The FDA Issued 

WARNING LETTERS

 

citing DESIGN CONTROL Inadequacies

FYI - The law requires that manufacturers of medical devices adhere to the Quality System Regulation

The grace period is over! The FDA has issued Warning Letters to Medical Device Companies citing noncompliance to Design Controls. The following chart details the text in the Warning Letters relating to Design Controls. They also cited 2 manufacturers for not having performed a Risk Analysis.

Warning Letter Date Warning Letter ID Location Device / Biologic Product
4/26/2000 00-NWJ-32 Millburn, New Jersey, USA Device Sterile Pericardial Patch
Warning Letter Excerpts
  • The Uropatch is a modification of the Pericardial patch. Design controls for the Uropatch are lacking with regard to the following: Design history file; Design plan; Design inputs; Design outputs; Design review, Design verification and Design validation.

  • With regard to the Design Controls submitted for the Uropatch modification, your response includes criteria for processing rather than actual device design and performance. For example, your response does not include inputs or outputs that address the performance requirements or the needs of the user and patient. The design outputs do not include acceptance criteria or identification of elements that are essential for the proper function of the device. There is no documentation or review and approval of design outputs. Also, there are no design reviews. The design verification statements concern tissue fixation and sterilization, but do not address the intended use of the device. There is no data for either fixation or sterilization. The design validation does not include data to show that the device performs as intended under defined operating conditions on initial production lots or their equivalents. The design validation does not ensure that the device will conform to defined user needs and intended uses. There are no documented results of design validation that identifies the methods, date and individuals performing the validation

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
4/18/2000 MIN 00-29 White Bear Lake, Minnesota, USA Device Amplatz Thrombectomy Device
Warning Letter Excerpts
  • Failure to perform design validation under defined operating conditions on initial production units, lots, or batches, or their equivalents [21 CFR -820.30(g); form FDA-483 item 2].

  • Failure to review, update, and approve plans as design and development evolves [21 CFR 820.30(b); form FDA-483 items 1 and 3].

  • We received your letter dated March 28, 2000, responding to the form FDA-483 issued on March 14, 2000. Although the response promises correction of the items referenced in the form FDA-483, it does not adequately address all our concerns. You have not justified that design validation results are valid for the production units.

 

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
4/4/2000 N/A Taunton, England Device Sterile, Implantable Medical Devices
Warning Letter Excerpts

21 CFR 820.30(c)

  • Failure to have procedures with a mechanism for addressing incomplete, ambiguous, or conflicting design requirements, and to have input requirements reviewed and approved by a designated individual, as required by 21 CFR 820.30(c). For example, neither [your] quality manual or ‘Procedure for the Design and Development of Products" documents the methods to be used for addressing incomplete, ambiguous or conflicting design requirements. Furthermore, even though the firm’s procedures stated that design input would be reviewed/approved, the signature page for the suction clearance kit failed to provide objective evidence of same since it was not signed.

Your response indicates that [you] propose changes to its Quality Manual and several DMR documents for establishing a mechanism to address incomplete, ambiguous, or conflicting design input requirements. With regard to review and approval of input requirements by a designated individual, [you] advises that the lack of signature on the suction kit documentation was due to the fact that the designated individual was out of the country at the time. The kit design input requirements were to be reviewed by the Managing Director. It is indicated that a designee will be responsible if the Managing Director is absent in the future. Again, it will be necessary for us to have copies of the completed procedures in order to determine whether they are adequate to meet the requirements of the QS regulation.

21 CFR 820.30(i)

  • Failure to establish and maintain design change procedures, as required by 21 CFR 820.30(i). For example, [you] could not provide objective evidence that a dimensional change to their Mills Incus Sleeve device had ever been verified to confirm that the pre-firing dimension would, in fact, result in the desired post-firing dimension, taking into consideration that HA shrinks when heated. Also, it was determined that [you] does not have documented procedures for the control of pre-production design changes.

