FDA Market Authorizations: VISUMAX Laser, BIOMIMICS 3D Stent, PERSONAL GENOME SERVICE Pharmacogenetic Reports, FLUOBEAM 800 Clinic Imaging Device, Biosimilars: UDENCYA, HYRIMOZ

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VisuMax Femtosecond Laser

 Carl Zeiss Meditec, Inc.

INDICATION FOR USE: In small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism:

  • For spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters
  • For cylinder from -0.75 diopters through -3.00 diopters
  • When refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude

DESCRIPTION

  • Precision ophthalmic surgical laser designed for creation of incisions in cornea
  • Mimics cutting action of mechanical or blade-based keratomes
  • Accomplishes this by scanning tightly focused patterns of femtosecond laser pulses in cornea at precise and predefined positions and depths
  • Each laser pulse produces micro-photodisruption in tissue of only a few microns in size
  • Patterns of contiguous, focused laser pulses results in the creation of continuous cut surfaces in cornea

EFFECTIVENESS & SAFETY:

  • 12-month, prospective, multi-center, open-label, non-randomized clinical trial, 360 eyes of 360 consecutive subjects for reduction or elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or without astigmatism) and MRSE ≤ -11.50 D
  • The key effectiveness variables : Predictability: the percentage of eyes achieving MRSE within ± 1.00 D of the intended outcome,  Improvement in UCVA following treatment: the percentage of eyes that achieve uncorrected visual acuity (UCVA) of 20/40 or better
  • Predictability of MRSE: 99.1%
  • Improvement in UCVA: 98.6%
  • Most serious types of adverse events : 3 cases of intraoperative cap tears, several of the cases of epithelium in the interface, all objective types of adverse events occurred at rates less than 1%, no objective findings resulted in long-term serious sequelae

REGULATORY PATHWAY: PMA

  • Device Procode: OTL

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BioMimics 3D Vascular Stent System

Veryan Medical Limited

INDICATION FOR USE: To improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery, with reference vessel diameters ranging from 4.0 – 6.0 mm and lesion lengths up to 140 mm

DESCRIPTION:

  • Comprised of two components; (i) a Nitinol stent with a 3D helical profile in a range of lengths and diameters and (ii) an over-the-wire stent delivery system
  • 3D stent is a peripheral self-expanding nickel-titanium alloy (Nitinol)stent with 3D helical centerline geometry
  • Stent is laser cut from a straight Nitinol tube and 3D helical geometry is stored in the Nitinol shape memory
  • Three tantalum radiopaque markers are located at both ends of the stent to increase visibility of the stent to aid in placemen
  • 3D stent is mounted on a 6F over-the-wire stent delivery system (SDS) for use with a 0.035” guidewire

EFFECTIVENESS & SAFETY:

  • Prospective, single-arm, multicenter clinical trial,  in patients with intermittent claudication due to atherosclerotic disease of the femoropopliteal artery
  • Primary effectiveness endpoint: Primary stent patency rate at 12 months: 73%
  • Freedom from Major Adverse Event (MAE) comprising death, any major amputation performed on the target limb through 30 days: 99.6%

REGULATORY PATHWAY: PMA

  • Device Procode: NIP
  • Device Generic Name: Stent, Superficial Femoral Artery

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 Personal Genome Service (PGS) Pharmacogenetic Reports

23andMe

INDICATION FOR USE: Qualitative genotyping assessment system applied to genomic DNA isolated from human saliva collected using the Oragene Dx OGD500.001 to simultaneously detect, report, and interpret genetic variants in a broad multigene test. The assessment system is intended to enable users to access information about their genetics that could aid discussions with a healthcare professional.

