FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

Practices: FDA Regulatory

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On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications,” marks a key milestone in FDA’s re-evaluation of the 510(k) program, which the agency initiated in 2009 in response to concerns that the program did not sufficiently assure the safety and effectiveness of devices as well as industry concerns that the program had become unpredictable and opaque.

Below we summarize the key points from the guidance, discuss how FDA responded to criticisms of the draft version of this guidance, and describe further actions that remain to be completed as part of FDA’s 510(k) re-evaluation project.

Key Points from the Guidance

The new guidance is FDA’s first update to the 1986 “blue book” document, “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3.” FDA asserts that it developed the guidance to inform industry and FDA staff about the agency’s “current review practices,” not to “implement significant policy changes.” Key points from the guidance include.

Elimination of split predicates. The guidance states that the use of a “split predicate” is inconsistent with the 510(k) regulatory standard for demonstrating substantial equivalence. A 510(k) uses a “split predicate” when it compares the device that is the subject of the 510(k) (the “new device”) against one predicate device to show sameness of intended use, and a separate predicate device with a different intended use to show similarity of technological characteristics. Although FDA has been taking this position in practice for several years, this is the agency’s first official, final policy statement on this topic.

Designation of a “primary predicate.” Unlike split predicates, FDA will accept multiple predicates in some circumstances. Multiple predicates are commonly relied upon when a 510(k) combines features from two or more previously marketed devices into a single, new device. In the guidance, FDA generally encourages the use of a single predicate to simplify the decision-making process. It also recommends that, when a manufacturer relies upon multiple predicates, the 510(k) identifies the “primary predicate,” which is “the one with indications for use and technological characteristics most similar” to the new device.

Explanation of “reference devices.” The guidance discusses the use of “reference devices,” which, like the term “primary predicate,” does not appear in the statute or FDA regulations. Reference devices are legally marketed devices, other than the predicate device(s), that are referred to in a 510(k) to help support the use of particular scientific methods or reference values. The guidance states that a manufacturer intending to rely upon a reference device should provide a scientific rationale for its use.

Definitions of “intended use” and “indications for use.” FDA has long recognized a distinction between the “intended use” of a new device, which must be the same as the intended use of the predicate device, and the “indications for use” of a device, which may differ to some extent between the new and predicate device. In the guidance, FDA defines “intended use” to mean the “general purpose of the device or its function,” whereas “indications for use” means “the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.” FDA also repeats the point it has made elsewhere that a manufacturer’s intended use for a device can, in some cases, be determined by facts and circumstances outside the 510(k) submission itself. Although these concepts may sound straightforward, identification of the “intended use” of a device can be a matter of negotiation, and in some cases dispute, between manufacturers and FDA.

Determining whether new “indications for use” constitute a different “intended use.” According to the guidance, FDA may find that changes in indications for use constitute a different intended use when they raise a safety or effectiveness issue not raised by the predicate or have the potential to significantly increase a safety or effectiveness concern raised by the predicate. The guidance contains several illustrative examples of how FDA applies this concept. It also asserts that FDA may rely upon publicly available scientific information or FDA knowledge about how a disease progresses to determine whether indications to treat a certain disease or anatomical site constitute a new intended use.

Determining whether differences in technological characteristics raise different questions of safety and effectiveness. Where differences in the technological characteristics of a new device raise different questions of safety and effectiveness, the new device is not substantially equivalent to the predicate. The guidance describes a logic scheme by which FDA identifies the technological characteristics of a device, compares them against those of the predicate device, and then determines whether there are differences in technological characteristics that raise different questions of safety and effectiveness. FDA states that a “different question of safety and effectiveness” is a question “raised by the technological characteristics of the new device that was not applicable to the predicate device, and poses a significant safety or effectiveness concern for the new device.” Similar to the section of the guidance addressing indications for use, this section of the guidance relies largely on illustrative examples.

Performance data requirements. If the new device described in a 510(k) has the same intended use as the predicate and the differences in technological characteristics do not raise new questions of safety and effectiveness, the remaining statutory question is whether the 510(k) contains information deemed necessary by FDA to demonstrate that the new device is “as safe and effective” as the predicate. The guidance does not discuss this statutory standard at this point in the logic scheme, most likely because FDA’s interpretation and application of that standard is discussed in a separate draft guidance issued on July 15, 2014, titled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.” Instead, the guidance discusses how FDA applies the statutory “least burdensome” principles by applying a hierarchy of performance data requests starting with descriptive information only, and then proceeding stepwise to include non-clinical bench testing and biocompatibility data, analytical studies using clinical samples (e.g., for in vitro diagnostic devices), and clinical performance data if required.