[Your] response indicates that you have revised your design change proposal to include a procedure to verify that design output meets design input. Your letter acknowledges the failure to verify the dimensional change and states that you have "raised" your internal nonconformance. It is not clear what is meant by this statement. We understand that a procedure for controlling pre-production design changes would be established by April 30, 2000, at which time we would appreciate receiving a copy for review.

Should you have questions as to whether an additional 510(k) is required for this change, your inquiry should be directed to the Division of Ophthalmic and ENT Devices, Office of Device Evaluation, 9200 Corporate Boulevard, Rockville, Maryland 20850. You may also wish to access a copy of our guidance document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device."

21 CFR 820.30(g)

  • Failure to have adequate design validation procedures, as required by 21 CFR 820.30(g). For example, [your] quality manual refers to levels of acceptability in their section 4.4.8 "Design Validation. " The procedure fails to document how "levels of acceptability" are determined or how the risks are calculated. Furthermore, [your] design validation procedure does not specify that design validation be performed on initial production units, lots, or their equivalents, also required by 820.30(g). 

Your response indicates that [you] will be revising their procedures for risk analysis and to ensure that design validation is only performed on inhial production units, lots or their equivalents. Copies of these procedures need to be provided to FDA for review.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
4/3/2000 00-NWJ-28 Sewell, New Jersey, USA Device Scooters and Power Chairs
Warning Letter Excerpts
  • Your firm failed to establish and maintain procedures for the design of your electric scooters and power chairs in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).

  • Your design procedures for your Cavalier line of scooters (3 wheel, 4 wheel, and 4 wheel-short), which are contract manufactured by [xxx] do not contain the necessary elements of 21 CFR 820.30. For example:

    • There were no procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements, as required by 21 CFR 820.30(d).

    • There were no procedures to ensure that formal documented design reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e).

    • There were no procedures for verifying the device design, as required by 21 CFR 820.30(f).

    • There were no procedures for validating the device design, as required by21 CFR 820.30(g).

    • There were no procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h).

    • There were no procedures for the identification, documentation, validation or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

  • Your firm failed to establish a design history file for each type of device, as required by 21 CFR 820.30(j).

  • Your firm failed to establish and maintain procedures for verifying and validating the design for your Economy line of scooters, as required by 21 CFR 820.30(f).

  • Your firm failed to establish and maintain procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(j). Specifically, the investigator noted that changes to your [xxx] used in several of your power chairs, was not verified and/or validated.

The agency is in receipt of your written response, dated February 29,2000, to the FDA 483 issued to your firm on February 17,2000. We acknowledge your firm’s commitment to the Quality System Regulations; however, we have some comments to offer concerning your response. The procedures that you supplied were in "Preliminary Form." Have they been approved? Your response for #6 indicates that you feel [xxx] responsible for design controls. As an initial importer and holder of the specifications for the electric scooter, your firm is responsible for design controls. The procedure you provided for design controls will be need to be more detailed when a project actually begins. Please refer to 21 CFR 820.30 for guidance on what needs to be included in a design control procedure.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
3/9/2000 MIN 00-24 St. Anthony, Minnesota, USA Device Interferential Nerve and Muscle Stimulator
Warning Letter Excerpt
  • Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation [21 CFR 820.30(i)...].

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
2/25/2000 None Tuebingen, Germany Device Electrosurical Systems
Warning Letter Excerpts
  • Failure" to define responsibility" for implementation of design activities and identify and describe the interfaces with other groups or activities in the design plan, as required by 21 CFR 820.30(b). For example, the design plan entitled "Zeitplanung" for the modified ICC-300/350 software version 4.0 does not define responsibility of implementation or identify and describe interfaces with appropriate groups or activities, given in the Pflichtenheft for ICC Version V4.00.

