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the "major deficiencies/your 510(k) is withdrawn" letter.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
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