FDA QMSR Design Documentation

In our previous post, we wrote about the requirements for the Medical Device File as per Quality Management System Regulation (QMSR) and discussed what constitutes a Medical Device Family. In this post, we will discuss what is included in the FDA QMSR Design Documentation. You can see the final QMSR rule here.

No More DMR, DHF and DHR

During the review stage of the proposed FDA Quality Management System Regulation (QMSR) Rule, some industry members commented that terms such as DMR (Device Master Record), DHF (Design History File), and DHR (Device History Record) do not appear in ISO 13485 and asked FDA to clarify whether those terms are included in the new rulemaking. FDA agreed that ISO 13485 does not contain requirements for record types specified in the old QS regulation, and therefore decided not to retain separate requirements for DMR, DHF, and DHR in the new QMSR. However, this doesn’t mean that the content of these records is not required.

Design Documentation

FDA explained that the elements that comprise DMR, DHF, and DHR are now included in the ISO 13485 under Clause 4.2 – Documentation requirements and in Clause 7 – Product realization. For example, many of the requirements previously in the DHR are largely required to be in the medical device or batch record, as described in Clause 7.5.1 (Control of production and service provision):

a) documentation of procedures and methods for the control of production;

b) qualification of infrastructure;

c) implementation of monitoring and measurement of process parameters and product characteristics;

d) availability and use of monitoring and measuring equipment;

e) implementation of defined operations for labeling and packaging;

f) implementation of product release, delivery, and post-delivery activities.

As for the Medical Device File, the organization shall establish and maintain a record for each medical device or batch of medical devices related to traceability requirements defined in ISO 13485 (7.5.9) and will identify the amount manufactured and approved for distribution. Such records will be verified and approved.

Similarly, consistent with the former DHF, as per clause 7.3.10 (Design and development files) manufacturers should have a Design and Development File for each medical device type or medical device family, Such file shall contain or reference all the records necessary to establish compliance with design and development requirements, including the design and development plan, design and development procedures as well as design and development changes. We hope to clarify the requirements for these documents in one of our future articles.

QMSR Design and Development – Devices Types

There were several comments regarding the proposed Design and Development requirements – 820.10(c). FDA explained that the proposed Quality Management System Regulation (QMSR) retains the scope of the previous 820.30(a) of the QS regulation and does not modify which devices are subject to these requirements. The manufacturers of class II and class III, and certain class I devices must comply with the requirements in, clause 7.3 (Design and Development).

The I devices types include:

Devices automated with computer software;
Catheter, Tracheobronchial Suction (section 868.6810)
Glove, Non-powdered Surgeon’s (878.4460)
Restraint, Protective (880.6760)
System, Applicator, Radionuclide, Manual (892.5650)
Source, Radionuclide Teletherapy (892.5740)

In addition, the manufacturers of devices that support or sustain life must comply with the requirements in Traceability for Implantable Devices, Clause 7.5.9.2, in addition to all other applicable requirements in this part, as appropriate. Devices that support or sustain life include devices, the failure of which, could reasonably expected to result in a significant injury. FDA also clarified that device and development requirements, apply to all finished devices.

However, the FDA is consistent with ISO 13485, which recognizes that there may be exclusions by the regulatory authority from the Design and Development requirement and manufacturers are required to document the justification for the exclusion.

Design Records For Early Development Stages

FDA explained that manufacturers are not expected to maintain records of changes during the very early stages of the design process. The manufacturers are expected to document design changes made after the initial design inputs have been approved, and any changes made to correct design deficiencies once the design has been released to production. Therefore, we advise companies to clearly define in their Design Development procedure the exact point when the design work must be documented. The FDA further clarified that the purpose of design reviews during the design phase is to ensure that the design satisfies the design input requirements for the intended use of the device and the needs of the user.

Design Review

Design reviews should be conducted at major decision points during the design phase and should include the review of design verification data to assess whether:

the design outputs meet functional and operational requirements,
the design is compatible with components and other accessories,
the safety requirements are achieved,
the reliability and maintenance requirements are met,
the labeling and other regulatory requirements are met, and
the manufacturing, installation, and servicing requirements are compatible with the design specifications.

For a large manufacturer, design review provides an opportunity for all those who may have an impact on the quality of the device to provide input, including manufacturing, quality assurance, purchasing, sales, and servicing divisions. While small manufacturers may not have the broad range of disciplines found in a large company, and the need to coordinate and control technical interfaces may be lessened, the principles of design review still apply. The requirements under 820.30(e) allow small manufacturers to tailor a design review that is appropriate to their individual needs.

QMSR waives the QS regulation requirement that each stage of design review should include an individual(s) who does not have direct responsibility for the design stage being reviewed – the independent reviewer. It is now left to organizations (as per 7.3.5) to select individual(s) for each stage of the design review.

Design and Development Inputs and Outputs

FDA considers that successful quality management system under Clause 7.3.3 (Design and development inputs) and 7.3.4. (Design and development outputs) require a similar approach to design review and validation as those developed under the QS regulation.

Design and development inputs relating to product requirements should include:

functional, performance, usability and safety requirements, according to the intended use;
applicable regulatory requirements and standards;
applicable output(s) of risk management;
as appropriate, information derived from previous similar designs;
other requirements essential for design and development of the product and processes.

These inputs shall be reviewed for adequacy and approved. Requirements shall be complete, unambiguous, able to be verified or validated, and not in conflict with each other.

Design and development outputs should:

meet the input requirements for design and development
provide appropriate information for purchasing, production and service provision;
contain or reference product acceptance criteria; and
specify the characteristics of the product that are essential for its safe and proper use.

The outputs of design and development shall be in a form suitable for verification against the design and development inputs and shall be approved before the release. Records of the design and development outputs shall be maintained.

BioReg Services

Don’t hesitate to contact us for any assistance on FDA QMSR Design Documentation. Our team can provide cost-effective help with all ISO 13485 Transition, CE EU-MDR Certification or other Quality & Regulatory Consulting tasks.

BioRegards,

Daniel

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FDA QMSR Design Documentation