April 18, 2014

FDA VCIP Program: Too Much Stick, Not Enough Carrot?

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s a growing trend in these United States: paying extra for convenience such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine for-pay express lanes.

Where I live in the Washington, D.C. area, the new express road program in Northern Virginia’s clotted traffic arteries appears to be a hit. For a buck or two, you get out of the more crowded free lanes. And you are allowed to go 65 miles an hour, while the peasants are held to 55 mph!

On the other hand, the express lane program at Reagan National Airport doesn’t appear to be generating much traffic.

If the FDA’s new VCIP (Voluntary Compliance Improvement Program) is trying to ride the “pay for convenience” bandwagon, early anecdotal evidence suggests they’re resembling airports more than highways. We’re hearing many in industry say the VCIP program doesn’t offer enough of an incentive to take on the extra work.

Undaunted, FDA released earlier this week a document that reads like a nice, bureaucrat gently trying to convince industry to give the program a try.

The joint pilot project housed in the Center for Devices and Radiological health (CDRH) and Office of Regulatory Affairs (ORA) “differs from the FDA’s traditional oversight model by allowing firms to voluntarily self identify and correct possible regulatory violations instead of undergoing FDA inspection.”

Regulated entities have to apply to participate, but those with violations that raise “imminent” public health concerns needn’t bother.

Here’s the FDA’s big carrot: “The FDA supports using new approaches to help companies come into compliance. These approaches benefit industry and may decrease the number of inspections that the FDA performs or permit the agency to focus on manufacturers with serious and ongoing problems.”

Pacemaker150Hmm. I guess I’m not super surprised that initial industry enthusiasm appears weak. To my knowledge, FDA has not released any statistics about participation. I’m basing my very early days’ assessment on discussions with medical device firms and consultants at recent trade shows and the like. I could be wrong, and VCIP might turn out to be a big hit.

If you want to get picked, know that FDA will identify manufacturers eligible to participate in VCIP through its 2014 inspection work plan and offer them an opportunity to apply rather. For the pilot, the FDA will choose three to five applicants. Of course, their feedback, whether official or in trade show hallway conversations, will tell us a lot about the merits of VCIP.

While it promises some benefits down the road, initial participation in VCIP sounds like it will just add another layer to a device manufacturer’s compliance program. VCIP participants will be required to retain an outside expert consultant to assess their manufacturing and quality assurance systems and to monitor and certify that they are following program requirements. Firms must also demonstrate the ability to define problems, analyze root causes, create appropriate corrective actions, and verify that the actions taken were effective.

If a firm does not meet its commitments under the VCIP, or if the FDA and the firm disagree about any of the results, then the firm may be removed from the program and undergo FDA inspection, which could lead to regulatory action. If a manufacturer ends its participation in the VCIP, it would be subject to FDA inspection and any resulting regulatory action.

FDA gets to the potentially big benefits toward the end of the new VCIP document. If you are selected and pass the tests, your firm “will not be subject to routine surveillance inspection while program participation is underway.” The exemption will be good for two years after a manufacturer successfully completes the program. FDA says it will also expedite review of export certificate requests and prioritize device and pre-amendment determination requests from program participants.

Clearly it’s too early to judge whether VCIP will be a success. And FDA is to be applauded, I think, for trying something a bit new.

Still, here’s hoping VCIP becomes the equivalent of sailing down the relatively empty highway at 65 mph, while others are slogging through heavy traffic at lower speeds.

 

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FDA Draft Medical Device Development Tools Guidance is Here to Help

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

A new FDA draft guidance just issued by the Center for Devices and Diagnostic Health (CDRH), outlining a voluntary process for qualification of medical device development tools (MDDT), is designed to facilitate the development and “timely evaluation of innovative” medical devices, the Center says.

An MDDT is a scientifically validated tool — such as a clinical outcome assessment or a test to detect or measure a biomarker — designed to aid device development and regulatory evaluation.

The guidance, issued November 14, 2013, describes the framework and process of voluntary CDRH qualification of MDDT.

It also includes a helpful definition of key concepts that provide something of a window into FDA’s viewpoint and regulatory expectations. Here are two important examples of how FDA views the world:

  • Qualification: A conclusion that within a specified context of use (FDA’s italics), CDRH expects that the results of an assessment that uses MDDT can be relied upon to support device development and regulatory-decision making.
  • Context of Use: Use defined in part by the device or product area for which the MDDT is qualified, the stage of device development, and the specific role of the MDDT.

FDAlogoCDRH is developing a qualification process because it provides a mechanism for leveraging advances in regulatory science, encouraging MDDT development and adoption, and “facilitating faster, more efficient device development and regulatory evaluation,” the draft guidance states.

However, the guidance intentionally stays away from any specific evidentiary or performance expectations the agency would have for qualifying a specific MDDT.

FDA is accepting comment and suggestions for revising the guidance until early February 2014. Electronic comments should be sent to http://www.regulations.gov.

 

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FDA: Get Ready, the World is Getting Ready to Change

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

This headline statement was shared by Michael Fauntleroy, FDA’s ESG Program Manager, during last week’s RAPS 2013 conference. It was in relation to his opinion that all FDA submissions in the future will require to be electronic. Mr. Fauntleroy also states that all adverse events for medical devices will require submitters to use the agency’s ESG (Electronic Submissions Gateway) by 2015. Furthermore, he expects that all adverse events for individualized commercial products submissions to be mandated by 2017.

However, the industry is already utilizing the technology as Mr. Fauntleroy noted: already this year the ESG has received over 4.5 million transactions in total, with over 1.1 million to the CDRH.

It is obvious that the ESG is FDA’s “go to” technology for its connection to the world when it comes to incoming submissions, their acknowledgements, and routing for processing. We have seen this focus on the ESG in numerous other ways recently. As announced by the FDA two weeks ago, the UDI (Unique Device Identifier) database termed “GUDID” will be populated via submissions that are handled through the ESG. Furthermore, as reported last week by Mr. Fauntleroy, a partnership between FDA and Canada Health utilizes the ESG to help standardize the submission process for both countries, and routes submissions accordingly. This allows medical device companies to send their submissions to one location (with the same set of requirements, and typically no additional programming for the submitter) and the submissions route to the desired country’s health organization for acknowledgement and processing.

 

eMDR

AssurX eMDR Process

AssurX worked in close coordination with the FDA over the years as we developed our AssurX eMDR solution that utilizes the FDA’s ESG for electronic submissions. In fact, Mr. Fauntleroy noted how prevalent AssurX customers are in utilizing this technology as he continues to see more and more AssurX accounts requesting access and others actively utilizing the ESG with their eMDR submissions. We are truly happy that the solution we have provided to our customers has been used and accepted so favorably by the industry. We look forward to the continued use of our software with the ESG technology for other regulatory submission needs in the future.

Click here for more information in AssurX’s turnkey eMDR solution which communicates directly with FDA’s Electronic Submissions Gateway

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FDA Looks Overseas, Doesn’t Like What it Sees

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Thanks to the folks in Washington, most anything having to do with the federal government is closed until further notice. That means fixtures like the Grand Canyon and the Library of Congress (LOC) are off-limits.

The FDA is feeling the pinch too. It’s had to send about half of its staff home, according to RAPS. FDA’s website won’t be updated, either.

The lion’s share of the pre-shutdown device-related warning letters involved overseas entities. A good example comes in a September 5, 2013 letter to Vincent Medical Manufacturing Company, based in Dong Guan City, China.

FDA kicked the tires at this manufacturer of breathing circuits and sterile fluid management injection systems, and didn’t like some of what it saw. For example, Vincent’s Corrective and Prevention Action (CAPA) failed to establish and maintain a number of procedures.  Vincent was also charged with failing to ensure that inspection and test procedures could be validated with a “high degree of assurance.”

FDA also chided Vincent for “failure to establish and maintain procedures to ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed.”

FDAlogoFDA sent an August 26 letter to Bio Focus Co., based in Uiwang, Republic of South Korea.  FDA hit that firm for an inadequate CAPA program, process validation, device design validation, management of suppliers and other outside vendors, and environmental controls, among several other issues. Bio Focus manufactures Sure-Aid pregnancy tests.

In Taiwan, FDA challenged St. Shine Optical, manufacturer of contact lenses, for several shortcomings. Shortcomings cited in the August 26 warning letter include: inadequate validation reports, design control procedures, and process controls.

Earlier in August, FDA issued a warning letter to Denmark-based Dako Denmark, manufacturer of the HER2 CISH pharmaDx kit. In the August 21 letter, FDA noted that the firm closed six CAPA’s, but failed to provide any evidence that the CAPA’s were effective.  FDA also hit the firm for inadequate process validation protocol, and complaint processing.

FDA returned to the U.S. with a September 20 letter to Medical Device Resource Corporation. The Livermore, California-based maker of the LS2 Aspirator, and the K Pump was issued a warning letter because it’s process validation, outside products, and other product controls were found lacking.

Elsewhere in California, Medtronic MiniMed was hit with, among others issues, inadequate CAPA, device control, and complaint management. That came in a September 19 warning letter.

While medical device makers may not be overly worried about a hobbled FDA, let’s all agree that it would be nice someday to be allowed to visit the Grand Canyon and the LOC again. Those are both bi-partisan places, right?

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FDA Hopes to Rollout New Adverse Event Reporting Tool in December

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

FDA’s Center for Devices and Radiological Health (CDRH) has finally picked a new adverse event (AE) reporting tool for devices. It’s slated to be in place by the end of the year. Of course, the agency missed a few deadlines to pick a new tool, so that deadline could slip, too.

FDAlogoThe creaky MAUDE, or Manufacturer and User Facility Device Experiences system, is out. It’ll be replaced by a PRIMO internet-based software platform developed by the November Research Group (NRG). FDA just inked a five-year contract with NRG.

While NRG touts its tool as a cut-above commercially available pharmacovigilance solutions primarily focused on generating the reports then sent to regulators, PRIMO is specifically designed for streamlined report intake and high-volume, intelligent report review, according to the company.

NRG’s tool is designed to, among other things, speed AE reporting into CDRH, and generate more accurate follow-up data returning to the device maker from the agency.

Years in the making, the upgrade was part of a concerted CDRH that included the September 2012 release of a white paper, “Strengthening Our National System for Medical Device Postmarket Surveillance.”  The white paper laid out the market conditions demanding an AE reporting system upgrade. It also included four specific calls to action:

  1. Establish a Unique Device Identification System and Promote Its Incorporation into Electronic Health Information;
  2. Promote the Development of National and International Device Registries for Selected Products;
  3. Modernize Adverse Event Reporting and Analysis; and,
  4. Develop and Use New Methods for Evidence Generation, Synthesis and Appraisal.

CDRH has said in the past that it receives more than a thousand AE’s each day.

NRG unveiled the new tool back in March.

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Unique Device Identifier (UDI) Rule Now a Reality for Manufacturers

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

On Friday morning, September 20, 2013, at the UDI User Conference in Baltimore, MD, Jay Crowley, FDA’s Senior Advisor for patient safety, CDRH, raised a glass to toast the completion of a decade long journey. He, his staff and members from the Medical Device industry and solution providers celebrated the announcement of the publishing of the Final Rule for the establishment of the Unique Device Identification system. The final rule will be officially published Sept 24, 2013 on the U.S. Federal Register.

That date is an important one as it establishes the start date for the timeline for all medical devices to be coded with a Unique Device Identifier (“UDI”), which is to be printed in plain text and barcode (or other AIDC technology) on the device’s label. Manufacturers of Class III medical devices will have one year to comply with the rule. Class II and Class I devices which are used as implants and/or are life supporting/sustaining in nature have 2 years to comply. All other Class II devices must comply within 3 years of the publish date and all Class I and unclassified medical devices must comply within 5 years of the published date, per the Final Rule.

