Get the free DETERMINATION OF SIGNIFICANT RISK DEVICE - beaumont
Show details
This policy establishes a procedure for evaluating the relative risk of investigational medical devices used in research at the Beaumont Health System, outlining responsibilities of the Human Investigation
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign determination of significant risk
Edit your determination of significant risk form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your determination of significant risk form via URL. You can also download, print, or export forms to your preferred cloud storage service.
How to edit determination of significant risk online
To use our professional PDF editor, follow these steps:
1
Set up an account. If you are a new user, click Start Free Trial and establish a profile.
2
Upload a document. Select Add New on your Dashboard and transfer a file into the system in one of the following ways: by uploading it from your device or importing from the cloud, web, or internal mail. Then, click Start editing.
3
Edit determination of significant risk. Rearrange and rotate pages, insert new and alter existing texts, add new objects, and take advantage of other helpful tools. Click Done to apply changes and return to your Dashboard. Go to the Documents tab to access merging, splitting, locking, or unlocking functions.
4
Get your file. Select the name of your file in the docs list and choose your preferred exporting method. You can download it as a PDF, save it in another format, send it by email, or transfer it to the cloud.
pdfFiller makes working with documents easier than you could ever imagine. Register for an account and see for yourself!
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out determination of significant risk
How to fill out DETERMINATION OF SIGNIFICANT RISK DEVICE
01
Obtain the DETERMINATION OF SIGNIFICANT RISK DEVICE form from the relevant regulatory agency.
02
Read the instructions carefully to understand the requirements.
03
Identify the device in question and gather all supporting documentation.
04
Fill out the identification section with the device name, manufacturer, and model number.
05
Assess and document the intended use of the device.
06
Evaluate the potential risks associated with the device and elaborate on the risk mitigation strategies.
07
Provide detailed information about clinical data or studies related to the device.
08
Review all completed sections for accuracy and completeness.
09
Sign and date the form as required before submission.
Who needs DETERMINATION OF SIGNIFICANT RISK DEVICE?
01
Manufacturers of medical devices intending to bring a new device to market.
02
Regulatory bodies that need to assess the risk of devices for compliance.
03
Healthcare providers evaluating the safety of devices for patient use.
04
Research institutions conducting studies involving medical devices.
Fill
form
: Try Risk Free
People Also Ask about
What is an NSR device?
Examples of NSR devices include most day-wear contact lenses and lens solutions, ultrasonic dental scalers, and foley catheters. SR devices must meet all regulatory requirements set in 21 CFR 812, including the requirement for approval by both IRB and the FDA before commencing the study.
What is IDE approval?
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.
What is the IDE policy?
IDE in the workplace refers to promoting a fair and equal working environment that respects and values the differences among employees, including those based on race, gender, age, ethnicity, sexual orientation, religion, and ability.
What is the risk determination of a device?
The risk determination is based on the proposed use of a device in an investigation, and not on the device alone. What is the nature of harm that may result from use of the device? SR studies are those that present a potential for serious risk to the health, safety, or welfare of a subject.
What does IDE stand for?
An integrated development environment (IDE) is a software application that helps programmers develop software code efficiently. It increases developer productivity by combining capabilities such as software editing, building, testing, and packaging in an easy-to-use application.
What does IDE stand for in trials?
An FDA-approved Investigational Device Exemption Application (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device (21 CFR 812.1).
How long does it take to get IDE approval?
Once the initial IDE submission has been sent to the FDA, a team of staff reviews the IDE and provides one of several standard responses within 30 days of receipt. For additional information, see FDA's Guidance document entitled FDA Decisions for Investigational Device Exemption Clinical Investigations.
What does ide approval mean?
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA.
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is DETERMINATION OF SIGNIFICANT RISK DEVICE?
DETERMINATION OF SIGNIFICANT RISK DEVICE is a regulatory document used to assess whether a medical device poses a significant risk to patients or users, guiding the classification and regulatory pathway.
Who is required to file DETERMINATION OF SIGNIFICANT RISK DEVICE?
Manufacturers or sponsors of medical devices are required to file the DETERMINATION OF SIGNIFICANT RISK DEVICE, especially when the device is involved in clinical studies.
How to fill out DETERMINATION OF SIGNIFICANT RISK DEVICE?
To fill out the DETERMINATION OF SIGNIFICANT RISK DEVICE, one must provide relevant details about the device, including its intended use, the population it serves, the potential risks, and any mitigating measures.
What is the purpose of DETERMINATION OF SIGNIFICANT RISK DEVICE?
The purpose of the DETERMINATION OF SIGNIFICANT RISK DEVICE is to evaluate and categorize the level of risk associated with a medical device to ensure appropriate regulatory oversight.
What information must be reported on DETERMINATION OF SIGNIFICANT RISK DEVICE?
The report must include details such as the device name, intended use, risk assessment, clinical study design, and any prior similar devices or studies.
Fill out your determination of significant risk online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
Determination Of Significant Risk is not the form you're looking for?Search for another form here.
Relevant keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