Encouraging 510(k) “Summaries” rather than 510(k) “Statements.” FDA regulations require a 510(k) submission to include either a “510(k) Summary” or a “510(k) Statement.” A 510(k) Statement is a certification that the manufacturer will make available all safety and effectiveness information in a cleared 510(k) within 30 days of request by any person, other than permitted redactions for patient privacy and trade secret protection. Because FDA can and does proactively post 510(k) Summaries on its website, which facilitates transparency, the guidance “encourages all submitters to utilize the 510(k) Summary option.”

Encouraging greater transparency in 510(k) Summaries. The guidance states that FDA, in an effort to improve the transparency and predictability of the 510(k) program, intends to verify the completeness of the information a manufacturer submits in a 510(k) Summary. The guidance includes appendices describing the content required to be included in such summaries under FDA regulations, provides guidance on what information and data should be included, and includes a sample 510(k) Summary. In particular, the level of detail FDA is requesting be included with respect to clinical studies may be greater than manufacturers have been accustomed to providing in the past.

Responses to Criticisms of the Draft Guidance

On December 27, 2011, FDA announced the availability of a draft version of the 510(k) guidance and invited public comment. FDA received numerous comments, but ultimately made few significant changes to the guidance document. The principal changes were to:

  • Expand the discussion of the use of predicate devices and the reasons for defining a “primary predicate”;
  • Add examples to several sections to clarify FDA’s decision-making process for finding devices substantially equivalent despite differences in indications for use, technological characteristics, or performance characteristics;
  • Add an appendix with a sample 510(k) Summary to demonstrate that level of detail FDA expects; and
  • Remove sections of the draft addressing Special 510(k)s and Abbreviated 510(k)s, due to the relationship between Special 510(k)s and planned FDA guidance on submitting a new 510(k) for a device modification.

What’s Next?

It appears that criticism of the 510(k) program has abated somewhat since FDA launched its re-evaluation initiative in 2009. Nevertheless, there are concerns that the 510(k) guidance reflects narrowed interpretations of the substantial equivalence standard that should have been subject to notice and comment rulemaking under the Administrative Procedure Act. Whether FDA’s 510(k) policies or individual 510(k) decisions will be subject to more frequent appeals within FDA, or legal challenges in court, remains to be seen.

Although it has now finalized the 510(k) guidance, FDA has yet to complete a number of other important actions relating to the 510(k) program. These include:

  • Issuing new draft guidance on when modifications to a device are significant enough to require a new 510(k), after having been required by Congress to withdraw its previous draft guidance from August 2011 on this subject;
  • Issuing new guidance on Special and Abbreviated 510(k)s; and
  • Considering comments received in response to the recent draft guidance, “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.”

In addition, FDA in the past has stated that it intends to develop new regulations relating to the transfer of ownership of 510(k)s and to develop a public repository of medical device labeling. Ropes & Gray will continue to monitor developments on these proposed initiatives, and other aspects of the 510(k) program.

FDA Releases Guidance On In Vitro Companion Diagnostic Devices

FDA Releases Guidance On In Vitro Companion Diagnostic Devices

FDA

By Nick Otto

The FDA recently released guidance in an effort to define in vitro companion diagnostic devices (IVDs), explain the need for FDA oversight of those devices, and clarify that, in general, those devices and their corresponding therapeutic products should be cleared simultaneously.

According to the FDA guidance, companion diagnostics manufacturers should submit applications to the FDA contemporaneously with drug product submissions to improve chances that both the drug and relied-upon device are approved at the same time.

If the agency determines an IVD companion diagnostic to be essential to the safe and effective use or indication of a novel therapeutic product, the FDA will generally not approve the product or indication if the IVD companion device is not approved or cleared for that indication.

The regulation of companion diagnostics will be risk-based, as with all other medical devices, and the guidance advises sponsors to consult early with the FDA on the best approach for approving the companion diagnostic.

The FDA also “strongly encourages” both the drug and device manufacturers to participate in discussions about their respective products as early as possible during the development process.

This will enable “a more focused and in-depth discussion about the validation of the IVD companion diagnostic device and will aid in planning for a device PMA or 510(k) that is complete and timely,” the guidance notes.

The guidance also adds that if an in vitro diagnostic manufacturer wants to use a currently approved test and begin marketing the product for use as a companion diagnostic, a new premarket submission will be needed. New companion diagnostics that are intended for the same use as an approved or cleared companion device will be reviewed via premarket approval or 510(k) clearance, as appropriate, the guidance notes.

Labeling for drugs that use companion diagnostics should identify a type of FDA-approved or cleared test to use with the treatment. And, because federal regulations require labeling for IVDs to specify the intended use, device-makers must specify the drug for which their diagnostic is intended.

The FDA also recently released guidance addressing key issues in the agency’s clearance program, describing in detail the critical decision points in the 510(k) substantial equivalence review process.

Smith & Nephew Warns on Advanced Wound Management Business

Smith & Nephew Warns on Advanced Wound Management Business

 

By Jana Simmons and Hester Plumridge

LONDON–U.K. medical equipment maker Smith & Nephew PLC (SN.LN) on Friday said it expects its advanced wound management business to grow below the market rate for the full year as it reported a drop in second-quarter profit.

Net profit in the three months ended June 28 fell to $89 million from $129 million in the same period last year. Revenue was slightly higher at $1.2 billion, from $1.1 billion a year earlier.

The company, which specializes in replacement joints, said it remains confident in its overall group outlook for the full year, although advanced wound management is now expected to grow below the market rate.

The group previously said it expects the business to deliver growth above the market rate. It didn’t provide details on the market rate.

Advanced wound management revenue grew to $337 million from $333 million a year earlier, against an estimated global market growth rate of 2%. The unit offers products used to manage wounds such as pressure sores, diabetic foot ulcers and venous leg ulcers.

Smith & Nephew, a relatively small player in the industry, has been the subject of takeover speculation amid increasing consolidation in the health-care sector. In May, acquisitive U.S. company Stryker Corp. ( SYK ) was forced by U.K. takeover rules to say it didn’t intend to make an offer for Smith & Nephew after the company’s shares spiked on takeover rumors.

The “put-up-or-shut-up” rule means that a potential acquirer must state its intentions immediately and act on them within 28 days. In fact, Stryker was still considering its options. It must now wait six months before returning with an offer, unless a rival bidder emerges.

Write to Jana Simmons at jana.simmons@dowjones.com and Hester Plumridge at hjester.plumridge@dowjones.com

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Equinox Medical, LLC. 
Negative Pressure Wound Therapy Pump Company in the USA and Europe. 
American Made NPWT pump dressing kits

How to compare which NPWT pump to buy? Check out this Medela vs Cobaltt Comparison sheet

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Medela Liberty NPWT PUMP vs Cobaltt NPWT pump system
Product Name Cobaltt NPWT Pump Medela Invia Liberty
Price $2780.00 > $4,000.00
Foam dressing Black Foam Dressing Green Foam Dressing
Portable YES YES
Financing options Capital purchase/Available for lease to own Capital purchase/rental
LCD screen YES YES
Therapy mode Continuous and Intermittent Continuous and Intermittent
Additional cost for canister tubing NO YES
Various canister options YES YES
Portable carrying case Yes Yes

 

Equinox support our dealer network and do not sell the end user, like our competitors.   We believe our dealers are our partners and provide support through a variety of offerings. In addition,  we provide black foam,  which is an industry standard, this saves our dealers time in educating their customers.

 

Have you tried the best NPWT rental company in the US

After seeing all the big changes going on the durable medical equipment market. The one that always stand out is MedcoAmerica from Louisiana. This company continue to grow even with all the changes on the Medicare/Medicaid changes in our domestic healthcare. The company specialize on Negative pressure wound therapy pumps, NeutroPhase wound cleansing and Black foam dressing. This company controls the wound care market in the south and taking a big chunk of market share from the market leader.

MedcoAmerica is one of the fastest growing npwt pump rental company in the US. They are looking for a distributors and partners across America. If interested, check out their website at www.medcoamerica.com.

 

MedcoAmerica NPWT Pump Rentals

Have you tried the best NPWT rental company in the US

After seeing all the big changes going on the durable medical equipment market. The one that always stand out is MedcoAmerica from Louisiana. This company continue to grow even with all the changes on the Medicare/Medicaid changes in our domestic healthcare. The company specialize on Negative pressure wound therapy pumps, NeutroPhase wound cleansing and Black foam dressing. This company controls the wound care market in the south and taking a big chunk of market share from the market leader.

MedcoAmerica is one of the fastest growing npwt pump rental company in the US. They are looking for a distributors and partners across America. If interested, check out their website at www.medcoamerica.com.

 

MedcoAmerica NPWT Pump Rentals

Have you tried the best NPWT rental company in the US

After seeing all the big changes going on the durable medical equipment market. The one that always stand out is MedcoAmerica from Louisiana. This company continue to grow even with all the changes on the Medicare/Medicaid changes in our domestic healthcare. The company specialize on Negative pressure wound therapy pumps, NeutroPhase wound cleansing and Black foam dressing. This company controls the wound care market in the south and taking a big chunk of market share from the market leader.

MedcoAmerica is one of the fastest growing npwt pump rental company in the US. They are looking for a distributors and partners across America. If interested, check out their website at www.medcoamerica.com.

 

MedcoAmerica NPWT Pump Rentals

The lightest and portable Cobaltt NPWT pump is now available in the US

I am glad to report that the newest, lightest, and portable Cobaltt negative pressure wound therapy pump is now available in the US. This pump was designed in Germany and by the looks of it its built for a durable use. This particular NPWT pump can be use in the Hospital, acute care, long term care, assisted living and home care setting. The pump comes with a easy to read LCD screen. Cobaltt npwt pump is designed with two npwt therapy modes, continuous and intermittent. Whether the physician prescribed a continuous pressure of 125mmHg or an intermittent of -125mmhg of high pressure for 5 minutes (adjustable) and -80mmHg low pressure for 2 minutes. The caregiver can adjust the pump with such ease.

I love how the pump actually comes with a portable bag for patient you are ambulatory. I see a lot of active patients that need NPWT therapy and they need to be stuck in their rooms while receiving the treatment. They can go out enjoy the world, go hang out with the family at a park, restaurant or wherever they wish to spend their day. The pump is good to go for 24 hours once its fully charge. Imagine, you don’t have to worry about charging the npwt pump while you are out doing your errands. But you only have to charge this Negative pressure wound therapy pump for four hours to be fully charge. Cobaltt also comes with two canister options, 300cc (for low exudate wounds) and 500cc for heavy exudate. In addition, Cobaltt also comes with a NPWT black foam dressing kits, which is a wound care market standard. Majority of the caregivers in healthcare facilities are familiar withe the black foam dressing change protocol which equates to faster implementation of this new NPWT pump in any facility. They already know how to use and put the dressing even without seeing it.

With the Smith and Nephew Renasys Recall happening as of June 2014, many durable medical equipment dealers and NPWT rental companies have been hit dramatically. They have patients that are currently on Renansys NPWT pump and they have to take them off and use a different npwt pump instead. Plus I am not sure if Medicare/Medicaid will continue to reimburse the facility if the renasys npwt pump is on recall. That would be a good question to ask right away. If you are a dealer and looking for a new npwt pump and needs it right away. Give the guys at Equinox Medical a call. They can help you go through this NPWT recall at this time or until Smith and Nephew fixes their problem. This recall and resolutions will usually takes about 120 to 240 days before you get an answer from the FDA after Smith and Nephew submits their 510K adjustments.

negative pressure wound therapy negative pressure wound therapy pump negative pressure wound therapy wound vacuum 300cc npwt pump canister cobaltt cobalt canister pic 3 for website

 

 

Former KCI executive now running another NPWT Pump Company

Spiracur Appoints Chris Fashek as Its New President and CEO

SUNNYVALE, CA, Jul 09, 2014 (Marketwired via COMTEX) — Spiracur, the developer of the only mechanically powered advanced wound care solution that delivers the proven efficacy of Negative Pressure Wound Therapy (NPWT), today announced the appointment of Chris Fashek as president and chief executive officer. With two decades of experience leading health care companies, Fashek will oversee execution of Spiracur’s development and growth strategies as it expands its global presence as a preferred provider of innovative wound healing technologies.

Prior to joining Spiracur, Fashek served as president and vice chairman of Kinetic Concepts, Inc. (KCI) USA, which is the leader in NPWT of the wound care industry. Before joining KCI, he managed businesses in the pharmaceutical and consumer product markets for Sterling Drug, a division of Eastman Kodak in the United States and internationally. Mr. Fashek currently serves as chairman of the Board of Directors for Spiracur, and director of the IDN Summit, the World Craniofacial Foundation, and other commercial and charitable boards. Fashek received his Masters in Business Administration from Fairleigh Dickinson University and a Bachelor of Arts from Upsala College.

