This message was posted by a user wishing to remain anonymous Regardless of whether your clinical trial has any participants, IF it's been submitted to your IND it may be a good idea include it under read more
The way an FDA auditor explained this to me was labels for uncleared/approved by FDA may not interfere with the health choices of any patient, either perceived or real possible treatment. If a patient read more
Forgot to mention the additional insights given by section 201(n) of the Act. It (my paraphrase) says that, if an article is alleged to be misbranded because the labeling or advertising is misleading, read more
The ANON reply was correct, CMC is required to be submitted outside the annual report. Please see this link: IND Application Reporting: Annual Reports | FDA Here is the required info in the IND annual read more
The validated range needs to allow for OOS (out of spec) findings. As a result, the validated range must be able to accurately test not only the range intended by the specification chosen, but the validated read more
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Medical device manufacturers must follow labelling requirements and appropriate labelling must be done on all Medical Devices before placing them in Indian Market. Rule 109A of Medical Device Rules, 2017 gives instructions for labelling of Medical Devices ...
This message was posted by a user wishing to remain anonymous Hello, I am working the Technical File for a Procedure Pack in the UK. Does anyone have guidance on the following: Due to the extension of the legislation, are all components in the procedure ...
This message was posted by a user wishing to remain anonymous Hi Everyone, Our company is trying to import a device into India. It is a class 1 Device in EU and FDA. We are based in UK and have design control and all product liability, but the device ...
This message was posted by a user wishing to remain anonymous Dear reg specialists, I am seeking your advice on the following. Are there any environmental requirements that IVDs manufacturer needs to be aware of for the disposal of clinical products? ...
This past summer, Korea issued article 43-6 of the Medical Device Act, requiring medical device manufacturers and importers to obtain liability insurance for patient claims of injury or death. For now, only manufacturers or importers of implantable device ...
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