September 2, 2014

CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate

Tamar June

Tamar June, VP, Strategic Marketing, AssurX, Inc.

The Center for Devices and Radiological Health (CDRH) will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014-2015 Strategic Priorities report released Feb. 5.

To help encourage that innovation, CDRH says it’s going to work to improve the consistency of the Investigational Device Exemption (IDE) process, especially in the areas of consistency and speed with which it handles applications. CDRH also pledges to find ways to encourage more early IDE studies — especially for those with medical devices aimed at the U.S. patient marketplace.

The report also says CDRH will try to find a better balance between premarket and postmarket data requirements.

CDRH sets measurable metric goals for improving IDE cycles:

  • By September 30, 2014, reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 25 percent compared to FY 2013 performance.
  • By September 30, 2014, for disapproved IDEs, offer all sponsors a teleconference or in-person meeting to occur within 10 business days of the IDE decision.
  • By June 30, 2015, reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 50 percent compared to FY 2013 performance.

Time to IDE Approval:

  • By September 30, 2014, reduce the overall median time to appropriate full IDE approval by 25 percent compared to FY 2013 performance.
  • By June 30, 2015, reduce the overall median time to full appropriate IDE approval to 30 days.
  • In FY 2013 (as of 12/11/2013), 45% of IDEs received a full approval decision within 2 cycles and median time to full IDE approval was 174 days.

2014 ClockBy June 30, 2015, the report says CDRH intends to increase the number of early feasibility/first-in-human IDE studies submitted to each premarket division compared to FY 2013 performance. CDRH promises several action steps here, including:

  • Establish in the Office of Device Evaluation a premarket clinical trials program responsible for the oversight and performance of the IDE Program and the development and implementation of policies that contribute to the timely initiation and successful execution of medical device clinical trials.
  • Formalize the incorporation of our benefit-risk framework, including patient-specific factors such as tolerance for risk and perspective on benefit, into the IDE process.
  • Establish a process to efficiently and objectively resolve application-specific IDE issues to reduce the number of multi-cycle IDEs.
  • Develop a clinical trials education and training program for CDRH review staff, managers, and industry.
  • Develop real-time metrics to track CDRH and industry IDE and clinical trial performance.

Turning to premarket and postmarket data requirements, the CDRH call to arms lays down more goals:

  • By December 31, 2014, review 50 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.
  • By June 30, 2015, review 75 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.
  • By December 31, 2015, review 100 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.

CDRH plans several specific actions to help attain those targets, including:

  • Develop and seek public comment on a framework for when it is appropriate to shift premarket data collection to the postmarket setting.
  • Conduct a retrospective review of all PMA device types to determine whether or not to shift some premarket data requirements to the postmarket setting or to down classify device types in light of our current understanding of the technology.
  • Implement a mechanism to prospectively assure the appropriate balance of premarket and postmarket data requirements for new devices subject to a PMA.
  • Using existing authorities, develop and seek public comment on a new pathway to market for devices subject to a PMA that address an unmet public health need by shifting appropriate premarket data needs to the postmarket setting and incorporating features of the Innovation Pathway pilots.

The medical device industry no doubt applauds the majority of these goals. Now it’s time for CDRH to roll up its sleeves and get them done.

 

 

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Medical Device Industry Identifies Some Problems with Agency’s UDI Initiative

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea.

It gets a little trickier after that.

In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, and Merck, among more than a dozen others, generally voice support for the UDI concept, while finding lots and lots to say about where the FDA’s September Draft Guidance could use improvement.

Noting that implementing UDI will be a “costly proposition,” AdvaMed stresses that the length and complexity of the implementation plan demands a “living document” approach that will allow industry and the FDA to update and improve the guidance as both sides learn more during set-up. AdvaMed follows with 61 specific comments, with suggested changes.

Coviden, manufacturer of medical devices and medical supplies, echoes AdvaMed’s comments, and tosses another 22 into the mix, including a request that the guidance remain open for feedback and comment until the September 24, 2014 implementation deadline.

Merck, among other commenters, requested clarification and summarization regarding the scope of products for which data must be submitted to the Global Unique Identification Database (GUDID). Merck also asked FDA to add information regarding deadlines for submitting data to GUDID.

X-ray of hipBoston Scientific, noting that its medical devices already bear unique identification via HIBCC or GS1 standards, calls FDA out for what it labels “inconsistencies” with the FDA UDI Rule.

To pick one of their examples, and joining several other commenters in making this point, Boston Scientific claims the data elements column “Required?” is unclear because it fails to clarify if it is required to follow the rule based on regulatory requirements or validation requirements. “The meaning of ‘required’ should be clarified so that BOTH regulatory and system validation requirements are clearly identified in this guidance.”

