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In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions - Appendix H - Premarket Notification [510(K)] Checklist For Acceptance Decision

 IVD Manual Appendixes Index

APPENDIX H - PREMARKET NOTIFICATION [510(K)] CHECKLIST FOR ACCEPTANCE DECISION

Revised: 8-20-93

K ____________      Date DMC Received ____________

Device Trade Name: _____________________________________

Reason for 510(k) _____________________________________

Division/Branch: _____________________________________

Administrative Reviewer Signature: ____________________ Date ___________

Supervisory Signature ____________________ Date ____________________

Did the firm request expedited review? ____________________

Did we grant expedited review: ____________________

_______          _____________

accepted          refuse to
                        accept

 

  Yes
Present
Omission Justified		 Yes
Inadequate
Omitted

 

I.     Critical Elements:    
  1. Is the product a device?
 o o
  1. Is the device exempt from 510(k) by regulation or policy?
 o o
  1. Is device subject to review by CDRH?
 o o
  1. (I) Are you aware that this device has been the subject of a previous NSE decision?

    (ii) If yes, does this new 510(k) address the NSE issue(s) (e.g., performance data)?
 o o
  1. (I) Are you aware of the submitter being the subject of an integrity investigation?

    If yes, consult ODE Integrity Officer.
 o o
  1. Has the ODE Integrity Officer given permission to proceed with the review?
    (Blue Book Memo #I91-2 and Federal Register 90N-0332, September 10, 1991.)
 o o
Does the submission contain the information required under Sections 510(k), 513(f), and 513(I) of the Federal Food, Drug, and Cosmetic Act (the Act) and Subpart E of Part 807 in Title 21 of the Code of Federal Regulations?:
    
  1. Device trade or proprietary name
 o o
  1. Device common or usual name or classification name
 o o
  1. Establishment registration number (only applies if establishment is registered)
 o o
  1. Class into which the device is classified under (21 CFR Parts 862 to 982)
 o o
  1. Classification Panel
 o o
  1. Action taken to comply with Section 514 of the Act
 o o
  1. Proposed labels, labeling and advertisements (if available) that describe the device, its intended use, and directions for use (Blue Book Memo #G91-1)
 o o

  1. A 510(k) summary of safety and effectiveness or a 510(k) statement that safety and effectiveness information will be made available to any person upon request.
o
o

  1. For class III devices only, a class III certification and a class III summary
o
o

  1. Photographs of the device     
o
o

  1. Engineering drawings for the device with dimensions and tolerance
o
o

  1. The marketed device(s) to which equivalence is claimed including labeling and description of the device
o
o

  1. Statement of similarities and/or differences with marketed device(s)
o
o

  1. Data to show consequences and effects of a modified device(s)
o
o

III.     Additional Information that is necessary under 21 CFR 807.87(h):


  1. Submitter's name and address
o
o

  1. Contact person, telephone number and fax number
o
o

  1. Representative/Consultant if applicable
o
o

  1. Table of Contents with pagination
o
o

  1. Address of manufacturing facility/facilities and, if appropriate, sterilization site(s)
o
o

III.     Additional information that may be necessary under 21 CFR 807.87(h):


  1. Comparison table of the new device to the marketed device(s)
o
o

  1. Action taken to comply with voluntary standards
o
o

  1. Performance data:


  • marketed device:


  • bench testing
o
o

  • animal testing
o
o

  • clinical data
o
o

  • new device:


  • bench testing
o
o

  • animal testing
o
o

  • clinical data
o
o

  1. Sterilization information
o
o

  1. Software information
o
o

  1. Hardware information
o
o

  1. If this 510(k) is for a kit, has the kit certification statement been provided?
o
o

  1. Is this device subject to issues that have been addressed in specific guidance document(s)?
o
o

If yes, continue review with checklist from any appropriate guidance documents.
o
o

If no, is 510(k) sufficiently complete to allow substantive review?
o
o

  1. Other (specify)
o
o
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