“I am very excited to assume this new role at Spiracur at this time, as the company has significant elements in place for expanding its commercial success,” said Fashek. “Spiracur has the opportunity for sizeable growth due to a substantial increase in covered lives including Medicare reimbursement and positive coverage decisions from multiple private payors, as well as being added as an approved product in two of the largest U.S. GPOs. Not only is Spiracur extremely well positioned to enhance wound care treatment for patients who can benefit from NPWT, but this patient population is growing even larger as we announce new product offerings later this year, which expand our technology platform for broader usage,” continued Fashek.

Spiracur is credited with creating a new category of chronic and acute wound management solutions that combine the benefits of advanced wound care with non-powered NPWT. The SNaP(R) (Smart Negative Pressure(R)) System provides patients with a sophisticated, non-invasive NPWT system designed to promote wound healing, which weighs only 2.2 ounces and does not require batteries or electricity.

Several clinical studies have been published supporting the SNaP System as an effective alternative to electrically powered NPWT, including a comparative Randomized Controlled Trial (RCT) that also showed the small device makes a positive difference in patients’ quality of life. Recently, promising data from the multicenter RCT comparing the treatment of venous leg ulcers (VLU) using the mechanically powered SNaP System, to an electrically powered NPWT system, was presented at the Symposium on Advanced Wound Care (SAWC) Spring Conference in April.

According to Spiracur’s chief scientific officer, Kenton Fong, M.D., “This recent RCT data shows extremely promising results for the SNaP System when used to treat venous leg ulcers. Specifically, the data revealed that wounds treated with the SNaP System demonstrated greater improvement and a higher likelihood of complete wound closure than those treated with the electrically powered VAC system.”

About Spiracur Inc. Spiracur Inc., headquartered in Sunnyvale, Calif., is a privately held medical device company focused on the development of innovative wound healing technologies. Spiracur was founded out of the Stanford University Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System for the treatment of chronic and acute wounds, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The company’s ciSNaP(R) Closed Incision System with proprietary controlled tension relief is designed to improve healing of high-risk surgical incisions. Both devices have received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and have received CE Mark approval. Spiracur’s proprietary mechanically powered technology does not require batteries or electricity to operate. For more information, please visit http://spiracur.com .

Spiracur, Spiracur logo, SNaP, Smart Negative Pressure, and ciSNaP are registered trademarks of Spiracur Inc. VAC is a registered trademark of Kinetic Concepts, Inc.

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KCI settles Wake Forest wound care patent spat for $280M

KCI settles Wake Forest wound care patent spat for $280M

July 1, 2014 by Brad Perriello

Kinetic Concepts Inc. agrees to a $280-million settlement of its long-running patent infringement war with Wake Forest University over negative-pressure wound therapy technology.

KCI settles Wake Forest wound care patent spat for $280M

UPDATED July 1, 2014, with comment from KCI.

Kinetic Concepts Inc. said it agreed to pay $280 million to settle a patent infringement lawsuit with Wake Forest University, putting their long-running war over negative-pressure wound therapy to rest.

KCI licensed the NPWT patents from Wake Forest in 1993, but stopped paying royalties in 2011 after a federal judge in 2010 ruled the patents invalid.

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A year later KCI and wound-care rival Smith & Nephew (FTSE:SN, NYSE:SNN), which had been tussling over the technology since Smith & Nephew’s 2007 acquisition of Blue Sky Medical Group, put their legal battle to rest as well.

Yesterday KCI said that it agreed to settle with Wake Forest via a series of payments covering retrospective royalties on the patents.

The deal calls for KCI to pay $80 million this month, another $85 million in June 2015, $85 million in June 2016 and a final $30 million payment in June 2017, according to a regulatory filing.

The Settlement Agreement includes a stipulated dismissal with prejudice of the lawsuits between KCI and Wake Forest, including the lawsuit that was previously scheduled to begin trial on July 28, 2014 in the U.S. District Court for the Western District of Texas, San Antonio Division.

“We are pleased to have resolved all negative pressure wound therapy patent litigation with Wake Forest. KCI pioneered the use of negative pressure wound therapy products when we launched our first V.A.C. Therapy System in 1994 and in so doing, improved the lives of millions of people. Today, KCI’s V.A.C. Therapy has been the treatment of choice for more than 8 million wounds worldwide and is the most effective therapy for accelerating wound healing,” KCI general counsel John Bibb said in prepared remarks.