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The Three Biggest Changes in the Latest 510k Guidance

510k pmn The Three Biggest Changes in the Latest 510k GuidanceThis blog describes the three most prominent changes in the latest 510k guidance document released on July 28, 2014.

This recently issued guidance (http://bit.ly/Substantial-Equiv-Guidance) for evaluating Substantial Equivalence (SE) is well written and informative, with well-chosen and written examples. For newbies to 510ks, this is the place to start. The guidance includes background information about the 510k process and links to other documents. If you are an experienced professional, this is a must-read insight into the FDA’s current approach. Use it to guide your strategy for your next submission, and make it as easy as possible for the reviewer to reach a decision of SE for your device.


Change #1: 510k Flowchart

The 1986 flowchart guiding the decision of SE was updated and re-formatted to improve clarity. A substantial part of the guidance explains the thinking process that guides a reviewer at each decision step. If you are in the middle of preparing a submission, as I am, then the guidance provides an opportunity to review your work against current FDA thinking and training and adjust your submission to align with the FDA.


Change #2: Predicate Selection

Much has already been written about how this document may alter your selection of a predicate device. The FDA clarifies that split predicates (one for intended use equivalence, another for technological equivalence) have been ruled out. The FDA also recently released another guidance document to assist with performing a benefit/risk analysis (http://bit.ly/SE-Benefit-RIsk) when you are developing a device with a different technology than the predicate. The checklist below is intended to help you review your submission when you have already chosen an appropriate predicate.

  1. If you are using multiple predicates, have you stated which one is your primary predicate, the one that is most similar to your device? The FDA must find your device substantially equivalent to one other device.
  2. Are you using secondary predicates only when you are combining features, have more than one intended use, or have additional indications for use?
  3. Is the intended use the same as that for the predicates? Carefully compare your Intended use and the Indications for use with those of the predicates. If they are worded differently, have you explained how they are nevertheless the same?
  4. Have you provided a rationale for your choice of predicates in a way that aligns with the guidance?
  5. Is your SE table organized such that the secondary predicates only support the additional indications for use?
  6. Has your predicate been involved in a design-related recall?
  7. Double-check the Indications for Use statement in your labeling. Regulations state that the determination of the same intended use must be made against the labeling, not against what you say in the submission. Of course, what is in the submission should match the labeling.
  8. Have you included a copy of the labeling for the predicate device, e.g., the user manual?
  9. Does your Description section have sufficient information about the technical characteristics? The FDA is quite specific about what they want to see. Check your Description against the lists on page 19, and at (http://bit.ly/510k-Content) and in any device-specific guidance.
  10. Does your SE table identify similarities and differences in technological characteristics in a structured way?
  11. Do you make it clear why each of the differences does not pose a significant safety or effectiveness concern?
  12. Clinical performance data. Do the examples in the guidance suggest that you might need clinical evidence after all?
  13. If you are using an animal study, does it comply with applicable parts of GLP regulation (http://bit.ly/21-CFR-58)? This was already flagged in the RTA checklist (http://bit.ly/FDA-RTA-Policy). If the RTA reviewer can’t tick those boxes for question 39, then your submission won’t make it through the review.

Change #3: 510k Summary Template

Eleven pages, a quarter of the guidance document, are devoted to the 510k Summary, which will be posted on the FDA website. The guidance states that “FDA intends to verify the accuracy and completeness of the information included in a 510(k) Summary.” Your reviewer will have been so instructed. There is no change to the regulatory requirements for the Summary, but anyone who has combed through these while searching for a predicate will know that many Statements are incomplete. 

The FDA states that their focus on the Summary is in the interests of transparency, and they are making their point quite clearly in this guidance. As well as explaining each requirement, an example is provided. Therefore, I will be using Appendix C as a template for my 510k Summary.

Posted in: 510(k)

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6 Points for Effective Training on Medical Device QMS Procedures

%name 6 Points for Effective Training on Medical Device QMS ProceduresThe author provides 6 points for conducting effective training on medical device QMS procedures, including questions to ask for building consistent procedures.

