Home
Forms Library
AND EFFECTIVENESS - accessdata fda

AND EFFECTIVENESS - accessdata fda 2025

AND EFFECTIVENESS - accessdata fda Preview on Page 1

Show details

4.5 out of 5

50 votes

The document is a 510(k) summary for the Cedars-Sinai Cardiac Suite, a software application intended for automated display, review, and quantification of Nuclear Medicine Cardiology images. It outlines the device's intended use, description, predicate devices, testing results, and regulatory compliance. The suite is designed for use in various medical settings and requires review by qualified healthcare professionals. The FDA has determined that the device is substantially equivalent to previously cleared devices.

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

The best way to modify AND EFFECTIVENESS - accessdata fda in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Adjusting documents with our comprehensive and intuitive PDF editor is simple. Make the steps below to complete AND EFFECTIVENESS - accessdata fda online easily and quickly:

Sign in to your account. Sign up with your credentials or create a free account to test the product before upgrading the subscription.
Import a form. Drag and drop the file from your device or import it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit AND EFFECTIVENESS - accessdata fda. Quickly add and underline text, insert images, checkmarks, and icons, drop new fillable areas, and rearrange or delete pages from your document.
Get the AND EFFECTIVENESS - accessdata fda completed. Download your modified document, export it to the cloud, print it from the editor, or share it with others via a Shareable link or as an email attachment.

Make the most of DocHub, one of the most easy-to-use editors to quickly handle your documentation online!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is substantial evidence FDA?

Substantial evidence means evidence consisting of one or more adequate and well-controlled studies, such as a study in a target species, study in laboratory animals, field study, bioequivalence study, or an in vitro study, on the basis of which it could fairly and reasonably be concluded by experts qualified by

How does FDA define efficacy?

Efficacy refers to how well a therapy provides the expected therapeutic effect on a disease or symptom under ideal and controlled circumstances. Phase 1 to 3 clinical trials are efficacy trials in the vast majority of cases.

What is the FDA integrated summary of efficacy?

The ISE is a comprehensive integrated analysis of the effectiveness of a study drug. The purpose of the ISE is to describe the available information regarding effectiveness, delineate strengths and weaknesses, and highlight important missing information.

How does FDA define effectiveness?

Under FDAMA, the definition of substantial evidence of effectiveness was amended to include a single adequate and well-controlled study and confirmatory evidence, if the Agency determines, based on relevant science, that the data establish effectiveness.

How does the FDA define substantial evidence of efficacy?

which included a provision requiring manufacturers of drug products to establish a drugs effectiveness by substantial evidence. Substantial evidence was defined in section 505(d) of the Act as evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified

What is the minimum efficacy suggested for FDA approval?

Under U.S. law, there is no particular level of efficacy required for a new drug to be approved.

What does the FDA requirements for efficacy need to be established based upon?

the drug is free of life-threatening side effects. FDA requirements for efficacy need to be established based upon randomized controlled trials for all of the following types of products, except: dietary supplements.

AND EFFECTIVENESS - accessdata fda 2025

Here's how it works