FDA’s got its work cut out for it here, particularly with the recent departure of its UDI guru, Jay Crowley, for the greener fields of consultantdom.

We can offer some small consolation though: Crowley leads a webinar on UDI implementation from his new professional perch. Information is here:

 

Final UDI rule as published in Federal Register

FDA’s UDI page

Previous AssurX blog on UDI

The entire comment letter line-up is available here

 

 

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Interpreting the FDA View of Medical Device Design Controls

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Some of the shortest descriptions in the FDA CFR 21 Part 820 Quality System regulation are found in Sec. 820.30 and Sec. 820.40 totaling about a page of written language around Design Controls and Document Controls. However short, these two sections can be the most complex aspects of Medical Device controls when actual complying with the regulation. Fortunately, the FDA does give a bit more background to help a new medical device company understand these two key elements (see Medical Device Quality Systems Manual, A Small Entity Compliance Guide) but again with the detailed complexities, even those few pages of guidance (covered in section 9 Document and Change Control) fall short of coverage needed to understand the impact a company’s Medical Device Quality System. The good news is that there are some very good tools that can help mitigate these complexities and streamline controls. The bad news is that it still takes a very strong detailed and sustained effort to insure these complex controls are in place for continued success and compliance with regulation.

With a wide variety of Medical Device suppliers there comes a wide variety of processes, procedures and controls that are developed specific to a business and to the Medical Device(s) being produced. It is important to understand how the FDA tries to normalize a specific business to the regulation when auditing that business for Design Control compliance. Having a bit of understanding of their view will help make for a much smoother comparison, analogy and a much cleaner and successful audit of a company’s design processes.

A simplistic model can be derived from the 820.30 regulation that the FDA may use to assure design coverage and compliance of a device design and/or manufacture to the regulation. The design and development model can be graphically depicted and loosely linked to the regulation as follows:

FDA Design and Development Planning Model

Diagraming out the design flow is helpful in seeing a more detailed picture of the flow and validation and verification of a product against its intended use model and specifically important to the FDA that each and every stage of the process is well reviewed and documented.

Again, like the FDA regulation on Design Controls, this is a very short summary of complex processes, document definitions, controls and general management & approvals that there have been volumes of books written. The objective should be to have a very good understanding of how the FDA or other regulatory entity views the medical device controls such that a business can demonstrate how their particular controls map into the regulatory model. A logical analogy of a business’ design and development model should be able to map to the regulatory normalized base line model(s), in doing so, will result in smoother audits with a higher degree of success and hopefully (something the regulatory folks don’t really care about but as a business we all do) a lower expense/time in managing through the audit process.

A fuller descriptive paper outlines some key points in the development of a Medtech-specific design control with a product development process and how to maximize the use of enterprise level business tools that accelerate process, streamline audits and make for a much smoother compliance. The brief outline here is a key element to a more streamlined and smoother compliance with regulation keeping in mind not just the business drivers but also the FDA’s “normalized view” of design controls.

Get the full detailed White Paper here

About the Author

Dennis Payton is Vice President of Product Marketing and Development with Expandable Software Inc. He has 24 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.

 

Copyright UBM Canon. Used by permission.

 

 

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FDA’s 2014 Promises Increased International Operations, Label Enforcement

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly.

With that slightly weasel-like caveat, it’s worth noting three events in 2013 that will almost certainly impact 2014:

1) CDRH’s Office of Compliance Reorganization: With the addition of a Division of International Compliance Operations, watch for the FDA to shift focus and some budget funds to increased inspection and audits of foreign device manufacturers, and increased crackdowns on promotional claims (see below). Steve Silverman, Office of Compliance Director, is making the public relations rounds of late with events at a trade shows and the like. He’s stressing that the new “look” OC will better harmonize and broaden enforcement efforts. We’ll keep an eye on this and report back.

FDAlogo2) Device Off-Label Enforcement: If the old expression “the past is prologue” holds true, device makers would be well advised to take a good hard look at any public claims they, or a surrogate such as a doctor at a trade show, make about the wonderful things its gizmo can or will do for patients. Between May 1, 2012 and April 30, 2013, CDRH averaged two letters per month hitting device makers for making claims outside their 510(l) clearance and making claims requiring additional data they didn’t provide, among other issues. Early anecdotal evidence suggests this trend of more focus and more warning letters will continue to climb in 2014. Again, we’ll keep an eye out.

3) UDI Finally: FDA issued the long-awaited Unique Device Identification (UDI) Final Rule in September. Its driving force and 27 year FDA veteran Jay Crowley, has since left the agency for a consulting gig. It remains to been seen what impact, if any, his departure will have on an issue that’s vexed industry and the agency for many moons. I can’t think Crowley leaving is any kind of net plus in terms of helping to fine-tune the rule. Time will tell. Then we’ll tell you.