The 23andMe Personal Genome Service Pharmacogenetic Reports are indicated for reporting of the following variants:

Gene Variant(s)
CYP2C19 *2, *3, *17
CYP2C9 *2, *3, *5, *6, rs7089580
CYP3A5 *3
UGT1A1 *6, *28
DPYD *2A, rs67376798
TPMT *2, *3C
SLCO1B1 *5
CYP2D6 *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *20, *29, *35, *40, *41

ADDRESSING UNMET NEED: 

  • Making information about genetic variants available directly to consumers
  • Better inform their discussions with their health care providers

GENERIC DEVICE TYPE: Pharmacogenetic assessment system

Qualitative in vitro molecular diagnostic system intended to detect nucleic acid variants isolated from human specimens for the purpose of identifying pharmacogenetic associations for the detected variants. The intended use of the device must not include an indication for use in supporting or sustaining human life, being of substantial importance in preventing impairment of human health, or presenting a potential, unreasonable risk of illness or injury.

EFFECTIVENESS & SAFETY: 

  • Data to show that the test is accurate (i.e., can correctly identify the genetic variants in saliva samples)
  • Provide reproducible results
  • Data on user comprehension studies that demonstrated that the test instructions and reports were understood by consumers
  • Test report provides information describing what the results might mean, what the test does not do and how to interpret results.

RISKS & MITIGATIONS:

  • Incorrect test results (false positive or false negative results): Special controls
  • Incorrect interpretation of test results: Special controls
  • Incorrect action based on test results: Special controls

REGULATORY PATHWAY: De Novo classification request

  • Regulation Number: 21 CFR 862.3364
  • Regulation Name: Pharmacogenetic assessment system
  • Regulatory Class: Class II
  • Product Code: QDJ

CLASSIFICATION ORDER


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Fluobeam 800 Clinic Imaging Device

Fluoptics

INDICATION FOR USE:  To provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.

The Fluoptics Fluobeam® Imaging system can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue.

Use of the Fluobeam® device is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

ADDRESSING UNMET NEED:  Provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands).

GENERIC TYPE OF DEVICE: Autofluorescence detection device for general surgery and dermatological use.

  • Adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.

EFFECTIVENESS & SAFETY:

  • Data from five peer-reviewed published studies, including one study that compared the rate of postoperative hypocalcemia (PH), or a temporary reduction in calcium in the blood, that occurs when healthy parathyroid tissue is inadvertently removed, n=93
  • 5 % experienced fluctuating PH following surgery (n=93) vs  21 % (n=153) patients who had surgery without the device

RISKS & MITIGATIONS:

  • Electrical, mechanical, or thermal hazards leading to user injury or discomfort:  Electromagnetic compatibility testing Electrical, mechanical and thermal safety testing, Software verification, validation, and hazard analysis, Labeling
  • Tissue, skin burn, or eye injury due to light and laser exposure: Light and laser exposure safety testing, Labeling
  • Infection and cross-contamination: Sterilization validation, Shelf life testing, Labeling
  • Adverse tissue reaction: Biocompatibility evaluation
  • False identification of target tissues or structures leading to errors in patient
    management (e.g., removal of healthy tissue or not removing diseased tissue): In vivo performance testing, Software verification, validation, hazard analysis, Labeling

REGULATORY PATHWAY: De Novo classification request

  • Previously cleared, via 510(k) pathway, as an imaging system used to capture and view fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion
  • De Novo pathway for new indication
  • Regulation Number: 21 CFR 878.4550
  • Regulation Name: Autofluorescence detection device for general surgery and dermatological use
  • Regulatory Class: Class II
  • Product Code: QDG

CLASSIFICATION ORDER


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Biosimilars: UDENCYA (pegfilgrastim-cbqv), HYRIMOZ (adalimumab-adaz)

Biosimilar product: Biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product.