A number of changes were made from the original proposed rule, but one proposed requirement which was hotly debated by industry was the proposed required date format. The original date format on labeling was proposed to be the US-centric “MMM DD, YYYY” format.  However, with the final rule, the requirement has been changed to the more global-friendly (and ISO compliant): YYYY-MM-DD

UDI barcodeFurthermore, this rule institutes a new FDA Global Unique Identification database (or “GUDID”, pronounced “Good ID”), into which all manufacturers (or “labelers” as defined in the rule) must populate their unique Device Identification numbers. This database will also require providing FDA required attribute information. Once populated, the GUDID database will be used by healthcare providers and the public to search for and gain information about the device.

The initial goal of this rule is to be able to better identify devices in the healthcare area, to help healthcare providers identify items in cases of adverse effects/recalls, as well as to better understand and manage their inventory.

AssurX will be working with current and future customers to use our solution to help them comply with their UDI management and eventual submission to FDA’s GUDID database.

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No FDA Guidance or Specific Regulation but Don’t Overlook the Criticality of Product Life Cycle in Medical Device Design Control

Dennis Payton, Executive Director of Product Marketing, Expandable Software, Inc.

Dennis Payton, Executive Director of Product Marketing, Expandable Software, Inc.

After a discussion of the short FDA CFR 21 Part 820 Quality System Sec. 820.30 and Sec. 820.40 on Design Control, even with the expanded FDA ‘Design Control Guidance For Medical Device Manufacturers’, there is not any mention of controlling the device lifecycle as part of the design controls. With the high degree of findings in the Design Control regulation, an important piece not discussed is the state or status of a product and definitions surrounding the Life Cycle of products. An important distinction and critical element of any Design Control fully defining a Product Life Cycle (PLC) and assigning stages of a product through a design process supplies a critical element in any general product management and can play a critical role in Medical Device audit and FDA Design Control compliance. Development of a Product Life Cycle (PLC) along with a solid Product Development Process (PDP), a topic for a later discussion, provide the provide the necessary corner stones for a complete Design Control and Device Management compliance. In this article we’ll explore the basics of a PLC to provide the basics, each manufacturing and development environment may need to adjust the model to meet the needs of the given environment but meshing the PLC with a solid PDP that align and complement each other provide a very solid Design Control base platform.

General Cradle to Grave Product Lifecycle

A simplistic product lifecycle has some very basic phases of life: research, development, production and end of life. These can certainly be expanded as needed by a specific device design & manufacturing complexity, or simplicity for that matter, as well as device class, category and classification. There can be sub-phases in the product development (prototype, engineering build, alpha, beta, archived, etc., level of product status, for example) but the main concern is to define the lifecycle that best meets the overall objective while being able to track the various product and versions of product in development, in the marketing place and archived after manufacture discontinuance (still have to support those products in the market place even though the selling cycle has ended).

The diagram below provides the basic PLC model and a generalized flow of life. A good deal of the life cycle flow should be overlaid with a device development process so while the PLC is discussed here remember that both the PLC and PDP for a given manufacturing environment should be developed in conjunction so that the two mesh well and complement each other as part of the total design control of devices.

Source: Expandable Software

Source: Expandable Software

As a Product Manager each of these phases of a product are of concern. The FDA defines some flexibility is design control as to when those controls should engage somewhere in the gray area between Research and Development mainly in an attempt to loosen up compliance a bit to help encourage research of new technologies and device for the medical industry. While the FDA being somewhat flexible in the front end research, for a Product Manager managing products even in the research phase needs some definition to help define when technology can be developed for the market place and further defined as viable for the business, market and developed into a marketable device. With the remaining PLC, the FDA will certainly want solid design controls and tracking of the device history from development through to product end-of-life (EOL) although for all purposes the EOL of products doesn’t mean that they disappear, rather they are product designs that gets archived for any reason that they might need to be revisited for support of product in the market. Here again the other end of the PLC spectrum may have deeper EOL process depending on the device(s) a manufacture is delivering to the market and how those devices live beyond the final sales.

Key points to consider in the development of a specific product life cycle (PLC) are:

  1. General enough to apply to finished product as well as supply chain components
  2. Define a solid definition between a research phase and development phase that will meet the definitions of controls for a particular product. Note: the FDA can be a bit more flexible with the research phase as far as hard and fast design documentation but best to make sure there is a clear distinction and definition built into a PLC and PDP and assure adequate regulatory coverage
  3. Perform a clear and clean hand off between Development and Production with all associated documentation approved and release. Be sure there is a process built into the PLC to review current product for meeting needs (both marketing and business) and allow for adjustments/changes as the product traverses it lifecycle
  4. Design a process around the End-Of-Life of a product both from a business perspective (not to strand any inventory, leave customers without solutions, etc.) but also from a regulatory perspective in that no product really “ends” – it rather gets archived and stored so that design history is retrievable (very much like Levi’s…they “never die they just fade away” but the history must endure). Note: although the general case of the PDP provided in previous sections has been focused primarily on the R&D and production phases of this PLC, the EOL Process is equally important to define and put in place so that product is properly archived for future reference, retrieval and audit compliance.

This short article can never do full justice to defining a full Product Life Cycle (PLC), there have likely been many books written on the topic, but the key point here is that there is not a whole lot of FDA regulation or guidance for Design Control that discuss PLC. A basic product management tool like a well-defined PLC can play a huge role in compliance to Medical Device Design Control and overlaid with a well-defined Product Development Process can help avoid design control issues, FDA finding or even worse warning letters or other punitive action. From a Product Managers perspective the earlier in the startup device manufacture and earlier in the product life that these principles can be applied the better managed the overall product can be managed both from a compliance perspective and from a business perspective. Regardless of the FDA compliance managing the product from a business perspective can pay big dividends in determinate time to market when managing the PLC married to a well-defined and practiced PDP. These PLC and PDP topics along with a perspective of FDA Design Control normalization and enterprise tools that manage the process and can accelerate time to market are discuss together in an Expandable Software white paper: “Quality System for Startup Medtech Companies: Design & Documentation Controls”.

Get the full detailed White Paper here.

About the Author

Dennis Payton is executive director of product marketing with Expandable Software Inc. He has 23 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State University, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.

 

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New Guidance Offers Clarification on IDE Requirements

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

School bells are sounding the death knell of summer across the land. But, as we’ve noted before, the FDA didn’t take much time off to enjoy surf and sand.

The agency capped a busy season last week by issuing a new guidance aimed at Investigational Review Boards, Clinical Investigators, and Sponsors when determining if an Investigational Device Application (IDE) or an Investigational New Drug Applications (IND) is warranted.

Structured in a helpful Q&A format, the guidance should make it easier for device and drug companies and other entities to understand what’s expected of them in this often gray area.

For example, the guidance reaffirms that an IRB must review the qualifications of clinical investigators who conduct FDA-regulated research.

However, the agency does illustrate some situations where there is interpretive leeway for regulated entities. “In many cases, the IRB may have previous experience with an investigator or institution that would allow the IRB to readily determine that the clinical investigator is appropriately qualified to conduct and supervise the proposed research.” If that’s the case, you’re probably okay to get started.

The guidance also reminds us clinical investigator report cards are available on the FDA website. IRBs may check the lists posted on FDA’s website to determine whether a clinical investigator has been the subject of an inspection by the agency and the results of such inspections (e.g.,Warning Letters). FDA also posts on its website a listing of all investigators who have been notified of the initiation of a disqualification proceeding or have been disqualified.

FDAlogoThe guidance also spells out the requirements to determine whether submission of an IDE application to FDA is required. That determination is based, in part, on assessing the risk factor for the device. The IDE regulations (21 CFR 812) describe three types of device studies: significant risk (SR), nonsignificant risk (NSR).

