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

qsit FDA QSIT Inspection of Design Validation: Part I Non Software This article reviews FDA QSIT inspection requirements of design validation, and is specific to devices which 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 word “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 have an impact on the investigator’s selection. Class I devices are not selected.

The QSIT Manual instructs inspectors to verify that acceptance criteria were specified prior to conducting design validation activities, and that the validation meets the user 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 great detail–except software risk analysis. However, when 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 in accordance with trend analysis of complaints, service reports and nonconformities. 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 review of risk analysis is uncommon in QSIT inspections, but receives a greater emphasis in the review of CE marking applications.

Predetermined Acceptance Criteria

Investigators reviewing your design validation protocols will specifically look at the acceptance criteria for testing you perform. Investigators are looking for two things. First, were the acceptance criteria met without deviation? Second, was the protocol approved prior to 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 most common pitfalls of sterilization have been address by the validation. 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 few problems with the initial launch of devices for the intended use. Problems typically arise when companies expand the intended use to new patient populations and new intended uses. When this occurs, there may be new user needs and risks that 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, and in certain cases, 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 production lot(s) of the device. 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, then 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 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 not required. I recommend that re-validation of design be performed for any design change if all three of the following criterion are not met:

  1. a sound scientific rationale can be provided with references
  2. the logic does not require a subject matter expert to understand it
  3. 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.

Posted in: FDA

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4 Ways to Create Your Own FDA Medical Device Regulatory Updates

Although FDA medical device regulations are centrally located in one place: http://bit.ly/FDA-homepage, this blog discusses four information areas you can monitor to create your own FDA medical device regulatory updates-(guidance docs, standards,) etc.

fdaupdates 4 Ways to Create Your Own FDA Medical Device Regulatory Updates

  1. Guidance documents released (http://bit.ly/FDA-guidance),
  2. Recognized standards (http://bit.ly/Recognized-Consensus-Standards),
  3. Device classifications (http://bit.ly/ProductClassification), and
  4. Total Product Lifecycle (TPLC) database (http://bit.ly/FDA-TPLC).

Guidance Documents

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

Recognized Standards

The FDA has a separate database for all recognized consensus standards: http://bit.ly/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 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 addition or removal of recognized standards applicable to your devices. The database for looking up device classifications can be found at: http://bit.ly/ProductClassification.

TPLC Database

For each 3-letter product classification code, there is a database that shows all the recent 510(k) submissions, all recalls and summarizes all the medical device reports submitted for serious injuries and deaths. This database, http://bit.ly/FDA-TPLC, should be monitored to proactively identify problems that occurred with similar products before they happen to your product. In addition, 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 an important database to monitor weekly. Other resources include:

  1. http://bit.ly/CDRH-news-updates – This is the page 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.
  2. http://bit.ly/CDRH-Learn – This is the page where CDRH lists all of 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 to your organization’s quality system and procedures. This gap analysis should be performed by someone that is familiar with the specific process(es) addressed by the regulations. The most likely actions to be taken are:

  1. Initiate specific changes to existing procedures
  2. Create new procedures, or
  3. 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.

Posted in: FDA

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4 Things to Know When Selecting a Medical Device Consulting Firm

choosing a consultant 300x300 4 Things to Know When Selecting a Medical Device Consulting FirmThe author reviews 4 things to know when selecting a medical device consulting firm, including defining the project scope, interviewing, budget and contract. 

Medical Device companies utilize consultants for various reasons, including: a lack of technical expertise within the company, avoidance of hiring full-time employees for a relatively short-term project and gap analyses for FDA readiness or notified body audit. Have you ever been tasked with choosing a consultant to help with a critical project, but the consultant you selected failed to meet your needs? Not to worry, you’re not alone. Unfortunately, consultants sometimes make commitments for work they are not qualified to do. Here are four critical areas to consider when selecting a consultant to help ensure a positive and productive experience.

1. Defining the project scope

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, and 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 own 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 upon the project management aspects mentioned in the previous paragraph, and how your company will communicate with the consultant.

2. Interviewing

When selecting your consultant, don’t base your decision on word of mouth, or someone that you pick randomly online. Interviewing is an important part of the selection process. Be wary of a consultant who talks more than listens, especially if the conversation is about their illustrious career. This person should be focused on the scope of your project and asking questions about your company and the project team. You also need to beware consultants with a patronizing attitude. If you are an experienced medical device professional and the consultant starts to explain the definition of GMP, the consultant has not taken the time to understand their audience. Any consultant that is this disrespecting deserves to be chopped from your list of potential service providers early. 

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 in order to challenge the expertise of the consultant. This will help you identify a firm that knows all the right buzz words, but lacks the knowledge to accurately implement the deliverables and reduce regulatory risk within your company.

Ask for and check references for past clients for whom they have done similar work. 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?

3. Budget

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 consultant for your medical device company, you definitely want a number of 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.

4. Contract

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.

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

Choosing the right consultant for your company is critical. They don’t come cheap, and if the work could be accomplished by your staff, you would not be hiring a consultant in the first place. If you are careful in your selection of a consultant or a consulting firm, you may be rewarded with a new partner that can help you grow your business for many years.

Posted in: Project Management

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