Get the free CDRH SUBMISSION COVER SHEET - accessdata fda

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002 December 5, 2014, Cling

How to fill out cdrh submission cover sheet

How to fill out a CDRH submission cover sheet:

1. Start by providing your contact information on the cover sheet. Include your full name, company name (if applicable), address, phone number, and email address.
2. Indicate the submission type and select the appropriate submission number. Different types of submissions may include premarket notifications, premarket approval applications, and investigational device exemptions.
3. Include the title of the submission. This should be concise and accurately reflect the content of your submission.
4. Specify the medical device classification. This can be found by referring to the FDA's medical device databases or consulting relevant guidance documents.
5. Provide a brief abstract or summary of the submission. This should give a high-level overview of the content and purpose of your submission.
6. Include a list of all attachments or supporting documents that are submitted along with the cover sheet. Be sure to reference each attachment by title or document number.
7. Sign and date the cover sheet. This confirms that the information provided is accurate and complete.

Who needs a CDRH submission cover sheet?

1. Manufacturers or sponsors of medical devices who are submitting applications or notifications to the Center for Device and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).
2. Individuals or organizations seeking approval or clearance for a medical device to be marketed in the United States.
3. Any entity submitting amendments, supplements, or additional information related to a previously submitted application or notification.

Note: It is important to consult the FDA's guidance documents and regulations specific to your submission to ensure accurate completion of the CDRH submission cover sheet.

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What is cdrh submission cover sheet?

The cdrh submission cover sheet is a document that provides a summary of information about a medical device submission to the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA).

Who is required to file cdrh submission cover sheet?

The manufacturer or distributor of a medical device is required to file the cdrh submission cover sheet when submitting certain types of applications or notifications to the FDA.

How to fill out cdrh submission cover sheet?

To fill out the cdrh submission cover sheet, the applicant must provide information such as the device name, manufacturer information, regulatory submission type, and contact details.

What is the purpose of cdrh submission cover sheet?

The purpose of the cdrh submission cover sheet is to provide a quick overview of the submission to FDA reviewers and facilitate the review process for medical device applications.

What information must be reported on cdrh submission cover sheet?

Information that must be reported on the cdrh submission cover sheet includes device identification, submission type, applicant details, and information about the submission contents.