July 31, 2014

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others, generally voice support for the UDI concept, while finding lots and lots to say about where the FDA’s September Draft Guidance could use improvement.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

 

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

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.

 

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

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!

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

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.

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

The Much-Anticipated CIP Version 5 Final Rule Released by FERC

Trey Kirkpatrick

Vice President, Energy & Utilities Compliance, AssurX Inc.

At the FERC Commission meeting on November 21, 2013, the Commission approved the CIP version 5 Standards that addresses the cyber security of the bulk electric system.  As stated in the FERC final rule, these standards are an improvement over the current effective CIP version 3 Standards.  CIP version 5 requires the industry to adopt new controls and expands the scope of systems that are protected by the CIP standards.  The Commission also approved definitions associated with the CIP Standards and directed NERC to make modifications to CIP version 5 and submit informational filings back to FERC.

FERC LogoOne of the key decisions, as requested by the ERO, was the Commission’s approval to allow registered entities to transition from currently-effective CIP version 3 Standards to compliance with CIP version 5 Standards.  The CIP version 4 approved Standards will not become effective.  CIP version 3 will remain in effect until the effective date of CIP version 5.  The Commission also approved the implementation plan and effective dates proposed by NERC.

Some of the key highlights from the FERC Order:

  • The CIP version 5 Standards identify and categorize BES Cyber Systems using a new methodology based on whether a BES Cyber System has a Low, Medium, or High Impact on the reliable operation of the bulk electric system. At a minimum, a BES Cyber System must be categorized as a Low Impact asset. Once a BES Cyber System is categorized, a responsible entity must comply with the associated requirements of the CIP version 5 Standards that apply to the impact category.
  • The CIP version 5 Standards also include 12 requirements with new cyber security controls, which address Electronic Security Perimeters (CIP-005-5), Systems Security Management (CIP-007-5), Incident Reporting and Response Planning (CIP-008-5), Recovery Plans for BES Cyber Systems (CIP-009-5), and Configuration Change Management and Vulnerability Assessments (CIP-010-1).
  • The Commission directs NERC to remove language found in 17 requirements in the CIP version 5 Standards that requires responsible entities to implement the requirements in a manner to “identify, assess, and correct” deficiencies.   We support NERC’s move away from a “zero tolerance” approach to compliance, the development of strong internal controls by responsible entities, and NERC’s development of standards that focus on the activities that have the greatest impact on Bulk-Power System reliability. However, the Commission is concerned that the proposed language is overly-vague, lacking basic definition and guidance that is needed, for example, to distinguish a successful internal control program from one that is inadequate.

Note the Commission response to the “identify, assess, and correct”

“We would prefer approaches that would not involve the placement of compliance language within the text of the Reliability Standards to address these issues. We understand that NERC has inserted the “identify, assess, and correct” language into the CIP Reliability Standard requirements to move its compliance processes towards a more risk-based model. With this objective in mind, we believe that a more appropriate balance might be struck to address the underlying concerns by developing compliance and enforcement processes that would grant NERC and the Regional Entities the ability to decline to pursue low risk violations of the Reliability Standards. Striking this balance could be accomplished through a modification to the Compliance Monitoring and Enforcement Program. We believe that such an approach would: (1) empower NERC and the Regional Entities to implement risk-based compliance monitoring techniques that avoid zero defect enforcement when appropriate; (2) allow the Commission to retain oversight over the enforcement of Reliability Standards; and (3) ensure that all Reliability Standards are drafted to be sufficiently clear and enforceable.”

  • The Commission directs NERC to develop modifications that address security controls for Low Impact assets. The adoption of the Low Impact BES Cyber Asset category will expand the protections offered by the CIP version 5 Standards to additional assets that could cause cyber security risks to the bulk electric system. Specifically, categorizing BES Cyber Systems based on their Low, Medium, or High Impact on the reliable operation of the bulk electric system, with all BES Cyber Systems being categorized as at least Low Impact, offers more comprehensive protection of the bulk electric system. However, the CIP version 5 Standards do not require specific controls for Low Impact assets nor do they contain objective criteria from which to judge the sufficiency of the controls ultimately adopted by responsible entities for Low Impact assets. The Commission directs that NERC develop modifications to the CIP version 5 Standards to address this concern. While NERC may address this concern by developing specific controls for Low Impact facilities, it has the flexibility to address it through other means, including those discussed below.
  • The Commission directs NERC to submit an informational filing one year from the effective date of this Final Rule that assesses, based on the survey results, whether the BES Cyber Asset definition will, with the 15- minute parameter, cover the assets that are necessary to ensure the reliable operation of the Bulk-Power System.
  • Commission directs NERC to create a definition of communication networks and to develop new or modified Reliability Standards that address the protection of communication networks.  The Commission also directs its staff to include the issue of protecting the nonprogrammable components of communications networks in the staff-led technical conference discussed herein.

For more information: 

NERC CIP Version 5 Implementation Plan

Version 5 Critical Infrastructure Protection Reliability Standards, Docket No. RM13-5-000

Commissioner LaFleur’s comments

Trey Kirkpatrick is Vice President of Energy and Utilities for AssurX, Inc., a leading provider of energy and utility enterprise compliance management solutions.

 

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

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.

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

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

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

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?

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

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.

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare

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.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare