sub determination and the context of a submission. This guidance entails many ways in which the FDA intends to communicate with the industry and the scenarios in which the FDA will engage in transparency with industry. Good luck!
Walt Murray is a quality management and regulatory affairs professional with more than 32 years working with internationally recognized and highly-regulated companies, including J&J, Merck, Pfizer, Stryker, USANA and Del Monte Foods. A Six Sigma Black Belt, Murray is certified (CSSMB) in quality and environmental systems auditing (RAB/QSA/IATCA/IRCA), critical-thinking skills (CTS Facilitator) and process control (SPC/SQC). Having personally performed more than 350 1st/2nd/3rd-party audits for a variety of Fortune 500 life sciences companies, Murray has hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada (CMDR). Walt is based in Salt Lake City, Utah, and works as an independent expert as he supports regulated clientele for GMP, GLP, IVD, GCP and the cross-disciplinary development of MDSAP companies.
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