Do you have strict requirements for quality and safety, with equally strict procedures required for meeting them? Is your industry regulated by the U.S. Food and Drug Administration (FDA)? FDA software validation is one way to ensure the tools you use when creating or distributing products are...
A meeting of FDA’s Patient Engagement Advisory Committee in July 2022 provided an opportunity for the agency to hear from experts and researchers in the field of extended reality and its uses, as well as companies developing medical extended reality devices and patients who have experienced such ...
You may also request aQ-Submission Meeting(Q Sub) with FDA to clarify regulatory requirements, get advice on what technical documentation to include, or discuss clinical studies needed to support your submission. These short meetings (in person, via phone, or in writing) allow you to ask a fe...
within-lab precision, carryover and cross contamination, and competitive inhibition. Previously, the EUA template only required these studies for Multiplex Respiratory panels in which a new instrument was used with the proposed device; however this De Novo was for a simple point-of-care device ...
FDA US agents have no certification process, but you should have a formal signed agreement or contract with your agent. I have never seen the FDA request a copy of the contract or a letter from a US agent or the company that is registered. However, since the agent has a legal role and...
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submission meeting request to the FDA. The FDA will respond within 75-90 days from your submission. If you are still developing your device and you have not started any performance testing, then this option may be your best approach. I recently recorded awebinar on pre-submission meeting ...
request formal dispute resolution. The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order. A proposed order or an interim order is not an appropriate subject for an FDR. Additionally, meeting minutes and...
FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed. RECOMMENDATION: Patients should discuss the benefits and risks of epidural corticosteroid injections ...
including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized. FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits...