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Hiking Expedition

On August 9, 2019 three generations of my family left Glastonbury, CT on a two week hiking expedition to complete three of the highest peaks in the USA.

Our plan for the hiking expedition was to hike four of the highest peaks. My father, Bob Packard (age 77), is trying to complete all 50 of the highest peaks in each of the United States. For this trip we planned to hike the following peaks:
  1. Wheeler Peak – New Mexico
  2. Kings Peak – Utah
  3. Borah Peak – Idaho
  4. Granite Peak – Montana

Bailey Packard (18), Noah Packard (20), Rob Packard (47) and Bob Packard (77) started on Friday, August 9 from Glastonbury, CT.

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Glastonbury, CT

Then we drove West….for a really long time. On Saturday, August 10 we stopped at the Waffle House.

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Waffle House

Then we got back in the car…

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Finally, on Sunday, August 11 we arrived in at the base of Wheeler Peak. We decided to hike it that day despite not acclimating to the altitude and not sleeping in two days.

4 Bailey Base of Wheeler e1566919907502 225x300 Hiking Expedition

Bailey Packard

5 Noah Base of Wheeler e1566919966989 225x300 Hiking Expedition

Noah Packard

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Wheeler Peak

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Then we headed back across the ridge and down to the car. The evening we drove to Colorado and slept. The following morning, Monday, August 12, we drove through Colorado…

Driving through Colorado 300x169 Hiking Expedition

That evening we arrived at Henry’s Fork Trail Head in Utah several hours after dark. We pitched tents in the parking area, and slept for the night. In the morning, Tuesday, August 13, we woke to ice on our tents. Then we began the long hike into valley (see Bailey’s video above).

Entering Valley Near Kings Peak 300x169 Hiking Expedition

We were all carrying too much gear, and we needed some rest.

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While we enjoyed the view of the valley…

Taking a Break on Kings Peak Day 1 from a different view 300x169 Hiking Expedition

Later we saw a couple of moose (Bailey got close enough for a selfie).

Bailey says hello to the Moose 300x169 Hiking Expedition

We slept the night just below Gun Sight Pass, and then headed up Kings Peak in the morning of Wednesday, August 14.

Kings Peak Group Photo 300x169 Hiking Expedition

Another spectacular view…

Kings Peak View 300x169 Hiking Expedition

Then we headed back across the ridge (very challenging and exposed).

Kings Peak Ridge 300x169 Hiking Expedition

That afternoon Bailey got lost, but we found him back at the tents several hours later just before dark. Noah was exhausted and took a nap in the middle of the Gun Sight Pass. We all slept well, and hiked back to the car in the morning of Thursday, August 15.

Dad Taking a Break e1566921771896 169x300 Hiking Expedition

Then we drove to Idaho Falls, and we had all you can eat steak at Stockman’s.

We took at rest day on Friday, August 16. On Saturday it was perfect weather and we drove to Borah Peak in Idaho–just two hours Northwest from Idaho Falls. We arrived just after 6am and began hiking as the sun rose.

Borah Peak 300x225 Hiking Expedition

Now I understand why Wheeler was rated a 1+ in difficulty, Kings Peak was rated a 2+ in difficulty and Borah is 3+ in difficulty. There is a 2,000+ foot cliff on both sides of a goat path across a knife edge. There is sharp, jagged shale everywhere and no trees. Winds are fierce, and it’s not a windy day. Temperatures were in the low 40s. I decided to “chicken out” just before we got to “Chicken Out Ridge”.

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Where Rob waited for the others.

The ice bridge was not expected, and dozens of weekend hikers with no experience were trying to crawl across the ice. Bailey used his knife for extra grip on the ice. Bob was almost knocked off the mountain by a falling boulder and they made it to the peak…waiting for Bailey’s pictures to be added later.

Then we all headed down the mountain.

Dad and Bailey on Borah e1566921715900 225x300 Hiking Expedition

Noah on Borah e1566921886585 225x300 Hiking Expedition

Rob on Borah e1566921940799 225x300 Hiking Expedition

The following day, Sunday, August 18, we drove home…our feet were too sore to attempt Granite Peak. But along the way, we stopped on Monday, August 19 at Portillo’s for

Thank you for your support, and thank you to Noah and Bailey for joining me and my dad on this hiking expedition. These are memories we’ll never forget.

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FDA User Fees FY2020

This article is a reminder that the new FDA User Fees FY2020 have been announced, and it is time for you to re-apply for small business qualification.

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FDA User Fees FY2020 = 5.85% Increase in 510(k) User Fee

In 2016 the FDA and industry negotiated revised user fees to achieve faster decision timelines. In return for higher user fees, the FDA promised faster decision timelines. This agreement ultimately became the Medical Device User Fee Amendments of 2017 (i.e., MDUFA IV). This new higher fee structure was implemented in FY 2018 (i.e., October 2017). The MDUFA IV agreement also included plans for inflation adjustments each year. Therefore, on July 31, 2019 the FDA announced the new inflation-adjusted pricing for FDA User Fees FY2020 in the Federal Register.

This new pricing for the medical device user fees is published in Table 5 of the July 31st announcement. All of the fees increased. The 510k standard user fee, for example, increased from $10,953 to $11,594–and increase of 5.85%. The FDA also sent out an email update about the increased user fees last week.

Prior to FY 2019, companies were not able to apply for small business status until October 1. However, in August 2018 the FDA changed the forms, guidance and policies to allow companies to apply for small business status as soon as August 1. The form also now allows the applicant to fill-in the applicable fiscal year. This eliminates the need for the FDA to update the application form each year.

The approval of small business status by the FDA can take up to 60 days. Therefore, every small business planning to submit a regulatory submission to the FDA in FY 2020 should apply for small business status now–instead of waiting until October or when they are planning to submit. This will reduce the possibility of a company needing to submit their submission before they have been qualified by the FDA as a small business and paying the higher standard user fee.

When you submit your application, make sure that you send an original application, because the FDA will not accept a copy–especially for international submissions. Companies located outside the USA, or companies with subsidiaries outside the USA, must obtain verification of the taxes paid by the national tax authority in each country. This extra step makes it even more critical for device companies to start the application process immediately.

In parallel with these annual user fee increases, Medical Device Academy increased our flat-fee pricing for preparing submissions on August 1. The new higher consulting fee increased from $12,000 to $14,000. This fee does not include our flat-fee for each FDA eCopy of $150/eCopy–typically averaging $600/project. However, we now include any time required to response to RTA Hold Letters and requests for additional Information. This typically ranges from 5-10 hours of consulting time at $300/hour. Therefore, the net change is from $14,250 to $14,600 (i.e., an increase of 2.46%). More importantly, it makes the total cost of hiring our firm more predictable and less time consuming for our firm to quote. Our firm’s hourly rates have not changed.

If you are interested in learning more about applying for small business status, please visit our webinar page on this topic or contact us for help. If you are interested in our new pricing, please click on the download button found on our home page.

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Auditing Technical Files

This article explains what to look at and what to look for when you are auditing technical files to the new Regulation (EU) 2017/745 for medical devices.

Auditing Technical Files what to look at and what to look for 1024x681 Auditing Technical Files

Next week, August 8th @ Noon EDT, you will have the opportunity to watch a live webinar teaching you what to look at and what to look for when you are auditing technical files. Technical files are are the technical documentation required for CE Marking of medical devices. Most quality system auditors are trained on how to audit to ISO 13485:2016 (or an earlier version of that standard), but very few quality system auditors have the training necessary to audit technical files.

Why you are not qualified for auditing technical files

If you are a lead auditor, you are probably a quality manager or quality engineer. You have experience performing verification testing and validation testing, but you have not prepared a complete technical file yourself. You certainly can’t describe yourself as a regulatory expert. You are a quality system expert. A couple of webinars on the new European regulations is not enough to feel confident about exactly what the content and format of a technical file for CE marking should be.

Creating an auditing checklist

Most auditors attempt to prepare for auditing the new EU medical device regulations by creating a checklist. The auditor copies each section of the regulation into the left column of a table. Then the auditor plans to fill in the right-hand columns of the table (i.e., the audit checklist), with the records they looked at and what they looked for in the records. Unfortunately, if you never created an Essential Requirements Checklist (ERC) before, you can only write in your audit notes that the checklist was completed and what the revision date is. How would you know if the ERC was completed properly?

In addition to the ERC, now called the Essential Performance and Safety Requirements (i.e., Annex I of new EU regulations), you also need to audit all the Technical Documentation requirements (i.e, Annex II), all the Technical Documentation on Post-Market Surveillance (i.e., Annex III), and the Declaration of Conformity (i.e., Annex IV). These four annexes are 19 pages long. If you try to copy-and-paste each section into an audit checklist, you will have a 25-page checklist with more than 400 things to check. The end result will be a bunch of check boxes marked “Yes” and your audit will add no value.

Audits are just samples

Every auditor is trained that audits are just samples. You can’t review 100% of the records during an audit. You can only sample the records as a “spot check.” The average technical file is more than 1,000 pages long, and most medical device manufacturers have multiple technical files. A small company might have four technical files. A medium-size company might have 20 technical files, and a large device company might have over 100 files. (…and you thought the 177-page regulation was long.)

Instead of checking a lot of boxes “Yes,” you should be looking for specific things in the records you audit. You also need a plan for what records to audit. Your plan should focus on the most important records and any problem areas that were identified during previous audits. You should always start with a list of the previous problem areas, because there should be corrective actions that were implemented and effectiveness of corrective actions needs to be verified.

Which records are most important when auditing technical files?

I recommend selecting 5-7 records to sample. My choices would be: 1) the ERC checklist, 2) the Declaration of Conformity, 3) labeling, 4) the risk management file, 5) the clinical evaluation report, and 6) post-market surveillance reports, and 7) design verification and validation testing for the most recent design changes. You could argue that my choices are arbitrary, but an auditor can always ask the person they are planning to audit if these records would be the records that the company is most concerned about. If the person has other suggestions, you can change which records you sample. However, you should try not to sample the same records every year. Try mixing it up each year by dropping the records that looked great the previous year, and adding a few new records to your list this year.

What to look for when auditing technical files

The first thing to look for when you audit records: has the record been updated as required? Some records have a required frequency for updating, while other records only need to be updated when there is a change. If the record is more than 3 years old, it is probably out of date. For clinical evaluation reports and post-market surveillance reports, the new EU regulations require updating these reports annually for implantable devices. For lower risk devices, these reports should be updated every other year or once every three years at a minimum.

Design verification and design validation reports typically only require revisions when a design change is made, but a device seldom goes three years without a single change–especially devices containing software. However, any EO sterilized product requires re-validation of the EO sterilization process at least once every two years. You also need to consider any process changes, supplier changes, labeling changes and changes to any applicable harmonized standards.

Finally, if there have been any complaints or adverse events, then the risk management file probably required updates to reflect new information related to the risk analysis.

Which record should you audit first?

The ERC, or Essential Performance and Safety Requirements checklist, is the record you should audit first. First, you should verify that the checklist is organized for the most current regulations. If the general requirements end with section 6a, then the checklist has not been updated from the MDD to the new regulations–which contains 9 sections in the general requirements. Second, you should make sure that the harmonized standards listed are the most current versions of standards. Third, you should make sure that the most current verification and validation reports are listed–rather than an obsolete report.

How to learn more…

If you want to learn more about how to audit technical files, please register for our webinar on auditing technical files–August 8th @ Noon EDT. We also provide a new audit report template specifically written for your next technical file audit.

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Color change is only device modification. Is a new 510k required?

This article explains the process for determining if a color change and other material changes require a new 510k prior to implementing the change.

color change Color change is only device modification. Is a new 510k required?

I recently taught a frequently asked questions (FAQs) webinar where I asked attendees to provide questions in advance of the webinar and I answered the questions during the webinar. One of the attendees asked how to know if a new 510k is required if the only modification to a device is a color change.

New FDA guidance for device modifications

On August 8, 2016 the FDA released a new draft guidance document for device manufacturers regarding device modifications and when a new 510k is required. The current final guidance is titled “Deciding when to submit a 510(k) for a change to an existing device,” and that guidance is dated January 10, 1997. A draft guidance document on this topic was released in several years ago, but that draft guidance was withdrawn in response to feedback from industry. The new draft guidance document includes modified decision trees to help manufacturers decide which types of changes will require a new submission, but there are also examples provided in Appendix A. The most helpful part of the guidance, however, is Appendix B. Appendix B explains how to document changes properly—regardless of whether a change requires a submission or not.

Decision Trees from the Guidance

There are five decision trees or flow charts provided in the new draft guidance. The purpose of each decision tree is identified below:

  • Main flow chart
  • Decision Tree A = labeling changes
  • Decision Tree B = technology, engineering and performance changes
  • Decision Tree C = material changes
  • Decision Tree D = IVD product changes

How to apply Decision Tree C to a color change

Typically adding a colorant, or changing a colorant, does not negatively impact strength of a device but this is the first cautionary statement made at the beginning of the section for material changes. Therefore, if your device has an performance testing requirements that involve a component that is involved in a proposed color change, then you need to repeat the performance testing to verify that the strength has not been negatively impacted by the color change. Sometimes large concentrations of colorant result in weakening of plastics. Therefore, repeating some of the performance testing or providing data that supports the need for no further testing is expected. In the decision tree this is addressed by question C5, “Could the change affect performance specifications?” If no, then you document the change but a new 510k is not required. If yes, then you refer to decision tree question B5.

The next concern addressed by Decision Tree C is the biocompatibility of your modified device. If the material change of the device or device component comes into direct contact with the body, blood or tissues then biocompatibility risks must be assessed. If the change does create new or increased issues related to biocompatibility then question C4.1 asks, “Has the manufacturer used the same material in a similar legally marketed device?” If the changed material has not been used previously for a similar application, then a new 510k is required—typically a Special 510k if only the material is changed and only biocompatibility needs to be assessed by the FDA.

Reference to FDA biocompatibility guidance

Within the guidance document, the FDA explains that you may want to refer to “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’” when you are answering question C4. This new final guidance was released on June 16, 2016 and the Office of Device Evaluation (ODE) appears to be focusing much more closely on biocompatibility since this new guidance released.

Examples of material changes from FDA guidance

There are six examples of material changes presented in the new draft guidance:

  1. Slight change in polymer composition for a catheter = letter to file
  2. Change in polymer for a catheter
    1. Change in a polymer for a catheter to a polymer already used by another manufacturer for a 510k cleared device with the same indications = new 510k submission
    2. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type and duration of contact = letter to file
    3. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type but shorter duration of contact = new 510k submission
    4. Change in a polymer for a catheter to a polymer already used by your company for another 510k cleared catheter of the same type but longer duration of contact = letter to file
  3. Change in manufacturing method of catheter tubing (i.e., molding to extrusion) = new 510k submission
  4. Change in material for a catheter
    1. New polymer is already used by your company for another 510k cleared catheter of the same type and same duration, but the sterilization method changes (i.e., gamma to EO) = new 510k submission
    2. New polymer is already used by your company for another 510k cleared catheter of the same type, duration, method of manufacturing (i.e., molding) and method of sterilization (i.e., EO) = letter to file
    3. New polymer is already used by your company for another 510k cleared catheter of the same type, duration, method of manufacturing and sterilization, but the performance specifications are slightly different = letter to file (depends upon impact of difference)
  5. Change in dental implant from untreated surface to acid-etched = new 510k submission (may also be considered a design change)
  6. Implantable device is marked temporarily with tape proven not to leave a residue = letter to file

Do you have other questions about biocompatibility?

On Thursday, December 1 @ 11:00am EST I will be hosting a new live webinar on the topic of biocompatibility. The webinar will address both requirements for 510k submissions and for CE Marking technical files. If you are interested in registering for that webinar, please click on the following link:

Click Here for Biocompatibility Webinar 300x64 Color change is only device modification. Is a new 510k required?

Do you have a question about your 510k submission?

If you have a question related to your 510k submission, you can submit your question to me and download the webinar recording for free by clicking on the following link:

Click Here for 510k FAQs Webinar 300x64 Color change is only device modification. Is a new 510k required?

 

I will respond your question by email, but most questions make great future blog topics—like this one.

You might also be interested in our 510k course series:

Click Here for 510k Course 300x64 Color change is only device modification. Is a new 510k required?

You gain unlimited access to 24 webinars related to 510k submission.

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What are the most common FDA Form 483s inspection observations?

I recently had a couple of clients request a quotation for training on best practices for creating a design history file (DHF). Typically the most experienced quality managers request this training, even when they personally know a lot about design controls, because they know that the FDA issues a lot of FDA Form 483s against this requirement.

The most frequent category of FDA Form 483 inspection observation is design controls (i.e., 21 CFR 820.30). There are 10 different sections of the design controls requirement. Manufacturers that do not have design controls in place will frequently receive multiple observation findings during the same inspection–all related to design controls. The most common design control observations are:

  1. A procedure for design and development has not been established in accordance with 21 CFR 820.30a
  2. A procedure for design transfer has not been established in accordance with 21 CFR 820.30h
  3. A procedure for design changes has not been established in accordance with 21 CFR 820.30i
  4. A design history file (DHF) has not been established in accordance with 21 CFR 820.30j

Therefore, if a manufacturer has no procedure for design controls, then the manufacturer could receive 4 different observations on FDA Form 483.

ISO 13485:2016 Requirements

On March 1, 2016 the 2016 version of ISO 13485 was released. The new version of the Standard now requires procedures for design transfer, design changes and design and development files in an effort to be harmonized further with US regulatory requirements. Therefore, this presentation was created to specifically identify changes needed to your design controls procedure in order to comply with the latest version of the Standard.​​​​​​​

Design History File (DHF) Webinar

You can register for this live training webinar on April 14. For a cost of $129 you will receive:

  • a link to join the live webinar @ 10am EDT
  • a native slide deck for the new live webinar
  • a link to download a recording of the live webinar

This live webinar explains what needs to be included in your procedures for design and development, but the webinar explains how and when to create a design history file (DHF). After you create a procedure, you can show the recording of this webinar to your design and development team to ensure that design and development documentation is compliant and updates are efficiently maintained.

CLICK HERE to register for the DHF Webinar.

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