FDA QSIT Inspection of Design Validation: Part I-Non-Software

1 Comment / FDA / By Robert Packard / Design Validation, FDA medical device regulatory compliance, FDA QSIT, medical device QSIT, medical device validation

This article reviews FDA QSIT inspection requirements of design validation and is specific to devices that do not contain software.

In the FDA QSIT Manual (http://bit.ly/QSITManual), the word “validation” appears in the QSR 78 times. This exceeds the frequency of the names “verification,” “production,” “corrective,” and the acronym “CAPA.” The word “validation” is almost as frequent as the word “management”–which appears 80 times in the QSIT Manual. The section of the QSIT Manual specific to design validation is pages 35-40.

The FDA selects only one product or product family when they are inspecting design controls. Therefore, if you keep track of which products have already been inspected by the agency, you can often predict the most likely product for the investigator to select during the next inspection. The number of MDRs and recalls reported will impact the investigator’s selection. Class I devices are not selected.

The QSIT Manual instructs inspectors to verify that acceptance criteria were specified before conducting design validation activities and that the validation meets the user’s needs and intended uses. There should also be no remaining discrepancies from the design validation. Inspectors must verify that all validation activities were performed using initial production devices or production equivalents. The last item to verify is that design changes were controlled–including performing design validation of the changes.

Risk Analysis

Risk analysis is seldom reviewed in detail–except for software risk analysis. However, when a nonconforming product is reworked, it is required to review the adverse effects of rework. QSIT inspectors will expect you to document this review of risks. Investigators will also expect risks to be reviewed and updated per trend analysis of complaints, service reports, and non-conformities. Finally, when companies assess the need to report recalls, the FDA expects to see a health hazard evaluation to be completed (http://bit.ly/HHE-Form). A detailed risk analysis review is uncommon in QSIT inspections but receives greater emphasis in reviewing CE marking applications.

Predetermined Acceptance Criteria

Investigators reviewing your design validation protocols will specifically look at the acceptance criteria for the testing you perform. Investigators are looking for two things. First, were the acceptance criteria met without deviation? Second, was the protocol approved before knowing the results (i.e., was this a prospective design validation protocol)? In certain areas, there are also known risks associated with products that the investigators will look for. For example, in sterilization validation, the investigator will verify that the validation was performed to the most current version of the standard and that the validation has addressed the most common pitfalls of sterilization. For example:

Have the most challenging devices been identified?
Has performance been validated at the maximum sterilization dose?

User Needs & Intended Uses are Met

In the area of user needs and intended uses, there are a few problems with the initial launch of devices for the intended use. Issues typically arise when companies expand the intended use to new patient populations and new intended uses. When this occurs, unique user needs and risks may need to be evaluated. Therefore, the FDA periodically reviews claims made by companies in marketing communications to ensure that claims do not stray beyond the cleared intended use of the device. This will sometimes be identified as a 483 inspection observation. Sometimes, the FDA will issue a warning letter to a company that continues to market a device for uncleared indications.

Initial Production Devices or Production Equivalents

When investigators review validation protocols and reports, the documentation must include traceability to the device’s production lot(s). Investigators may even request a copy of the Device History Record (DHR) for the production lot used for validation. If a production lot is not used, the design validation documentation must disclose how the product differs from production lots and why the results are acceptable. The samples used should be subjected to the final test/inspection requirements. If final test/inspection requirements are not yet established, samples should be retained so that they can be inspected at a later date. Without this traceability, you may have to repeat your design validation with a production lot.

Validation of Design Changes

Far too many hours are wasted writing justifications for why re-validation is unnecessary. I recommend that re-validation of the design be performed for any design change if all three of the following criteria are not met:

a sound scientific rationale can be provided with references
the logic does not require a subject matter expert to understand it
quantitative analysis is possible to analyze the risk impact

Many design validations require simulated use with a physician. Companies should obtain as much user feedback as possible before launching a device. Therefore, any re-validation that requires simulated use and user feedback should be a priority over writing a rationale for not conducting re-validation.

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Jan 22 2014

4 Ways to Create Your FDA Medical Device Regulatory Updates

Leave a Comment / FDA / By Robert Packard / Creating your own FDA medical device regulatory updates, FDA medical device regulatory compliance, FDA medical device regulatory updates, medical device consultant, medical device consulting, medical device regulatory

Although FDA medical device regulations are centrally located in one place, the FDA homepage, this blog discusses four information areas you can monitor to create your own FDA medical device regulatory updates.

Guidance documents released (FDA-guidance),
Recognized standards (Recognized-Consensus-Standards),
Device classifications (Product Classification), and
Total Product Lifecycle (TPLC) database (FDA-TPLC).

Guidance Documents

When you check the FDA website for the new draft and final guidance documents, the webpage to monitor is http://bit.ly/newFDAguidance. This page had already had four new guidance documents in 2014, and in October 2013, the FDA released an important update about the eCopy program for 510(k) submissions: FDA-eCopy.

Recognized Standards

The FDA has a separate database for all recognized consensus standards: Recognized-Consensus-Standards. This database is used to verify which Standards can be used for verification and validation testing of new devices, and the reference of any of these Standards in a device submission must also be accompanied by the completion of Form FDA 3654: http://bit.ly/Form-FDA-3654.

Device Classifications

Changes to device classifications and/or regulatory approval pathways are rare at the FDA, but you should periodically check the classification database to verify that there have been no changes. The most likely changes will be the addition or removal of recognized standards applicable to your devices. The database for looking up device classifications can be found at Product Classification.

TPLC Database

For each 3-letter product classification code, there is a database that shows all the recent 510(k) submissions and recalls and summarizes all the medical device reports submitted for severe injuries and deaths. This database, FDA-TPLC, should be monitored to proactively identify problems that occurred with similar products before they happened to your product. Also, there may be voluntary reports from user facilities regarding your device that were not reported directly to your company. The possibility of voluntary reports makes this a vital database to monitor weekly. Other resources include:

CDRH-news-updates – This is the page of the device division of the FDA (CDRH), where news and updates are posted. You may find it helpful to register for receiving the RSS feeds from this page so that you are informed of any updates as FDA posts them.
CDRH-Learn – This is the page where CDRH lists all the online training courses for medical device manufacturers. This includes popular courses such as the “Pre-market Notification Process – 510(k)s” and “Medical Device Recalls.” This page also had four recent updates: 1) “Investigation Device Exemption Process – IDE,” updated on December 6, 2013; 2) “Device Establishment Registration and Listing,” updated on July 31, 2013; 3) “Global Initiatives,” updated on October 31, 2013; and 4) “Unique Device Identification (UDI) System,” updated on December 23, 2013.

Next Steps

Review each of the above streams of information from the US FDA on a scheduled basis as preparation for quarterly management reviews and determine any potential impact on your organization’s quality system and procedures. This gap analysis should be performed by someone familiar with the specific process(es) addressed by the regulations. The most likely actions to be taken are:

Initiate specific changes to existing procedures.
Create new procedures or
Initiate a quality plan for more substantial changes to your quality system.

Management Review-Free Webinar Recording

If you need more help preparing for your management review, here’s a link to a free webinar I recorded: http://bit.ly/Clause5-6. You will also receive a management review slide deck, as well.

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Nov 4 2013

Regulatory Consulting Firm Selection

Leave a Comment / Project Management / By Robert Packard / FDA medical device regulatory compliance, medical device consulting firm, selecting a medical device consulting firm, selecting a medical device quality consulting firm

Things to consider for regulatory consulting firm selection: 1) the project scope, 2) personality, 3) qualifications, and 4) budget.

Regulatory Consulting Firm Selection

This article reviews four key considerations of regulatory consulting firm selection. Even if you already have a vice president of regulatory affairs, you still might need external regulatory consulting expertise. Regulatory consultants specialize in just the regulations and most have sub-specialties because it is impossible to know the medical device regulations in every country. Another reason for hiring a regulatory consultant is that you do not have enough bandwidth to conduct the regulatory work internally. Regardless of the scope of the project, this is a strategic decision rather than a tactical one. Regulatory approval impacts your company’s ability to sell devices and therefore a few months of delay can result in a six or seven-figure loss. In addition, the cost of the regulatory consulting fees is likely to be at least five figures. Finally, a purchasing decision of this magnitude will require C-suite approval and your Board of Directors and/or investors may get involved. Here are four critical areas to consider:

1. Defining the scope of the regulatory consulting project

Ensure that the scope, timeline, roles of the consultant/internal company team, and deliverables are crystal clear during consultant interviews and defined within the consulting contract. Do you need advice or suggestions to be carried out by your internal team? Or is “hands-on” work required (writing procedures, conducting training, executing audits, etc.)? I’ve discovered that “hands-on” can mean something entirely different to your company and the consultant. If it’s not clear who is doing the actual work, your internal resources may end up doing the work that was intended for the consultant.

Once the project scope has been clearly explained, ask the prospective consultant to provide a brief document describing how they would approach the project. This will be helpful later on when drawing up the contract. Ask which software or systems the consultant will be using to keep your project on track. A consultant who does not have any version of project management on their laptop, or is unfamiliar with such tools, is a red flag.

Make sure you select a consultant or consulting firm that matches the size of your project. Select and interview three to five companies, based on the size and complexity of the project. If the project primarily involves working at your location, consider the additional cost and travel time from where the consultant(s) is located. If the project allows for working remotely, focus more on the project management aspects mentioned in the previous paragraph, and how your company will communicate with the consultant.

2. Personality of the consultants

When you are making a regulatory consulting firm selection, don’t base your decision on word of mouth, or someone that you pick randomly online. Interviewing is an essential part of the selection process. Be wary of a consultant who talks more than listens, especially if the conversation is about their illustrious career. The consultant you speak with should be focused on the scope of your project and ask questions about your company’s capabilities. You are the client and ultimately your team will be the hero that brings a new medical device to market. The consultant you hire is an experienced guide that has learned from success and failures. Ideally, the consultant will be able to explain the process in simple terms and help you identify critical tasks in the project. Be wary of the consultant that answers every question with “It depends.” If your team’s style of project management and communication doesn’t fit the consulting firm’s style, keep looking.

3. Qualifications of the regulatory consulting firm

Don’t limit interviewing to the experience of the lead consultant or owner of the consulting firm. Make sure that you also have a resume or CV for each of the other consulting members that will be working on your project. Imagine the dismay of your internal team when you discover that the owner of the consulting firm has hired friends or former colleagues with little or none of the needed expertise. To prevent this scenario from occurring, include a technical person on the interview team to challenge the expertise of the consultant. This will help you identify a firm that knows all the right buzzwords but lacks the knowledge to accurately implement the deliverables and reduce regulatory risk within your company. Ideally, the consulting firm will have a step-by-step plan and they are able to identify the biggest potential obstacles.

You can ask for and check references for past clients for whom they have done similar work, but people seldom give you the name of a referral that will speak negatively about them. Ask for examples of work reports that the consultant has completed for other clients—with any confidential information removed. This is critical in determining if the final job will be “fluff” or real solutions for your company. It will also avoid the “one size fits all” procedures and processes that can rarely be beneficial for your company’s needs. Ask for examples of “out of the box” thinking and best practices that they’ve implemented. How do they remain current on the regulations and standards?

4. Budget for a regulatory consulting firm

Cost should not be the only determining factor in selecting a consultant. When you’re choosing someone to pave your driveway, you may be able to get away with this. When choosing a regulatory consultant for your medical device company, you want several bids, and you want to ensure that each party is bidding against the same scope and deliverables. However, choosing the least expensive bid over the one with the most expertise and best reputation may cost your company more in the long run if the work isn’t properly done or completed on time.

Contracts must be very specific with regard to milestones, timelines, and deliverables with respect to the payment schedule. What recourse does your company have when a consultant assures you during the interview process that they can meet your every need and then doesn’t? No company wants to have to pay for work that hasn’t been done and may never get done.

If the regulatory consultant is working on-site, be clear about work accommodations – office, cube, conference room, phones, access to printers and company databases, so that there are no misunderstandings once the job starts or excuses for why the work can’t get done “under these conditions.”

Conclusion

Making the best regulatory consultant firm selection is critical. If you are careful in your selection of a regulator consulting firm, you should expect an earlier market launch and a predictable process.

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