Q18. According to CFR21.820, what happens if a manufacturer offers a medical dev
ID: 96139 • Letter: Q
Question
Q18. According to CFR21.820, what happens if a manufacturer offers a medical device for import into the United States and refuses the completion of a Food and Drug Administration inspection of the facility making the device?
Q19. To whom does CFR21.822 apply? How does someone know if CFR21.822 applies to them?
Q20. Is it possible for the FDA to grant marketing approval for a new drug product where safety has been established in animal studies alone?
Q21. When was the Pre-IND Consultation Program started? What was it designed to do?
Q22. How many divisions within the FDA are currently part of the Pre-IND Consultations Program?
Q23. Are written responses from the FDA ever deemed equivalent to a meeting?
Q24. How do you request a meeting with the FDA?
Q25. What is a type B meeting? How long does it take to schedule this type of meeting?
Explanation / Answer
Answer 18. If a manufacturar refuse to completion of a FDA inspection of the facility making the device, according to act 801 (a), facility do not confirm the requirement of 520 (f) of the act means failure to adhere with this act provide device adultered under the section 501(h) and regulatory action taken against a person or device responsible for failure.
Answer 19. Device regulated by biological evaluation and research submitted to FDA ,center for biological evaulation research, For device regulated by center for drug evaluation and research submitted to drug evaluation and research. Unique document number assigned to each submission through which CFR21.822 know about the submission.
Answer 25. Scheduled within 60 days of FDA receipt of the written meeting request. Type B meeting is a pre-investigational new drug application meetings involves certain end of phase of 1 meetings, end of phase 2 and pre-phase 3 meetings and pre- new drug application meeting.
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