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U.S. Department of Health and Human Services

Medical Devices

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510(k) Sign-Off Procedures #K94-2 (blue book memo) (Text Only)

510(k) Memorandum #K94-2

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.

 

      June  1, 1994
     
     Acting Director             
     ODE, HFZ-400                 
     
     510(k) Sign-Off Procedures
     
     ODE Review Staff
     Through:  ODE Branch Chiefs
     
     
     Purpose
     
     This memorandum establishes new ODE sign-off procedures for 510(k) 
     final decision letters and requests for additional information.  It 
     rescinds and replaces Blue Book Memorandum "510(k) Memorandum #86-2 
     (Revised)".  
     
     Procedures
     
     Attachment 1 is a summary of the 510(k) sign-off procedures.  The 
     three attachments to this memorandum will be updated and distributed 
     periodically, as necessary.
     
    1.   Unable to Determine Substantial Equivalence Due to Deficiencies
    
         When additional information is necessary to complete a 510(k) 
         review and the reviewer can reasonably expect the information to 
         be submitted in 30 days from the requested date, the request for 
         additional information letter will be signed by the Branch Chief, 
         Associate Director or Division Director.  These signed letters 
         should be forwarded to the 510(k) DMC for dating and issuance.  If 
         the additional information requested is extensive, and cannot 
         reasonably be expected in 30 days, the Division Director will sign 
         the "major deficiencies/your 510(k) is withdrawn" letter.  These 
         signed letters should be forwarded to 510(k) DMC for dating and 
         issuance.  For detailed information about 510(k) additional 
         information procedures and what letter to use refer to Blue Book 
         Memorandum "510(k) Memorandum #K93-1.

    2.   Devices Exempt by Regulation from Premarket Notification
    
         Responses to premarket notifications received for devices that are 
         exempt by final regulation from premarket notification should be 
         approved by and bear the signature block of the Division Director.  
         Signed letters should then be forwarded to the 510(k) DMC for 
         dating and issuance.
         
    3.   "Standard" Substantial Equivalency (SE) Responses
    
         Responses to premarket notifications for devices that are 
         substantially equivalent and that do not require warnings 
         (including misbranding or adulteration), qualifications, 
         conditions (labeling restrictions), or involve another FDA 
         regulated program, e.g., drugs or biologics, or another federal 
         office (i.e., EPA, CPSC, DOE), or otherwise do not require a 
         unique response, should be approved by and bear the signature of 
         the Division Director.  Also, there are special routine letters 
         that are frequently used for a few specific devices within a 
         Division that should be signed by the Division Director.  For 
         example, a special routine letter is used for some orthopedic 
         implants that places limitations on the labeling for the device 
         (e.g., for use with bone cement only).  Prior to any use of such 
         specific routine letters, the language and the circumstances under 
         which they would be used must be discussed and agreed to on a 
         case-by-case basis between the Division Director, and the 510(k) 
         Staff and/or the POS Drug/Compliance coordinator.  A list of 
         specific routine letters approved to date that can be  signed by 
         the Division Director without discussions with the POS 510(k) 
         Staff or the POS Drug/Compliance coordinator is attached 
         (attachment 2).  Signed letters should then be forwarded by the 
         Division to the 510(k) DMC for dating, checking of the reference 
         list and class III GMP inspection program and issuance.
    
    4.   Conditional Substantial Equivalency Device Kits or Unique
         Responses (Includes devices with questions/issues regarding a 
         drug, biologic, other non-medical device or misbranding or 
         adulteration or a device requiring postmarket surveillance)

         Responses to premarket notifications that require unique 
         responses, for example, devices that have a drug or biologic, a 
         device requiring postmarket surveillance or other issue (including 
         determination of a general purpose article, organ/tissue transport 
         media, preamendments status, or non-device status) will be 
         prepared for the signature of the Division Director.  Such 
         premarket notifications must be discussed with and cleared by the 
         POS 510(k) Staff and/or Drug/Compliance Coordinator before the 
         final decision letter issues.  Signed letters should be forwarded 
         to the 510(k) DMC with the appropriate closeout code noted on the 
         review memorandum (see attachment 3) for dating and issuance.
    
    5.   Not Substantially Equivalent/Unable to Determine Responses
    
         Responses to premarket notifications for devices that are found to 
         be not substantially equivalent (NSE) are to be prepared for the 
         signature of the Division Director.  Such premarket notifications 
         should be discussed and cleared by the POS 510(k) Staff before the 
         final decision letter issues.  Signed letters should be forwarded 
         to the 510(k) DMC for dating and issuance (no reference list or 
         class III/GMP needed).
    
    6.   Devices with New Technological Characteristics
    
         Decisions on devices that have new technological characteristics 
         that have not been previously found substantially equivalent must 
         be discussed with the POS 510(k) Staff at the earliest opportunity 
         and certainly before preparing any correspondence.  Correspondence 
         for such devices will be prepared for the signature of the 
         Division Director.
    
    7.   Other Decisions or Correspondence After a Final Decision
    
         All other decisions or correspondence after issuance of a final 
         decision (SE, NSE, Exempt, and etc.) will not be prepared before 
         they are discussed with the POS 510(k) Staff.  These decisions 
         will include, but are not limited to, responses to an appeal of a 
         decision, recission of a decision or clarification of a decision.  
         These letters will be prepared for and bear the signature of the 
         Deputy Director of ODE.  These letters should be forwarded to the 
         POS 510(k) Staff for processing out.
    