Your Quality Management System (QMS) needs to provide objective evidence (i.e., records) that your staff is trained on procedures they use, and that their training was effective. You must also establish documented requirements for competency. The following examples might help:

  1. A record of you attending a course is a training record.
  2. A record of your taking and passing an exam related to that course is a record of training effectiveness.
  3. A record of you performing a procedure, witnessed by the trainer, is a record of competency. Your resume can also be a record of competency.

Unless a change is trivial in nature, signing a piece of paper that states you read and understood a procedure does not demonstrate training effectiveness. Learning and training are active processes that require engagement and interaction.

In a previous blog (http://bit.ly/12PartSOPTemplate), I described a slightly different procedure structure with some extra sections. There are a number of benefits to that structure, one of which is that the structure facilitates training. The additional sections are referred to in this blog. Whatever template you use, consistency of structure, and presentation across your procedures makes the procedures easier to learn and increases usability.

6 Points to Consider for Effective Training on Medical Device QMS Procedures

  1. Training requirements. For a new procedure, decide early in your writing which roles require training, what content is needed, and to what level is competency necessary. The example below is a table from a Quality Auditing procedure. The table shows the different requirements for different roles. I prefer to put this information in the procedure document—where it is unlikely to be overlooked or forgotten.training procedure 6 Points for Effective Training on Medical Device QMS Procedures
  2. Open book? For each of the roles listed above, determine whether you need trainees to be able to follow the procedure without the document at hand, or to know the procedure, and be able to find what they need.
  3. Training method. One-on-one or group? Classroom style, on-job, or remote? This depends on your company, nature of the procedure, and your requirements above.
  4. PowerPoint or not? My preference is to walk trainees through the procedure, actually have them flipping the pages and writing notes on it. If I use PowerPoint, it’s to clarify the structure and emphasize important points.
  5. Control of training copies. Paper copies of procedures and forms used for training should be controlled. Your Document Control procedure should allow for clearly marked “Training” copies to be available before the effective date. Make sure your training also reminds trainees where to find the official released a copy of procedures after training is completed.
  6. Control of training material. Include your slides, training scenarios, quizzes, etc. in your document control system. Review and revise them each time you change a procedure. 

Building Consistent Procedures: Questions to Ask and Recommendations

Use a consistent structure for your procedures, then build a consistent training structure around that. The predictability in structure will improve the effectiveness of your training.

  1. Purpose. Why are we doing this? What is the outcome we are after?
  2. Scope. When do I use this procedure? When do I not, and what do I do as an alternative?
  3. References. How does this interface to other procedures? Turtle diagrams or interface maps are useful here
  4. Definitions. Unfamiliar jargon, and terms that are used in a very specific way in this procedure
  5. Risk. What risks does this procedure address? How does this affect the design of the procedure – why are we doing it that way? Refer to my earlier blog (http://bit.ly/12PartSOPTemplate) where I explain how to include this in each procedure
  6. The procedure. Walkthrough the flowchart, explain the accompanying notes, relate the procedure flow to the responsibilities and authorities outlined earlier in the procedure
  7. Records. What do I do with the completed records from this procedure? Where do I find a copy when I need it?
  8. Examples. I suggest a training version of the form (which should be available later for reference) with guidance and examples
  9. Practice. Provide a scenario and a blank form for trainees to work through, individually or in groups
  10. Testing. Check that the training has been effective. The role competencies that were defined earlier are the basis for the effectiveness criteria for a procedure. This training module may be enough to achieve that level, or a broader training program may be required to ensure operational level competence. See Rob Packard’s blog on training exams for more advice on testing (http://bit.ly/TrainingExams)

Posted in: ISO Certification

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Procedure template for ISO ISO 13485:2016 quality systems

This 12 part procedure template for your medical device QMS can result in writing shorter, more effective documents that are easier to train personnel on.%name Procedure template for ISO ISO 13485:2016 quality systems

We all have a standard template for our quality system procedures. Typically, we begin with purpose, scope, and definitions. This 12-part procedure template for your medical device QMS  can result in shorter, more effective documents that are easier to train personnel on.

