What is a Q-sub FDA?
Page 13. Q-Sub Type: Pre-Submissions. • A formal written request for feedback from FDA to help. guide product development and/or application preparation.
What are Q submissions?
The Pre-Submission allows you to request formal feedback on your medical device before you make the move to submit your 510(k). This is known as a Q-Submission, which under the guidance published by FDA, allows you to request the following: Pre-Submission (what we’re focusing on here) An informal meeting.
What is the meaning of FDA?
The Food and Drug Administration
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
What is a 510 K premarket notification?
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act.
What is discipline review letter FDA?
Discipline review letter (DRL) – means a letter used to convey preliminary thoughts on possible deficiencies found by a discipline reviewer and/or review team for its portion of the pending application at the conclusion of the discipline review.
What is Type C meeting?
A Type C meeting is any meeting other than a Type A or Type B meeting between CBER or CDER and a sponsor or applicant regarding the development and review of a product. Type C meetings should be scheduled to occur within 75 days of FDA receipt of the written. meeting request.
What is the mechanism of section 513 ( G )?
As such, the Food and Drug Administration has established a mechanism in Section 513 (g) of the Federal Food, Drug, and Cosmetic Act by which device manufacturers can obtain answers regarding how FDA would classify their device, thus determining the approval process.
What should be included in a 513 ( G ) application?
Medical device companies should submit a 513 (g) application in writing to the appropriate office and identify it as such. The application should contain a cover letter, a description of the device, a description of the indicated use of the device, any proposed labeling and marketing materials for the device.
Why do medical devices have to have a 513 ( G )?
Determining the least cumbersome mechanism to get a device approved may also be a reason for a device manufacturer to submit a 513 (g). Medical device companies should submit a 513 (g) application in writing to the appropriate office and identify it as such.
What does section 513 ( a ) of the FD & C Act do?
Section 513(a) of the FD&C Act (21 U.S.C. 360c(a)) establishes three classes of devices based on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness: class I (general controls), class II (special controls in addition to general