The sponsor is responsible for making the initial risk determination, and presenting it to the IRB. If the sponsor has determined that a device study is NSR, the IRB must review the sponsor’s determination. If the IRB disagrees with the sponsor’s NSR assessment and decides the study is SR, the IRB must inform the clinical investigator and, where appropriate, the sponsor. The IRB should also document its SR/NSR determination in the IRB meeting minutes.

FDA can assist sponsors, investigators, and IRBs in making the determinations. Information on how to get started can be found in the agency’s 2011 guidance Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices.

FDA’s lists of investigators it has examined can be found here:

 

 

 

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FDA Wants Your Patient Preference Input for Medical Device Regulatory Processes

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

After a surprisingly busy summer, the FDA is leaping into September with a two-day meeting where you can be the star — or on the defensive.

Mark your calendar for Sept. 18-19 at FDA headquarters in Rockville, MD for “The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes.”

FDA’s goal is to open a dialogue on the best ways to incorporate patient preferences on the benefit-risk tradeoffs of medical devices into the full spectrum of the Center for Devices and Radiological Health (CDRH) regulatory decision making.

It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers. The agency intends to use information gleaned from the workshop and subsequent public comments to help regulators, industry, providers, patients, and device innovators to get on the same page.

FDAlogoMeantime, FDA’s busy summer included a slew of new warning letters. In Taiwan, Soleetech Corporation, a manufacturer airway (extension) connectors, flat out told the FDA it didn’t have, and didn’t plan to develop, any kind of Corrective and Preventative Action (CAPA).

I understand that different nations have different cultural quirks, but telling the FDA you aren’t much interested in CAPA is a universally bad idea.

August was indeed a busy warning letter month. As of August 22, more than dozen had already been issued. And with the month not over, and a lag time in posting some letters, August is shaping up to be a big enforcement month.

Nearly half of August’s warning letters zeroed in on Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) alleged shortcomings. Typical of this trend was an August 8 letter to Healing Dives Inc.

So, as we all drive back from the beach, it’s time to examine FDA’s next moves. Look for an upcoming post from fellow blogger and former FDA inspector Patrick Stone with his wish list for what he views as the FDA’s most burning issues in September and beyond.

 

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FDA Warning Letters Emphasize CAPA, Design Issues

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA focused its regulatory laser beam on the Midwest and overseas in the latest wave of medical device warning letters.

Enraf-Nonius B.V., a device maker based in the Netherlands but doing business in the U.S., was hit in several areas, including:

Failure establish and maintain device controls in relation to acceptable validation during a clinical trial, failure to set up procedures to determine whether device changes require validation or verification, and failure to document post-production design changes.

As is so often the case in FDA warning letters, CAPA again reared its head. In the July 5 letter, the device maker was charged with several alleged CAPA shortcomings. These include failure to establish a process that makes certain corrective actions are noted and take steps to prevent the issue from happening again, and failure to address illegible, missing and/or incorrect component codes.

Back here at home, Pennsylvania-based firm Lenfest Media Group was advised in a July 1 letter that its product claims lack FDA clearance or approval. Lenfest markets its WaxVec that it claims “gently draws dirt particles and moisture out of your ear quickly and safely.

warning640In Ohio, x-ray systems-manufacturer Meridian Medical Systems was hit with CAPA violations, and alleged design history violations, including:

  • A design plan for the project
  • Established or approved design inputs/outputs for the system
  • Verification or validation testing for the system
  • Design transfer
  • Risk management for the system
  • Design reviews

The firm was also warned for allegedly not having a handle on its suppliers, an issue that the FDA appears to be focusing on more and more. It could be, in part, because more and more domestic firms and outsourcing device manufacturing work overseas.

Completing our latest round-up, we travel to Turkey, where FDA issued a June 27 warning letter to Aygun Cerrahi Aletler A.S. Surgical Instruments Co., with charges of CAPA shortcomings and several other issues, including failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, and failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

 

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