UDENCYA (pegfilgrastim-cbqv) injection, biosimilar to NEULASTA (pegfilgrastim)

INDICATION: To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

HYRIMOZ (adalimumab-adaz) injection, biosimilar to HUMIRA (adalimumab)

INDICATIONS: 
  • Rheumatoid Arthritis: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HYRIMOZ can be used alone or in combination with methotrexate or other non- biologic disease-modifying anti-rheumatic drugs (DMARDs).
  • Juvenile Idiopathic Arthritis: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate.
  • Psoriatic Arthritis: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HYRIMOZ can be used alone or in combination with non-biologic DMARDs.
  • Ankylosing Spondylitis: Reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • Adult Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. HYRIMOZ is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
  • Ulcerative Colitis: Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP).
  • Plaque Psoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

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Image credits: Carl Zeiss Meditec, Veryan Medical Limited, 23andMe, Fluoptics, FDA

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FDA News and Views: Cybersecurity, Digital Health Advisor, Stakeholder update, Dsuvia Opioid Approval, E-cigarette cessation drugs, ASCA pilot, FDA-DoD collaboration

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The Medical Device Ecosystem and Cybersecurity — Building Capabilities and Advancing Contributions

Medical device cybersecurity is shared responsibility across the medical device ecosystem

  • In context of total product lifecycle
  • As part of interconnected cyber — physical infrastructure among people, processes, data and information and communication technologies
  • Identify and prepare for cyber intrusions, reduce medical device vulnerabilities, mitigate patient impact, enable timely restoration of devices and systems

Applying a best-teams approach  (with Dept. of Homeland Security, FDA Medical Device Safety Action Plan, Guidances on Premarket cybersecurity)

Building strategic alliances (with MITRE, MDIC)

Fortifying long-term commitment (Center of Excellence for Digital Health)

READ


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FDA Seeking Digital Health Advisor

Primarily serve as expert on  digital health technologies during FDA’s review and evaluation of digital health technologies

  • Review of first-of-a-kind digital health technology, precedent-setting research
  • Create preconditions and incentives informing digital health policy proposals
  • Provide advice, consultations and training
  • Assist with technology solutions to enhance CDRH internal processes

https://twitter.com/_bakulpatel


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Stakeholder Update: FDA’s 2018 Strategic Policy Roadmap

Update on priority areas to advance public health

Reduce the burden of addiction crises 

  • Address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation Read
  • Industry meetings on epidemic rates in youth e-cigarette use Read

Leverage innovation and competition to improve health care and access

  • Medical Device Ecosystem and Cybersecurity  Read
  • Authorization of first direct-to-consumer test for detecting genetic variants for medication metabolism

Read  


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Approval of Dsuvia and the FDA’s future consideration of new opioids

Dsuvia approval considerations in the context of the overall therapeutic armamentarium

  • Sublingual with restricted use in certified medically-supervised health care settings
  • Ideally suited for special circumstances where patients not able to swallow oral medication and access to intravenous pain relief is not possible
  • Potential uses on the battlefield – Department of Defense (DoD) worked closely with  sponsor on the development of opioid
  • Very tight restrictions on distribution and use with REMS
  • Quickly make regulatory adjustments if problems arise

READ


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Growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Public hearing on Dec. 5, to  focus on potential role of drug therapies to support cessation

  • Obtain input from across the medical and research fields, the pharmaceutical and tobacco industries, and public health stakeholders
  • Approaches to eliminate youth e-cigarette use
  • Exploring potential drug therapies to support youth e-cigarette cessation

READ


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Accreditation Scheme for Conformity Assessment (ASCA)

Piloted under CDRH’s Standards and Conformity Assessment Program

  • Enhance predictability of the medical device review process
  • Reducing premarket questions on conformity activities
  • Conformance declarations
  • Increase consistency of submissions and saving FDA resources

Pilot will ensure appropriate interaction between FDA, accreditation bodies, and testing labs

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FDA and DoD formalize collaboration to advance medical products in support of American military personnel

New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military

  • Evaluate how best to foster access to safe and effective medical products
  • Expedite review of priority DoD medical products
  • Provide technical  to aid rapidly  develop and manufacture medical products
  • Determine opportunities to streamline review and expedite availability
  • Authorize emergency uses of medical products to reduce deaths and severity of injuries caused by chemical, biological, radiological or nuclear (CBRN) agents

READ


Image credit: FDA