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Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #K95-1) (Text Only)

510(k) Requirements During Firm-Initiated Recalls 

510(k) Memorandum #K95-1

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.

 November 21, 1995
 
 Director
 Office of Device Evaluation
 
 510(k) Requirements During Firm-Initiated Recalls
 
 ODE Review Staff
 Through:  ODE Branch Chiefs
  
 Purpose
 
 The purpose of this memorandum is to implement the procedures embodied 
 in the attached guidance for the Office of Compliance and the Office of 
 Device Evaluation concerning recall and premarket notification review 
 procedures during a firm-initiated recall of a legally marketed device. 

November 21, 1995
 
 Director
 Office of Device Evaluation
 
 510(k) Requirements During Firm-Initiated Recalls
  
 ODE Review Staff
 Through:  ODE Branch Chiefs
  
 Purpose
 
 The purpose of this memorandum is to implement the procedures embodied 
 in the attached guidance for the Office of Compliance and the Office of 
 Device Evaluation concerning recall and premarket notification review 
 procedures during a firm-initiated recall of a legally marketed device.  
 
 Background
 
 When a firm initiates a recall of a device, the firm's recall strategy 
 may include a proposal to modify the device to correct the cause of the 
 recall.  In the past, the Office of Compliance (OC) asked the Office of 
 Science and Technology to conduct a preliminary assessment of the 
 proposed correction.  If the correction appeared to be appropriate, the 
 Center exercised enforcement discretion and allowed the firm to 
 implement the correction for units of the device that were already 
 distributed.  If the modification was of a type that required a new 
 premarket notification, the firm generally had to submit a premarket 
 notification and obtain clearance from the Office of Device Evaluation 
 (ODE) before implementing the correction for any new production.  This 
 process involved redundant reviews and potentially conflicting 
 assessments of the same modification, and could unnecessarily delay 
 corrections of defective devices.  
 
 The document in Attachment A, entitled "Guidance on Recall and 
 Premarket Notification Review Procedures During Firm-initiated Recalls 
 of Legally Marketed Devices" was signed by the Directors of OC and ODE 
 on October 27, 1995.  It contains standard operating procedures that 
 are designed to eliminate redundancy in reviews and streamline the 
 overall process.  This guidance was developed by an ad hoc committee 
 within CDRH.  The guidance was the subject of review at two Center 
 "poststaff" meetings at which input and comments were received from all 
 Center offices, as well as meetings of OC's and ODE's senior staff.  In 
 addition, it has been discussed with several medical device trade 
 associations and has been the subject of public discussion.
 
 Procedures
 
 The new procedures that will be followed within OC and ODE are set 
 forth in the attached guidance.  A flow chart for these procedures, 
 entitled "510(k) Requirements for Proposed "Fixes" to Devices 
 Undergoing Recall," appears in Attachment B.  If you have any questions 
 concerning the application of these procedures to a specific situation 
 you may have, please contact the 510(k) Staff, ODE, for additional 
 guidance.
 
 Effective Date
 
 This memorandum is effective immediately.
 
 
 
                                   Susan Alpert, Ph.D., M.D. 

510(k) Memorandum - #K95-1
                                              Attachment A - Page 1
 

 October 27, 1995
 
 Guidance on Recall and Premarket Notification
 Review Procedures During Firm-Initiated
 Recalls of Legally Marketed Devices
  
 
 Applicability and Purpose
 
 This procedural guidance applies to recall actions in which a firm 
 notifies the Food and Drug Administration (FDA) that it intends to 
 modify a legally marketed device (as defined in 21 CFR 807.92(a)(3)) to 
 correct the cause of a recall.  If the correction proposed by the firm 
 will alter the device rather than just restore it to its original 
 specifications, there is a potential for redundant review of the 
 correction within the Center for Devices and Radiological Health (CDRH) 
 through both the recall process and the premarket notification (510(k)) 
 process.  The purpose of this guidance is to encourage timely 
 corrections of defective devices by clarifying which process CDRH will 
 use to review such modifications and by eliminating redundant 
 procedures in cases where both processes apply.  This document 
 supersedes guidance on this topic provided in a June 29, 1994 
 memorandum from the former director of CDRH's Office of Compliance (OC) 
 to OC staff.
 
 This guidance is not intended to apply to:  recall actions for devices 
 that were introduced to the market without proper premarket clearance; 
 corrections that FDA is informed of retrospectively rather than before 
 they are made; or situations that are not bona fide recalls.
 
