robert.beck
Involved In Discussions
Does anyone have any experience with or opinion about completing one of these forms for a non-recognized standard?
Here is the situation: the American Academy of Sleep Medicine (AASM) publishes a Clinical Practice Guideline. This guideline is described by AASM as "provides comprehensive recommendations for the evaluation, diagnosis, treatment, and follow-up of patients with sleep disorders."
We followed the guidelines when developing a medical device. What are the pros and cons of claiming conformity to these guidelines using form 3654 in a 510(k) application? Obviously, we can claim conformity without using the form by making statements and providing data. I'm just wondering if anyone has done something similar in a 510(k) and if so, how did FDA respond. Opinions and comments also welcome.
Here is the situation: the American Academy of Sleep Medicine (AASM) publishes a Clinical Practice Guideline. This guideline is described by AASM as "provides comprehensive recommendations for the evaluation, diagnosis, treatment, and follow-up of patients with sleep disorders."
We followed the guidelines when developing a medical device. What are the pros and cons of claiming conformity to these guidelines using form 3654 in a 510(k) application? Obviously, we can claim conformity without using the form by making statements and providing data. I'm just wondering if anyone has done something similar in a 510(k) and if so, how did FDA respond. Opinions and comments also welcome.
