Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals

Quality System

Design Controls (§ 820.30)

All manufacturers (including specification developers) of Class II and III devices and select Class I devices are required to follow design controls [§820.30] during the development of their device. The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution.

The manufacturer (including specification developer) must establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met [820.30(a)]. Design controls include establishing and maintaining plans that describe the design and development activities and also define responsibility for implementation [820.30(b)]. The plans must identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process [820.30(b)]. The design process also includes:

• Conducting a risk analysis [820.30(g)];
• Identifying design input or requirements for the device [820.30(c)];
• developing the design output or specifications for the device [820.30(d)];
• verifying that the design output meets the design input [820.30(f)];
• holding design reviews at appropriate points during the design process to identify significant problems with the design or the design process [820.30(e)];
• validating that the design meets defined user needs and intended uses [820.30(g)];
• validating any software used in the device [820.30(g)];
• transferring the device design to production specifications [820.30(h)];
• controlling changes to the design during the design process and changes in the design of products on the market [820.30(i)]; and
• documenting design control activities in the design history file [820.30(j)].

  PMA submissions should include a complete description of design controls that the manufacturer implements to comply with the QS regulation. If this information is lacking, FDA cannot complete the premarket review process.

The manufacturer must have procedures in place and must maintain documentation in the design history file to demonstrate compliance with the design control requirements of §820.30 and completion of the activities identified in the design plan. The design history file must be made available for FDA inspection. FDA will evaluate the adequacy of manufacturers' compliance with design control requirements in pre-approval inspections for Class III devices and also during routine quality systems inspections for all classes of devices subject to design control.

The following documents provide additional guidance on the design control requirements under the Quality System regulation.

Design Control Guidance for Manufacturers
http://www.fda.gov/cdrh/comp/designgd.html

Do It by Design
http://www.fda.gov/cdrh/humfac/doit.html

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Manufacturing Controls [§814.20(b)(4) and §820]

The PMA submission must include a complete description of the methods used in, and the facilites and controls used for, the manufacture, processing, packing, storage, and where appropratiate, installation of the device. The description must include sufficient detail that a person generally familiar with the Quality System/Good Manufacturing Practice requirements can make a knowledgeable judgment about the quality control used in the manufacturing of the device.

Device manufacturers include not only facilities that manufacture or assemble the finished device but also facilities operated or contracted by the PMA applicant to perform a segment of the manufacturing operation such as sterilization or packaging. Contracted facilities may either provide the required manufacturing information applicable to their operation directly to the PMA applicant for inclusion in the PMA submission or submit such information directly to FDA in a Device Master File. The PMA applicant should provide written authorization to reference the Device Master File information in the PMA submission.

While the Office of Device Evaluation (ODE) reviews an original PMA or a PMA supplement requesting approval for an alternate or additional manufacturing facility, the Office of Compliance (OC) will review the Quality System design and manufacturing information in the PMA submission. OC will determine whether the manufacturer has described the processes in sufficient detail and make a preliminary determination of whether the manufacturer meets the QS requirements. If the manufacturer has provided an adequate description of the design and manufacturing process,a preapproval inspection can be initiated.

FDA has prepared a guidance document to assist manufacturers in preparing and maintaining manufacturing information required in PMA and PMA supplements.
The guidance and 21 CFR 820, the Quality System Regulation, is intended to ensure that the manufacturing section in the PMA complies with the content requirements under §814.20(b)(4) and is sufficiently compete and appropriately organized for review.

The following document provides guidance for the preparation of quality system design and manufacturing information to be included in the PMA.

Quality System Information for Certain Premarket Application Reviews
http://www.fda.gov/cdrh/comp/guidance/1140.html
http://www.fda.gov/cdrh/comp/guidance/1140.pdf

Process validation is a key requirement of the Quality System Regulation and will be reviewed during the facility inspection process. The following guidance documents provide guidance on performing process validations.

Guideline on General Principles of Process Validation
http://www.fda.gov/cdrh/ode/425.pdf

Process Validation Guidance for Medical Device Manufacturers, Global Harmonization Task Force
http://www.ghtf.org/sg3/inventorysg3/sg3-n99-10.pdf
http://www.ghtf.org/sg3/inventorysg3/sg3-n99-10.doc

Please note that the GHTF guidance is intended for use by manufacturers worldwide who must comply with other regulatory systems in as well as the U.S.'s system. The guidance provides an option described on page XX that is not available to manufacturers distributing devices in the U.S. That option is to neither validate nor fully verify a low-risk manufacturing process, but to accept the risk. We repeat, neither validating nor fully verifying a low risk process is not an option for manufacturers who distribute devices in the U.S. The Quality System Regulation requires that manufacturing processes be validated if they cannot be fully verified.

Additional guidance on the Quality System regulation can be found on the Internet at
http://www.fda.gov/cdrh/comp/gmp.html

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Preapproval Inspection

In making the determination of the firm's ability to design, manufacture or process the device, the Office of Compliance (OC) may issue an inspection assignment to the appropriate FDA district office. The inspection assignment will be issued when OC has determined that the manufacturer has demonstrated in the PMA submission that the design and manufacturing process meets the QS regulation requirements and the facility is ready for inspection.

Inspection will include an assessment of the firm's capability to design and manufacture the device as claimed in the PMA and confirm that the firm's Quality System is in compliance with 21 CFR 820, Quality System Regulation. The inspectional process considers the extent to which the firm has established a formal QS program and has assured that the approved design is properly translated into specifications via process validation. The inspection will follow guidance outlined in Medical Device Premarket Approval Inspections, C.P. 7383.001, and Inspections of Medical Device Manufacturers, C.P. 7382.845. For a copy of C.P. 7383.001, email DSMICA at dsmica@cdrh.fda.gov.

PMA Compliance Program #P91-3 (blue book memo)
http://www.fda.gov/cdrh/p91-3.html

Inspections of Medical Device Manufacturers, C.P. 7382.845
http://www.fda.gov/ora/cpgm/default.htm#devices

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Postapproval Inspections

Postapproval inspections are conducted within eight to twelve months of approval of the PMA submission. The inspection will primarily focus on any changes that may have been made in the device design, manufacturing process, or quality systems. Inspections are conducted in accordance with Inspections of Medical Device Manufacturers, C.P. 7382.845.
http://www.fda.gov/ora/cpgm/default.htm#devices

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Updated May 14, 2003

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