 Approach
 
 The attached chart summarizes the decision process that CDRH will use 
 to determine whether the review of a proposed correction will be 
 conducted solely through the recall process or with the 510(k) process.  
 The basic intent is to avoid duplicative review of proposed device 
 corrections.  OC has overall responsibility within CDRH for 
 coordinating the recall decision process, while the Office of Device 
 Evaluation (ODE) is responsible for making certain decisions specified 
 in the attached chart.
 
 During a recall action, OC's case officer will review the firm's recall 
 strategy to determine if the firm's corrective actions include a 
 proposed modification to the device.  In making this determination, 
 OC's case officer will consider whether a correction alters the device 
 rather than just restoring it to its original specifications.  If the 
 correction just restores the device to its original specifications 
 (e.g., a correction involving good manufacturing practices), OC's case 
 officer will determine that the recall does not involve a modification 
 to the device.  In this case, no 510(k) issue is involved and OC's case 
 officer will process the recall accordingly.  On the other hand, if the 
 firm's recall strategy includes a correction that may alter the device, 
 OC's case officer will ask the appropriate ODE division to assess 
 whether the proposed modification requires a 510(k) submission.F
 CDRH is currently developing guidance on how to determine whether a 
 device modification requires a 510(k) submission.  When the guidance is 
 available, ODE will refer to it in making this decision.

 ODE will consider whether the modification could significantly affect 
 safety or effectiveness (per 21 CFR 807.81(a)(3)).  Because recalls 
 usually involve situations that present risks to health, modifications 
 intended to correct the cause of a recall usually will satisfy this 
 criterion.  Thus, corrections that alter the indications for use, 
 design, or performance specifications of a device usually will require 
 a 510(k) submission.  If, however, ODE determines that the modification 
 could not significantly affect safety or effectiveness, no 510(k) 
 submission will be required and OC's case officer will process the 
 recall accordingly.
 
 The following procedures will be used to assess a proposed correction 
 that requires a 510(k) submission.  In general, ODE will attempt to 
 assess the correction during the recall process, and will not repeat 
 this assessment when reviewing the 510(k) submission.
 
  ·    Special 510(k) -- Corrective Action Being Effected.  During 
       the recall process, ODE (with input from other offices, if 
       appropriate) will attempt to assess whether the modification 
       appears to be an adequate correction, and whether the 
       modified device will be "substantially equivalent."  This 
       approach is conditioned upon the firm providing sufficient 
       information to assess the proposed modification during the 
       recall process.  If ODE believes that the proposed 
       modification is appropriate, OC will inform the firm of this 
       assessment and will instruct the firm to submit a "Special 
       510(k) -- Corrective Action Being Effected."  ODE will 
       conduct only an abbreviated review of the 510(k), and will 
       strive to complete the review within 30 days.  The purpose of 
       the abbreviated review will be to ensure that the 510(k) 
       submission is administratively complete, and that it includes 
       only the modification(s) already found acceptable by CDRH as 
       part of the recall process.  While 510(k) clearance is 
       pending, CDRH will exercise enforcement discretion and allow 
       the firm to implement the modification (both retrofitting and 
       new production).
  
  ·    Traditional 510(k).  The above approach will not be used if 
       sufficient information to assess the modification is not readily 
       available from a firm during the recall process (such as when 
       extensive testing is needed).  In this case, OC will inform the 
       firm that review of the modification will be conducted through 
       the 510(k) process rather than the recall process, and that the 
       firm may not market the modified device (retrofitting or new 
       production) until 510(k) clearance is obtained.  If the firm 
       requests expedited 510(k) review because there is an urgent need 
       for the device, and ODE agrees that there is an urgent need, ODE 
       will expedite review of the 510(k) submission.  In the absence of 
       an urgent need, the 510(k) submission will be reviewed according 
       to the "first-in, first-reviewed" policy normally applicable to 
       510(k) submissions.
  
  Effective Date
  
  This guidance takes effect upon issuance.  Questions on the 
  interpretation of this guidance should be directed to Heather 
  Rosecrans, ODE, or John Samalik, OC.
  
  
       // s//          // s //
  
  Susan Alpert, Ph.D., M.D.          Lillian Gill
  Director, ODE                      Director, OC
 

510(k) Memorandum - #K95-1
                                 Attachment B - Page 1
  
 510(k) Requirements for Proposed "Fixes" to Devices Undergoing Recall