FDA & ISO DMR/MDF vs. “Design Output”

Posted by Kevin Randall In Design & Development, Design Control, FDA QMS, ISO QMS, Uncategorized 0 comment

April 1, 2019

FDA & ISO DMR/MDF vs. “Design Output”

Remember that the DMR is intrinsically linked to the design control process. The DMR is by formal definition a design output (see my preceding blog post). It unequivocally lives and breathes in direct relationship to the design control process. A properly-maintained DMR never becomes decoupled from the design control process. Indeed, decoupling the DMR and the design control process is a certain recipe for an FDA 483.

As the product life-cycle evolves and DMR changes are needed, they by regulation are not allowed to happen apart from the design change requirements of the design control process. Even more eye-opening is that, if there is ever a change to design outputs (and thus the DMR), then it must always be paired with corresponding design verification and perhaps also design validation. Oftentimes, this in addition means there was a change in the underlying design inputs.

Another way to say all this is that if there is ever a change to the DMR, then it inherently means there was a “design change”. That is the reason FDA doesn’t permit us to maintain the DMR independent of the design control process. The associated use of a general (e.g., 21 CFR 820.40) document control process may create the impression that this is independent of 820.30 design controls; however, that is not the intent of the design control and DMR regulations.

For example, FDA has stated that “…Post-production design changes [which would include DMR changes] require the firm to loop back into the design controls of Section 820.30 of the regulation…[Emphasis added by ComplianceAcuity]. Similarly, FDA has also clarified that, “…The design change control section is linked to and is redundant with Section 820.70(b) Production and process changes of the regulation…” [though this particular citation focuses solely on the manufacturing section(s) of the DMR]. For additional insights about design changes and thus how the DMR must be maintained in direct correlation with design controls, check out my corresponding related blog post.

If you are careful to assure that your DMRs don’t wander away from the design control mechanism, then you’ll more easily avoid consequent DMR nonconformities and regulatory citations.

FDA & ISO 13485 Design Outputs and the DMR

Posted by Kevin Randall In Design & Development, Design Control, Uncategorized 0 comment

FDA & ISO 13485 Design Outputs and the DMR

Remember that for FDA-regulated firms, design output is formally defined in 21 CFR 820.3(g) as, “…the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record…” [Emphasis added by ComplianceAcuity]. This definition is also compatible with the corresponding requirements in ISO 13485:2016 clause 7.3.4.

Here are some pointers to help derive, manage, and maintain design outputs relative to the DMR and DHF:

A. The realization of design outputs is an iterative effort:

The realization of design outputs is an iterative effort done as follows:

Translate design inputs into final engineering specifications and solutions comprehensively meeting all of the targeted parameters and characteristics itemized in the design inputs.
Define and document design output in objective terms allowing an adequate evaluation of conformance to design input requirements. Do this by defining design outputs in objective, tangible terms, and by using a trace matrix (see step B. below).
Make reference to acceptance criteria. (Note: The acceptance criteria and test methods for the final design output are ultimately established and vetted during design verification and thereafter translated into the final Device Master Record in the form of final product, labeling, packaging, and process specifications.)
Identify and distinguish the design outputs that are essential for the proper functioning of the device (i.e., those that will ultimately make up the Device Master Record, as well as those derived from the risk-control design inputs conceived via risk analysis to mitigate unacceptable risk).
Document and approve probationary design output as needed (prior to final verification/validation) via AR (Advance Release) numeric revisions.
Initiate trial builds as necessary to adjust the product or process design, test equipment, facilities, etc., as needed to meet design input requirements.
Progressively update AR versions of design outputs as the design evolves toward the final design alpha-rev outputs and final/release.

B. Ultimately, ensure that design outputs in all cases include proper traceability:

Ultimately, ensure that design outputs in all cases include proper traceability, meaning backward traceability to the originating design inputs, and forward to corresponding verification and validation. Accomplish this by recording the design outputs in the ‘Output’ column of a trace matrix.

C. Finally, be sure to include or reference the design outputs in the DHF:

Finally, be sure to include or reference the design outputs in the DHF way of the trace matrix and also the DHF indexes created per your DHF procedures.