    Effective Date:  This memorandum is effective immediately.
    
    
    
    
    
                                   Susan Alpert, Ph.D., M.D.
    
    Attachments

Attachment 1  (June 1, 1994)


                        Summary of Premarket Notification
                        Sign-Off and Processing Procedures
                         
                                                 POS Discussion/    	Division
                                                 Clearance Drug/    Forward
     Decision Type                 Approved By   Compliance Coord.  Letter To
     
  I.  Unable to Determine          
      Substantial Equivalence/
      Request for Additional
      Information Response

      a. can be responded to
         in 30 days or less        Branch Chief        No          510(k) DMC

      b. cannot be reponded to     Division
         in 30 days or less        Director            No          510(k) DMC

 II.  Device Exempt by regulation
      from premarket notification  Division
      Response                     Director            No          510(k) DMC

III.  "Standard" Substantial       Division
      Equivalency Responses        Director            No          510(k) DMC

 IV.  "Conditional" Substantial
      Equivalency or Unique        Division
      Response                     Director            Yes         POS 510(k)
                                                                   DMC

  V.  Not Substantially            Division
      Equivalent Responses         Director            Yes         POS 510(k)
                                                                   DMC

 VI.  Devices with New
      Technological                Division
      Characteristics              Director            Yes         POS 510(k)
                                                                   DMC

VII.  All letters after
      insurance of any final  
      decision (SE, NSE,           Deputy
      exempt, etc.)                Director            Yes         POS 510(k)
                                                                   Staff

Attachment 2 (June 1, 1994) 
     
     
                   Routine Letters Signed by ODE Division Directors
     
     
     DCLD -    None
     
     DCRND -   None
     
     DOD -     None
     
     DRAERD -  1) In vitro Fertilization Disclaimer
               2) Ultrasound/Transducer Model Letter
     
     DGRD -    1) Orthopedic Implants with Bone Cement
               2) Wound Dressings
               3) Surgical Gloves - Dusting Powder
               4) Lasers - Electronic Language
               5) Cannulas and Aspirators - Suction Lipectomy

Attachment 3 (June 1, 1994)
                                510(k) DECISION CODES
     
     
  Signature Block        Substantially Equivalent Codes
     
         DD - SP    Substantially Equivalent - Postmarket Surveillance-5/92
         DD - KD    Substantially Equivalent - Kit with Drugs-8/89
         DD - RN    Substantially Equivalent - Rescind Non-Substantial Equivalence-8/89
         DD - SD    Substantially Equivalent with Drug
         DD - SE    Substantially Equivalent
         DD - SK    Substantially Equivalent - Kit-8/89
         DD - SL    Substantially Equivalent - Improper Label
         DD - SN    Substantially Equivalent for Some Indications
         DD - SW    Substantially Equivalent waiting on a drug-11/90
         DD - SI    Substantially Equivalent waiting on inspection
         DD - SA    Substantially Equivalent waiting on a device-12/91
         DD - PR    Proposed Rescission
         DD - SF    Substantially Equivalent waiting on future policies
         DD - SO    Substantially Equivalent - not subject to CLIA categorization
         DD - SX    Substantially Equivalent - CLIA categorization waived
         DD - SM    Substantially Equivalent - moderate CLIA category
         DD - SH    Substantially Equivalent - high CLIA category
         DD - ST    Substantially Equivalent - Tracking Regulation
         DD - PT    Substantially Equivalent - Post Market Surveillance - Tracking Regulation

                             Non-Substantially Equivalent Codes
     
         DD - NE    Not Substantially Equivalent
         PJP - RE   Rescind Substantial Equivalence
               UD   Unable to Determine Equivalence - no longer used after 9/30/87
         DD - SC    Pre-amendment Investigational - Cannot Market (prior to 7-1-91
                    counted as an "SE")
         DD - UO    Unable to Determine Equivalence - Outstanding Drug Issue
         DD - OD    Outstanding Device - Unable to Determine Equivalence
         DD - SL    Substantially Equivalent - Improper Label (5-12-92)
         DD - UR    Unreliable Data (Fraud Policy)-5/92
         DD - FB    515(B) Requires PMA
         DD - DA    Did not Answer
                         
                         Other Decision Codes
     
         DD - DB    Forwarded to Drugs/Biologics (letter 1/91)
         MS - DD    Deleted/Duplicate
         MS - DE    Deleted
         DD - EX    Exempted by Regulation
         DD - GP    General Purpose Article-7/89
         DD - K4    Closeout Letter Issued
         DD - ND    Not a Device
         DD - NF    Not a Finished-7/89
         DD - NA    Not Actively Regulated-7/89
         DD - TR    Transitional Device
         MS - WD    Withdrawn by Applicant
         DD - NR    Not Required
              HO    Codes no longer used; once used to
              SP    Indicate "On Hold" or "Supplement Received"
         DD - DR    Drug due to Intercenter Agreement-3/92
         DD - PE    Preamendment Exempt-6/92
         DD - CR    Can't Respond within 30 days
         DD - RC    Reconditioners/Rebuilders-11/93
     
     Legend
     
     PJP - Deputy Director, ODE (Philip J. Phillips, Acting)
     MS -  Supervisor, Document Mail Center (Marjorie Shulman)
     DD -  Division Director, OD