I didn’t even factor in the possibility of more budget shenanigans in Washington, D.C. I’m a naive romantic, and I’m not going to go there until I have to.

Happy new year!

 

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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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HighPoint Solutions Announces Quality Partnership with AssurX

HighPoint SolutionsHighPoint Solutions, LLC, a premier, global provider of specialized IT services dedicated to the life sciences and healthcare industries, and AssurX, Inc., a leading Enterprise Quality Management and Regulatory Compliance Software company, are announcing the formalization of their ongoing strategic partnership.

Vice President of Quality & Compliance, Robert Lorence, said, “HighPoint’s extensive domain experience in Quality Systems and AssurX’s product CATSWeb, a very powerful Quality Management System with Training Management and Document Management “built in”, has resulted in a very robust offering for clients.” Lorence continues, “Working together we will further our ability to bring value, competitive edge, and innovative thinking to our clients in a demanding and ever-changing regulatory environment.”

AssurX has offered clients a turnkey approach to projects coupling the AssurX Professional Services Organization (APSO) for configuration and implementation of the CATSWeb product with HighPoint’s Project Management, Business Analysis and Validation services.

Jeff Mazik, Vice President of Life Science Solutions at AssurX said, “The partnership between AssurX and HighPoint allows both our companies to better serve our current and future customers. HighPoint can help their customers identify a best of breed Quality Management solution that consistently meets the customer’s particular business needs and regulatory requirements. At the same time, AssurX is able to complement its Professional Services offerings to its customers with specialized assistance in terms of validation resources and professional project management to Life Science companies located all over the world.”

About HighPoint Solutions
HighPoint Solutions is a premier, global provider of specialized IT with vertically-focused business consulting, system integration, professional service, and managed hosting solutions for life sciences and healthcare companies.   Since 2000, our 500+ consultants have provided business consulting and technology solutions that continue to deliver business value and competitive advantage to more than 140 clients globally. For more information about HighPoint Solutions and their upcoming events, please visit http://highpointsolutions.com/

About AssurX, Inc.
AssurX, Inc., provides highly regulated life science organizations with enterprise quality management and regulatory compliance solutions. With a choice of OnDemand (SaaS) or OnPremise (licensed) software delivery options, AssurX’s flexible, all-in-one system automates quality and compliance processes so issues can be centrally managed. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise. For more information, visit http://www.assurx.com.

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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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Former FDA Inspector’s Crystal Ball: Cloudy With a Chance of Inspected Meatballs

Patrick Stone

Patrick Stone, President, TradeStoneQA

The FDA’s “Food Police” will be in full force to secure budget funds for food safety initiatives for FY 2014 as mandated by congress. More than half of the operating funds will be earmarked for food work. International food inspections will surely be a focus area for the coming year. The inspection goals/FTEs will be set low enough for the field staff to meet or exceed expectations. This again will ensure a steady flow of billions for operating costs. In recent years large chunks of the FDA budget were set for new facilities completion and the dreaded infrastructure technology (IT) upgrades which barely seem to keep up with private industry.

Opioid labeling rules newly penned will assist in identifying and tracking legal drugs, however Internet and backstreet sales will continue to plague the market. Insurance fraud is making it easier for mail-order diversion and out right second hand sales of the legally obtained opioids. So until the insurance scams are tapered this effort will only increase operating cost for the opioid manufacturers.

A medical device tax and new user fees will be required for doing business in our domestic market. It seems that every few years the fee structure increases and becomes more complex. Maybe this is part of the reason our health care cost are always going up exponentially. What will they think of next to add to the user fee list?

compounding pharmacyThe agency has issued product specific sterile drug consent decrees and lengthy 483s for cGMP violations across the nation. There are a few sterile drug manufacturers that judging by the 483 wording will be handed consent decrees very soon. These firms are major market shareholders that have had ample time for remediation without compliance. The recalls from these same firms have been persistent all year.

The great 2013 compounding pharmacy blitz and new regulations request for these manufacturers was not so much as shock and even less awe. The faster FDA defines what compounding drug manufacturing is and provides lengthy guidance on how it should not be done in a compounding pharmacy setting, the faster we will see market self-compliance. Compounding pharmacies must recognize themselves as manufacturing entities and adhere to strict USP <797> and 21 CFR 200 standards that are costly.

Compounding pharmacies are the first line of defense when it comes to the drug shortage so they must operate in strict compliance with sterile the drug cGMP systems approach. More patients will have adverse events and possibly die from non-compliant/contaminated compounded sterile drug preparations if the mindset of the manufacturers is not changed. The State board of Pharmacy cannot shield compounders from civil or criminal liability and the FDA may soon have what it needs for implementing jurisdictional authority.

Here’s to an exciting 2014!

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

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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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