1. Purpose. Often I read something like, “This purpose of this document is to describe the CAPA procedure.” That necessary information is the reason why we title procedures. A better statement of purpose would be, “The purpose of this procedure is to provide a process for identifying, preventing and eliminating the causes of an actual or potential nonconformity, and using risk management principles.” The second version gives readers a better indication of the purpose of the procedure.

2. Scope. This section should identify functions or situations that the procedure applies to, but it is even more critical to identify which situations the procedure does not apply too.

3. References and Relationships. Reference documents that apply to the entire quality management system (e.g., – ISO 13485 and 21 CFR 820) only need to be listed in the Quality Manual. This reduces the need for future revisions to the procedures. I list here any procedure-specific external standard (e.g., – ISO 14971) in the applicable procedure. The relationship between procedures is more important than the references. Therefore, I prefer to use a simple flow diagram, with inputs and outputs, similar to the one below for a document control process.

sys 001 Procedure template for ISO ISO 13485:2016 quality systems

4. Document Approval. Who must sign off on the procedure? Keep this list short. Ideally, just the primary process owner and Quality Manager (to ensure consistency and integrity across the quality management system).

5. Revision History. A brief listing of each revision and a brief description of what was changed in the procedure.

6. Responsibilities and Authorities. A listing of the main areas of responsibility for each role. Remember to include the title of managers who may be required to approve forms, or make key decisions.

7. Procedure. I prefer to create a detailed flowchart outlining each step of a process before writing the procedure. Each task box in the flowchart will include a reference number. If you organize the reference numbers in an outline format, then you can write the text of your procedure to match the flowchart—including the numbering of the flow chart task boxes.

example Procedure template for ISO ISO 13485:2016 quality systemscapa Procedure template for ISO ISO 13485:2016 quality systems

8. Monitoring and Measurement. An explanation of how the process is monitored and measured, who does it, how often, format, method of communicating the analysis, and what process that analysis will be an input into, e.g., Management Review.

9. Training/Retraining. Tabulated, which roles need to be trained in this procedure, and to what level? The example below is also from a Document Control procedure.role Procedure template for ISO ISO 13485:2016 quality systems

10. Risk Management. This section identifies risks associated with each procedure and how the procedure controls those risks. As well as complying with the requirement to apply risk management throughout product realization (i.e., Clause 7 of ISO 13485), including a section specific to risk management forces the author of the procedure to think of ways the process can fail and to develop ways to avoid failure. Risks can also be a starting point for training people on the procedure.

11. Records. Tabulated, form number and names, a brief description of its purpose, and a column for retention and location. This column also allows for reference to compilations if the record becomes part of, e.g., Design History File, Device Master Record, or the Risk Management File.

12. Flowcharts. Step-by-step through the process, saying who performs the step when it isn’t apparent. I keep task shapes simple: rectangles for tasks, rounded rectangles for beginnings and endings, diamonds for decision boxes, and off-page reference symbols.

When the task needs supporting text, e.g., guidance or examples, put a number in the box and a corresponding number in the table in (7) above.  Ideally, the flowcharts are placed in the document with the Notes table on the same page or the opposite page. In practice, I often put them at the end to simplify the layout. One of my clients loves her flowcharts and puts them on the front page.

Benefits of this Approach

Information is well structured and presented consistently across procedures, more so than can be achieved through narrative.

  • The flowchart is the primary means of documenting the procedure.
  • Tables provide details that are not clear in the flowchart.

The procedure structure described above facilitates a consistent training approach built around the document. Purpose and scope are presented first, and then the Risk section is presented to explain what is essential in the procedure and why. The flowchart, the table, and the formwork together to describe each step of the procedure. Finally, a PowerPoint template can be used to guide process owners in developing their training.

And to make it even easier, you have already spelled out who needs to be trained and to what level.

Posted in: ISO Certification

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