  • Failure to establish design input procedures that include a mechanism for addressing incomplete, ambiguous, or conflicting requirements, as required by 21 CFR 820.30(c). For example, the design input procedures entitled "Verfahrensanweisung" lacked requirements for addressing incomplete ambiguous, or conflicting requirements (document VA-2204, version 001).

  • Failure of the design verification procedures to include or reference certain items needed and to resolve discrepancies in order to assure that design outputs meet design inputs, as required by 21 CFR 820.30(f). For example:

    • the combined design verification and validation document, "Inhaltsangabe," dated February 8, 1999, did not include or reference the following: (i) the test methods, (ii) acceptance criteria and tolerances for the maximum power output and peak voltage at no load, (iii) actual readings or theoretical calculations of the power output at each power setting above … watts when the pulse-modulated frequency starts changing, and (iv) actual readings of other high voltage measurements that would assure the Forced 4 Coagulation would reach a peak voltage of … volts at no load.

    • the design verification and validation document, "nhaltsangabe," had ICC 300 and 350 actual test results of the maximum power output and peak voltage at a no load condition different from those listed in the operator’s manuals, neither set of values including tolerances, and no evaluation or resolution of the discrepancies.

  • Failure to document risk analysis performed as a part of design validation activities, as required by 21 CFR 820.30(g). For example, a hospital used a prototype ICC 300/350 unit with software version 4.0 but no formal risk analysis and evaluation of the new software version were compiled.

  • Failure to conduct and document complete design validation activities, as required by 21 CFR 820.30(g). For example, the software validation for software version 4.0 used to control the modified ICC 300/350 may not have been conducted completely and results have not been formally documented.

  • Failure of the design control procedures to have the design transfer adequately reviewed to assure design specifications were correctly transferred to production specifications, as required by 21 CFR 820.30(h). For example, the design verification document does not define a specification range of the maximum power output for verification against production values.

  • Failure to include in design reviews an individual who does not have direct responsibility for design activities, as required by 21 CFR 820.30(e). For example, the design team identified in the project committee did not include an individual who does not have direct responsibility (document VA-2205, Version 003). 

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
02/22/2000 W/L 29-00 Wilmington, California, USA Device Reusable Sharps Containers
Warning Letter Excerpt
  • Failure to establish and implement procedures to control the design of your device in order to ensure that specified design requirements are met [21 CFR 820.30(a)]. 

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
2/7/2000 2000-DAL-WL-04 Abbott Park, Illinois, USA Device Clinical Chemistry Analyzers
Warning Letter Excerpts
  • Failure to establish and maintain procedures to ensure the design requirements relating to the Alcyon software are appropriate and address the intended use including user needs [21 CFR 820.30(c)]. Specifically, neither the ADD Software Development Requirements nor the Product Version Description Document (PVDD) for the Alcyon software version 1.5 make reference to any boundary condition(s) such as minimum, maximum or normal number of tests the Alcyon device is designed to perform within a given time period. Additionally, the PVDD for software version 1.7 contains no documentation showing that user needs have been addressed in the current software revision 1.5 or the next software version (1.8) as evidenced by over [xxx] open enhancement system problem reports.

  • Failure to establish and maintain procedures that verify and document that the design output conforms to design input requirements and that the design outputs were documented, reviewed and approved prior to release [21 CFR 820.30 (f)]. Specifically, 

    • The Verification and Validation Test Protocol [xxx] used in the testing of software versions 1.6 and 1.7, did not define the number of repetitions to be used in the performance of the stress test, the boundary conditions for volume and load, and the criteria used to accept the test results.

    • The PVDD Version 1, Alcyon rev 1.5 showed over [xxx] open System Problem Reports (SPRS) at the time of its release in November 1998.

    • The PVDD, Version 2, Alcyon rev.1.0 for software version 1.7 showed open SPRS which had been identified as software problems during the testing of versions 1.0 through 1.5, e.g. DAL [xxx] and DAL [xxx].