New European Medical Device Regulation 2017/745 Date of Application 26 May 2021

Posted by ComplianceAcuity In CE Mark, EU MDR 0 comment

October 2018 updated 2020

New European Medical Device Regulation 2017/745 Date of Application 26 May 2021

European authorized representatives and others have recently cited an apparent lag in medical device manufacturer preparedness for the new European Medical Device Regulation 2017/745. ComplianceAcuity has always been on the cutting edge of organic compliance with European device requirements, with its Principal one of the inaugural small group of individuals in the world to achieve the European Union Regulatory Affairs Certification (EU RAC). Please contact us for more information on how we may be able to help you complete your EU MDR transitional efforts.

From the Archives: ISO 13485:2016 Deadline nearly upon us…

Posted by ComplianceAcuity In News 0 comment

October 2018

The three-year transition period of ISO 13485:2016, “Medical Device – Quality Management Systems – Requirements for regulatory purposes” will conclude on February 28, 2019. Specifically, organizations’ ISO 13485:2003 certificates will no longer be valid as of March 1, 2019. ComplianceAcuity clients have already achieved multiple transitions to ISO 13485:2016 with ComplianceAcuity’s help and leading transitional tools and resources. Please contact us for more information on how we may be able to help you complete your transitions by the deadline.

U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity

Posted by Kevin Randall In Uncategorized 0 comment

October 2018

U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity…

Links to the draft guidance and corresponding Federal Register notice are provided below:

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM623529.pdf

https://www.federalregister.gov/documents/2018/10/18/2018-22697/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-draft-guidance

From the Archives: Final draft of New ISO 13485 Medical Devices Quality Management System Standard published…

Posted by ComplianceAcuity In News, Uncategorized 0 comment

October 2015

For several years ISO 13485:2003 (which is the heart of BS EN ISO 13485:2012) has been under revision. After incorporation of numerous comments and feedback from many international stakeholders, a final draft of the standard has now been released by ISO Technical Committee 210. It is expected that the final standard will be published in spring 2016.

The changes aim to more holistically address the entire medical device lifecycle and supply chain. Some key points of emphasis include supplier controls, quality feedback processes, software controls, integration of risk management in the QMS, clarifications of design verification and validation, and general harmonization with regulatory requirements.

FDA DRAFT guidance for animal studies of medical devices…

Posted by ComplianceAcuity In FDA 0 comment

October 2015

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “General Considerations for Animal Studies for Medical Devices.” FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The intent of this draft guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption (IDE) application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. This draft guidance is not final nor is it in effect at this time. Submit either electronic or written comments on the draft guidance by January 12, 2016. Link to the federal register notice below:

http://www.gpo.gov/fdsys/pkg/FR-2015-10-14/pdf/2015-26055.pdf

Status of revisions to the European Medical Devices Directive…

Posted by ComplianceAcuity In News, Uncategorized 0 comment

September 2015

For updates from the European Commission regarding revision of the European MDD, click the link below:

http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm

FDA updates guidance for its 510(k) Refuse to Accept Policy…

Posted by ComplianceAcuity In FDA 0 comment

August 2015

FDA released updated guidance addressing its screening acceptance process for 510(k) notifications. FDA has also made corresponding changes to the associated ‘Acceptance Checklist for 510(k)s’.

The revised guidance provides updates explaining the current procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The new guidance is effective on October 1, 2015 and supersedes three predecessor documents from 1993, 1994, and 2012. Links to the revised guidance and updated checklists are provided below:

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm071360.htm

FDA DRAFT guidance distinguishing device recalls from enhancements…

Posted by ComplianceAcuity In FDA 0 comment

February 2013

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements for both recalls and product enhancements. The draft guidance is not final nor is it in effect at this time. Submit either electronic or written comments on the draft guidance by May 23, 2013. Link to federal register notice here.

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FDA & ISO DMR/MDF vs. “Design Output”

If you are careful to assure that your DMRs don’t wander away from the design control mechanism, then you’ll more easily avoid consequent DMR nonconformities and regulatory citations.

FDA & ISO 13485 Design Outputs and the DMR

A. The realization of design outputs is an iterative effort:

The realization of design outputs is an iterative effort done as follows:

B. Ultimately, ensure that design outputs in all cases include proper traceability:

Ultimately, ensure that design outputs in all cases include proper traceability, meaning backward traceability to the originating design inputs, and forward to corresponding verification and validation. Accomplish this by recording the design outputs in the ‘Output’ column of a trace matrix.

C. Finally, be sure to include or reference the design outputs in the DHF:

Finally, be sure to include or reference the design outputs in the DHF way of the trace matrix and also the DHF indexes created per your DHF procedures.

New European Medical Device Regulation 2017/745 Date of Application 26 May 2021

U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity…