Cdrh premarket review cover sheet. Cover Class III Summary and Certification 8. Date of Submission SECTION A SECTION B ( If Yes please complete review Section I Page 5) Division Name ( if applicable) Phone Number ( including area code) Street Address FAX Number ( including cdrh area code) premarket City Contact. See OMB Statement on page 5. Cover Sheet Class III Summary premarket Certification Substantial Equivalence cover Discussion CDRH Premarket Review Submission Cover Sheet Financial Certification , Summary Reports 510 ( k) Cover Letter Device sheet Description Proposed premarket Labeling Indications for Use Statement Sterilization , Disclosure Statement Declarations of Conformity Shelf Life. Give a general description of the disease sheet condition that cover the device will diagnose, prevent, treat, , cure, mitigate include a description review of the patient population for cdrh which the device is intended. User Fee Cover Sheet ( review Form 3601) 2. If you submit your 510( k) directly to the FDA, you review must include sheet a sheet form 3601. Expiration Date: May 31,.
CDRH PREMARKET REVIEW SUBMISSION COVER SHEET Form Approval OMB No. CDRH Premarket premarket Review Submission Cover Sheet. FDA Submission Document Number ( if known) premarket Date of Submission 01126/ SECTION A PMA Original sheet Submission Premarket Report Modular Submission Amendment Report Report Amendment LjCensing Agreement IDE If this message is not eventually replaced review cdrh by the proper contents of the document, your PDF viewer may not be able to display cover this type of document. Submission Issue Meeting request) for CDRH submissions please clearly indicate that the submission cover is a Submission Issue Meeting request on the CDRH Premarket Review Submission Cover Sheet. Sections Required for a Traditional cdrh FDA 510( k) Submission The Traditional 510k submission is required for most new sheet products cdrh and therefore is the most common type of application.
The summary section must contain the following information: cdrh Indications for use. Financial Certification or Disclosure Statement 9. This is an optional form that is intended to provide the cover basic administrative premarket information about the device and the firm submitting the 510( k) submission. For applications cover sent through a 3rd Party such as review Intertek you may omit the form. Expiration Date: August 31,. Understanding sheet sheet FDA Regulatory Requirements cdrh for an Investigational Device Exemption ( IDE) for Sponsor- Investigators. Indications for Use ( Form 3881) – This must be identical to the Indications in review labeling , 510( k) Summary other cover cdrh documents.
CDRH Premarket premarket Review Submission Cover Sheet This is an sheet optional premarket form that is intended to provide the basic administrative information review cdrh premarket about the cdrh device and the firm review review submitting the 510( k) submission. a cover letter that clearly identifies the submission type in the sheet reference line ( i. cdrh premarket review submission cover sheet Saving the Adobe Approval , Emailing your data can only be done with the full version of the Adobe Acrobat , Retrieving not with the free Adobe Reader. premarket CDRH Premarket Review Submission Cover Sheet ( Form 3514) 3. Indications for Use Statement 5. The above mentioned document ( form 3514) has officially expired last August cover ( according to the validity date on the document found cover on forms. The sheet two- premarket page summary published on the FDA website is not review the complete 510k application cdrh that must be submitted to the FDA, but it is only a short summary to give general.
510( k) Summary or 510( k) Statement 6. Truthful and Accuracy Statement 7. Listing of all external Forms both OMB approved and state using ORA forms.
Persons using assistive technology might not be able to fully access information in this file. For assistance, please send e- mail to: gov. Type 508 Accommodation and the title of the report in the subject line of e- mail. Medical Device User Fee Cover Sheet ( Form FDA 3601) • CDRH Premarket Review Submission Cover Sheet • 510( k) Cover Letter • Indications for Use Statement • 510( k) Summary or 510( k) Statement • Truthful and Accuracy Statement • Class III Summary and Certification • Financial Certification or Disclosure Statement • Declarations of. FDA Guidance - 510 k Checklist - Download as PDF File (. pdf), Text File (.
cdrh premarket review cover sheet
txt) or read online. CDRH Premarket Review Submission Cover Sheet 510( k) Cover Letter. Medical Device User Fee Cover Sheet ( Form FDA 3601) 2.