  • Failure to establish and maintain procedures for the documentation, verification, review and approval of design changes before their implementation [21 CFR 820.30(i)]. For example, 

    • Engineering Change Process procedure No. DA-04, Rev. K, dated 6/28/99, used for post-production changes did not have provisions for addressing pre-production change control and risk analysis. ..

    • ECN [xxx] dated 10/1 2/99, Software version 1.5, which was under development, was used in design verification and validation when the protocol specified that version 1.02 was to be used. There was no documented protocol approval of this design change prior to its implementation.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
1/6/2000 FLA-00-19 Port Orange, Florida, USA Device Reprocessing of Medical Devices
Warning Letter Excerpt
  • Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before implementation as required by 21 CFR 820.30(i). For example, design changes to labels and packaging of reprocessed devices, and to a pin involving [xxx] scalpel’s made in response to a consumer complaint, were not followed ...

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
1/5/2000 CHI-6-00 Lyons, Illinois, USA Device Intraocular Fluid
Warning Letter Excerpt
 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
12/9/1999 N/A Rodby, Denmark Device Syringes
Warning Letter Excerpts
  • Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development as required by 21 CFR 820.30(e). For example, the Design Control / Change Control procedures do not include procedures for design reviews.

  • Failure to establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements, as required by 21 CFR 820.30(d). For example, the Design Control / Change Control procedures do not include procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements.

  • Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). For example, procedures for verifying design outputs meet design inputs were not established.

  • Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example, the Design Control / Change Control procedures do not include procedures for validating the device design

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
12/9/1999 Cin-WL-00-16-0 Mentor, Ohio, USA Device Liquid Chemical Sterilizer and Associated Accessories, Quick Connect Kits and Processing Trays; Biological Monitoring Kit
Warning Letter Excerpts
  • Failure to establish and maintain procedures for validating the device design for Quick Connect Kits under defined operating conditions on initial production units, lots, or batches, or their equivalents and failure to ensure that devices conform to defined user needs and intended uses and that the testing of production units include testing under actual or simulated use conditions, as required by 21 CFR 820.30(g). …

    • Additionally, there is no documented evidence that testing one Quick Connect Kit with one particular type of scope assures that the tested Quick Connect Kit can be used with all of the types of scopes in that family. The studies to "validate" the Quick Connect Kits show that the flow of sterilant through the lumens is unaffected. The test is conducted three consecutive times and the Quick Connect Kit is approved for use with that particular scope on which it was tested and any model that falls within that scope-family line.

    • This appears to be a type of design verification rather than validation. Design validation goes beyond the technical issues of verifying that the design input meets the design output. It is intended to ensure that the product meets user requirements, the operating instructions, and any restrictions on the use of the product.

  • Failure to establish and maintain procedures for verifying the device design, i.e., that the design verification confirms that the design output meets the design input requirements, as required by 21 CFR 820.30(f).

    • For example, your firm did not have sufficient evidence in its design documentation to demonstrate that all models of endoscopes approved for use with a particular Quick Connect Kit could be adequately processed in the … System 1. Also there is no mechanism in your design control procedures for addressing and comparing design inputs to design outputs.

  • Failure to establish and maintain procedures for the identification, documentation, and validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, after release of a newly designed Quick Connect Kit, there is no mechanism to assure that design changes made to endoscopes do not impact the sterilization, the performance of the Quick Connect Kit, and any additional previous validation results.

  • Failure to establish and maintain a design history file for each type of device which contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements.

  • Failure to establish and maintain procedures which include a mechanism for addressing incomplete, ambiguous or conflicting device requirements, as required in21 CFR 820.30(c).

    • For example, the design input procedures for the Quick Connect Kits lacked a mechanism for addressing incomplete, ambiguous or conflicting requirements.

  • Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e).

    • The design procedures covering design review for the Quick Connect Kits are incomplete, in that a) appropriate stages of review are not identified. For example, the design review is only conducted at the end of the design process just prior to release to manufacturing; b) The Standard Operating Procedures do not ensure comprehensive and systematic design review.

  • Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation as required by 21 CFR 820.30(b).

    • For example, there is no design plan for the Quick Connect Kits. According to the Investigators’ report, the Test Contract, written for each Kit developed, is used as a plan to develop and test the kits. The Test Contract is inadequate in that it does not contain sufficient information to be considered a design plan.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
11/22/1999 None Rockville, Maryland, USA Device

Human Immunodeficiency Virus (HIV) 1/2 Gold Spot Test Kits and HIV 1/2 Rapid ELISA Assay Test Kits

Warning Letter Excerpt
  • Failure to conduct design validation on finished HIV test kits, in that a l-year expiration date is listed for the kits and no stability data is documented.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
10/13/1999 00-ATL-3 Lawrenceville, Georgia, USA Device Phototherapy Chambers
Warning Letter Excerpt
  • You have failed to establish and maintain procedures for the identification, documentation, validation or where appropriate, verification, review, and approval of design changes before their implementation. This is to assure that any proposed changes or modification to the original design of the device will be implemented in a manner to assure that the impact of the change will be fully evaluated and documented.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
3/24/1999 DEN-99-06 Englewood, Colorado, USA Device Sterile Disposable Surgical Instruments
Warning Letter Excerpts
  • Failure to establish and maintain procedures to control the design of the device  in order to ensure that specifies design requirements are met, as required by 21 CFR 820.30 (a)

  • Failure to establish and maintain procedures for the identification, documentation, and validation or where appropriate verification, review, and approval of design changes before their implementation.  For Example, changes to the product design for [XXX] were not documented during the time frame of September 1, 1998 through October 7, 1998.  Review and approval of design changes made to the [XXX]  were not recorded and the corresponding bill of materials for these changes for these changes was not updated in the computer system.

  • There is no design change procedure, which identifies when and how design changes will be reviewed and approved before implementation.   Validation and/or verification, which may result from design changes, are not addressed.

  • Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient.  For example: the "[XXX]" procedure does not clearly define design requirements, nor does it address what factors will cause inputs to be updated.  Also, the following relevant aspects were not addressed: Intended use, risk analysis, and design history files.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
3/22/1999 NWE-14-99W Burlington, Massachusetts, USA Device Stereotactic Radiosurgery Systems
Warning Letter Excerpts
  • Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, that appropriate representatives are included, and that the results of a design review, including identification of the design, the date, and the individual(s) performing the verification, are documented in the design history file as required by CFR 820.30(e). For example:

    • Procedures were not established to ensure that formal and systematic design reviews were conducted for the [xxx] software change. While design reviews were allegedly conducted, the results of those reviews, including identification of the design, the date, and individuals performing the review were not documented.

    • There is no documentation to show that the results of in-house verification testing underwent a design review prior to transfer of the design to production.

  • Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate, verification, review and approval of design changes before their implementation as required by 21 CFR 820.30(i). The Design Control Changes Procedure, QS3-04-0006 Rev. A (approved 3/6/97) lacks necessary detail in many areas:

  • Failure to establish and maintain design input procedures that ensure that design requirements relating to the device are appropriate, address intended use of the device, and the needs of the user and patient; failure to include a mechanism for addressing incomplete, ambiguous, or conflicting design requirements, as required by 21 CFR 820.30(c).

    • Design input procedures were not established for the [xxx] software change and there was no documented mechanism for addressing incomplete, ambiguous, or conflicting design requirements.

  • Failure to establish and maintain procedures for validating the device design; failure to document the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation in the design history file, as required by 21 CFR 820.30(g).

  • Failure to establish and maintain procedures for verifying the device design, to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). For example:

    • The results of testing show that the design / system requirements were not met for [xxx] procedures on page 5 & 8, the [xxx] procedure on page 20, and the [xxx] procedure on page 22 of the test plan. There is no documented justification for accepting the design with these discrepancies left unresolved.

  • Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications as required by 21 CFR 820.30(h). There was no established procedure …

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
3/9/1999 MIN-99-21 St. Paul, Minnesota, USA Device Penile Tumescence Monitor
Warning Letter Excerpts
  • Failure to establish and maintain procedures for the identification, documentation, validation, or appropriate verification, review and approval of design changes before their implementation as required by 21 CFR 820.30(i) in that there is no data to show that the [xxx] was validated or verified.

  • Failure to establish and maintain procedures for implementing corrective and preventative action [21 CFR 820.100] in that the firm lacks procedures to control the design process.

  • Failure to establish and maintain procedures for acceptance activities [21 CFR 820.80(c)] in that there is no documentation that test results used in the acceptance of in-process product have been verified against the approved specifications.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
3/3/1999 MIN-99-18 Minnetonka, Minnesota, USA Device Glucose Test Strips and Meters
Warning Letter Excerpts
  • Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation as required by 21 CFR 820.30(b)

  • Failure to ensure that the design input requirements are appropriate to assure that the device will perform to meet its intended use and the needs of the user as required by 21 CFR 820.30(c)

  • Failure to establish and maintain procedures defining and documenting design output in terms that allow adequate evaluation of conformance to design input requirements as required by 21CFR 8200.30(d)

  • Failure to perform design validation under defined operating conditions on initial production units, lots, and batches or their equivalents, as required by 21 CFR 820.30(g)

  • Failure to the design validation to ensure that devices conform to defined user needs and intended use as required by 21 CFR 820.30(g)

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
1/7/1999 CIN-WL-99-082 Cuyahoga Falls, Ohio, USA Device Reusable Compressible Limb
Warning Letter Excerpt
 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
12/24/1998 CIN-WL-99-68 Cleveland, Ohio, USA Device Ultrasonic Pachometer
Warning Letter Excerpt
  • Failure to establish and maintain written design control procedures to ensure that specified design requirements are met, for example, the firm does not have a design change procedure.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
12/18/1998 FLA-99-19 Fort Myers, Florida, USA Device Biopsy Forceps, Laparoscopic devices, and Surgical Cauterizers
Warning Letter Excerpt
 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
12/11/1998 2916737 Santa Clara, California, USA Device Ultrasound Probes
Warning Letter Excerpt
  • You have failed to ensure that written procedures for validating the device design reflect the firm's current procedures.  The investigator found that validation of the device design is currently done by [xxx] in [xxx], not by your Marketing group as indicated in the firm's written procedures. [21 CFR 820.30]

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
12/4/1998 FLA-99-17 Palm Harbor, Florida, USA Device Software
Warning Letter Excerpt
  • Failure to establish and maintain plans that describe or reference the design and development activities, and define responsibility for implementation including the plans that describe the interfaces with different groups that provide input to the design and development process [21 CFR 820.30(b)].

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
10/15/1998 2950360 Clovis, California, USA Device Contact Lenses
Warning Letter Excerpt
  • You have not established a design control procedure which defines development activities and which defines responsibility for implementation. [21 CFR 820.30(b)] This facet of the design control requirements is particularly important for a firm such as yours, which has made modifications to the original device’s design specification and which must interface with the parent company in Japan regarding design issues.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
10/9/1998 NYK-1999-2 Elmsford, New York, USA Device Dental Imaging System
Warning Letter Excerpt
  • Failure to establish and maintain an adequate design change procedure as required by 21 CFR 820.30(i).  For example, the "Design Release and Changes" Procedure No. 9.3, Rev.6, dated 4/22/97, does not adequately address how all design control requirements will be satisfied or to what point in the design control process the change should be processed.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
9/30/1998 None Milan, Italy Device

Dental X-ray Systems

Warning Letter Excerpt

  • However, you did not provide any documentation that indicates whether the new acceptance specifications had been validated or went through a design control review/process.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
9/17/1998 None Vienne France Device

Dental Lasers

Warning Letter Excerpts
  • 21 CFR 820.30(f) Design verification. Failure to establish procedures that are complete for verifying the device design. The investigator noted that multiple changes were implemented prior to June 1, 1998, affecting the value of a capacitor, control of voltage, the number of diodes, and incorporating the addition of a buzzer. This was noted in Item #1 of the FDA-483. Verification activities for these changes were not documented either before or after June 1, 1998, the effective date of the design control requirements contained in 820.30(f).

