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and cannot reasonably be expected in 30 days, the Division Director will sign the "major deficiencies/your 510(k) is withdrawn" letter.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