Regulatory Strategy and Submissions | Compliance | Audit Preparation + Remediation | Quality Systems | Design Controls | Due Diligence | Lean Processes | Regulatory Affairs Professional Society (RAPS)
#Startups - are you making the most of your FDA pre-submission? 🤔 You are scheduling pre-submissions with the FDA, aren't you? Aren't you?? If you aren't, you're missing out on a valuable opportunity to get in front of the FDA and ask specific questions relating to the regulatory process and requirements. It's almost like inviting the FDA to be part of your regulatory team. Almost. 😉 And while you can't ask them to review your data or how to design your studies or clinical trials, you can still get a lot of information out of the pre-sub. It's an opportunity to gauge the FDA’s current thinking on your device’s overall safety and effectiveness, and it can help improve the likelihood of a successful 510(k) submission. A pre-sub is especially valuable for devices utilizing novel technologies, or when a "first of a kind" indication or a new indication for an existing device is proposed. Which is exactly what a lot of startups do. Keep in mind that any discussions or agreements reached during the pre-sub are non-binding on the part of the FDA; however, unless something changes, they will usually honors decisions and discussions that were part of a pre-sub meeting. The pre-sub also provides a history and paper trail which can be considered during the 510(k) review process. So tell me again why haven't you scheduled a pre-sub with the FDA? 😉 #medicaldevices #regulatoryaffairs #FDA #compliance #quality #qualitymanagement #medtech #biotech Check out my FDA Pre-Submission Master Class video: https://lnkd.in/gUz5pVEB Read more about the importance of a presub meeting with the FDA: https://lnkd.in/gNw7Q8Ys Or just put some time on my calendar and we can chat about it in person: https://leanraqa.com/time.
This Presub phase is also well known in Europe, but here it is necessary to be represented by an American agent to discuss with the FDA. Let's bear in mind that the FDA do not have all the relevant medical specialists for your Medical Devices and private consultants are often used and join the scheduled video conference meetings.
The FDA is here to help you deliver safe, effective products. Schedule presubmission meetings to make the most of their guidance—don’t miss this essential step.
CEO chez NORAKER - Biomatériaux Innovants pour la chirurgie orthopédique| Fabricant spécialisé de verre bioactif
1moPre-submissions are indeed a valuable asset of the FDA. It takes time and expertise to understand their thinking and how to raise questions. Once this is acquired, definitely a must have, and so much more confidence to roll out the tests.