  • 21 CFR 820.30(i) Design changes. Failure of the design changes procedure to identify changes requiring design validation or, where appropriate, design verification. Item ID on the FDA-483 concerns the fact that your procedure does not identify which changes require design verification vs. design validation. Our inspection report states that the investigator discussed both design verification and validation, after which ... was advised that ... would develop a procedure that would identify verification and validation requirements, and would provide additional comments in the firm's response. Unfortunately, much of your response is in French. We need all relevant information provided to this office in English. It would appear that the changes incorporated into your procedure are the addition of a "Quality Insurance" member to the committee that reviews device modifications, the addition of a "qualification" test, and the R&D Manager being assigned the responsibility to update files for modified product. These revisions to the procedure do not appear to differentiate between design changes requiring validation vs. verification. Therefore, we consider your response to this observation inadequate. You will note that the term, "qualification," is not a term that is utilized in our Quality System Regulation. It is not clear what you mean by the term, "qualification test" or for what purpose a qualification test is conducted. Is it conducted for purposes of validation or verification? It is FDA's position that a design change must be validated to illustrate that the requirements for a specific intended use can be consistently fulfilled. However, a design change may be verified through testing, for example, when it is determined (and your procedure should specify how) that the change will not have a bearing upon the intended use but on whether the design output meets the design input requirements. The phrase, "where appropriate," used in 820.30(i) of the requirement is discussed in the Scope portion of the regulation and can be found in 820.1(a)(3), page 52655. You may find it helpful to refer to this discussion.

  • 21 CFR 820.30(g) Design validation and 21 CFR 820.75 Process validation. Failure to document that design validation had been performed to ensure that the device conformed to defined user needs and intended uses under actual or simulated use conditions.

  • 21 CFR 820.30(i) Design changes. Failure to establish and maintain procedures for the identification, documentation, validation, and where appropriate, verification, review and approval of design changes before their implementation. Items 4A and B on the 483 concern the fact that modifications were implemented prior to going through a formal approval procedure - the effective dates of the modifications precede the approval dates.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
9/8/1998 98-DT-16 Detroit, Michigan, USA Device

Heating Pads

Warning Letter Excerpts
  • For example, a purchasing control program has not been established to assure that Appliance Development Corporation is in compliance with design control requirements, and that changes to the device are made in accordance with these requirements.

  • Additional information from the Appliance Development Corporation has been submitted in a letter dated July 21,1998 from your attorney. The letter lists a number of design changes to the heating pads and the design of a new fixture to manufacture the heating pads. The letter did not provide any information if the design changes will be made in conformance with Title 21 CFR Part 820.30, Design Controls.

 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
8/27/1998 CHI-37-98 Elmhurst, Illinois, USA Device

Dental Implant Kits

Warning Letter Excerpt
 
Warning Letter Date Warning Letter ID Location Device / Biologic Product
7/7/1998 CIN-WL-98-321 Akron, Ohio, USA Device Hydraulic Stretchers and Imaging Tables with Carbon Fiber Tops
Warning Letter Excerpts

The law requires that manufacturers of medical devices adhere to the Quality System Regulation

Are You Ready? 

Purchase SOPs


Software Quality Management, Inc. (SQM), 2 Southerly Court, Suite 603, Towson, MD, 21286, USA, 410-339-5307 (v), 

410-823-8019 (f), info@sqminc.com, copyright SQM, 1997-2002, Last modified: November 18, 2009