Device Authorizations: MYRIAD myChoice CDx diagnostic, PENTAX duodenoscope, MISIGHT contact lens, TULA system for otitis media

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MYRIAD myChoice® CDx

Myriad Genetic Laboratories, Inc.

INDICATION FOR USE: Next generation sequencing-based in vitro diagnostic test that assesses the qualitative detection and classification of single nucleotide variants, insertions and deletions, and large rearrangement variants in protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes and the determination of genomic Instability Score (GIS) which is an algorithmic measurement of Loss of Heterozygosity (LOH), Telomeric Allelic Imbalance (TAI), and Large-scale State Transitions (LST) using DNA isolated from formalin-fixed p raffin embedded (FFPE) tumor tissue specimens.

The results of the test are used as an aid in identifying ovarian cancer patients with positive homologous recombination deficiency (HRD) status for treatment with the targeted therapy  in accordance with the approved therapeutic product labeling.

ADDRESSING UNMET NEED: First diagnostic for testing of FFPE ovarian tumor tissue for the selection of patients who are eligible for treatment with niraparib (Zejula)

DEVICE DESCRIPTION:

  • Single-site assay; includes reagents, software, instruments and procedures for testing DNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor samples
  • Employs single DNA extraction method from FFPE specimens, 30-200 ng of which undergoes multiple steps including fragmentation, end repair and adenylation, adapter ligation, library construction/amplification, hybridization and capture, sequencing and data analysis

EFFECTIVENESS & SAFETY:

  • Clinical test as an aid to clinicians in identifying ovarian cancer patients who may be eligible for treatment with Zejula (niraparib)
  • Primary endpoint: Overall Response Rate (ORR), key secondary endpoints were ORR in all patients and Median DOR (duration of response) in all patients
  • In patients with tBRCAm tumors (n=63), ORR was 28.6% and median DOR 9.2 mo.
  • Statistically significant overall response rate with clinically meaningful DOR seen in  patients with deleterious or suspected deleterious BRCA mutation, positive GIS status,  patients who had received prior chemotherapy
  • Overall, the response rate is better than what would be expected of available therapy and represents an improvement in a surrogate endpoint that is reasonably likely to predict clinical benefit
  • Risks are associated with potential mismanagement of patients resulting from false results of the test or a failure to receive results

REGULATORY PATHWAY: PMA

  • Device Generic Name: Next Gen Sequencing oncology panel, somatic or germline variant detection system
  • Device Procode: PQP

Patient Labeling: Test Request Form


CapturePENTAX Medical Video Duodenoscope ED34-i10T2

Pentax

INDICATION FOR USE: To provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems

ADDRESSING UNMET NEED: First duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection. Represents a major step toward lowering the risk of infection among patients who undergo procedures with these devices

DEVICE DESCRIPTION:

  • Intended to be used with endoscopic devices, introduced in patient’s mouth
  • Provides visualization via a video monitor of and therapeutic access to the biliary tract (liver, gall bladder and bile ducts) through the upper gastrointestinal tract
  • Risks: Ootential for injuries, including, but not limited to, burns, electric shock, perforation, infection and bleeding

REGULATORY PATHWAY: 510(k)


CaptureMISIGHT (omafilcon A) contact lens

Cooper Vision

INDICATION FOR USE: Single use Soft Contact Lenses for the correction of myopic  ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75  to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism.

The lens is to be discarded after each removal

ADDRESSING UNMET NEED:  First contact lens indicated to slow the progression of myopia (nearsightedness) in children, which ultimately could mean a reduced risk of developing other eye problems

EFFECTIVENESS & SAFETY:

  • Three-year randomized, controlled clinical trial , n=135 children ages 8 to 12, MiSight vs. conventional soft contact lens
  • Progression in myopia with MiSight lenses less than conventional lenses, less change in the axial length of eyeball at each annual checkup
  • No serious ocular adverse events in either arm of the study
  • Additionally, real world data from a retrospective analysis of n-782 medical records from seven community clinics. Ulcer rate comparable to adults who wear contact lenses daily
  •  Required postmarket study to further evaluate the safety and effectiveness

REGULATORY PATHWAY: PMA

  • Classification name:  Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
  • Product Code: QIT

LABELING


Capture.JPGTULA System

Tusker Medical

INDICATION FOR USE: Tubes Under Local Anesthesia (TULA) System for delivery of tympanostomy tubes, that can be inserted into the eardrum to treat recurrent otitis media.

ADDRESSING UNMET NEED: An option for the treatment of recurrent ear infections that does not require general anesthesia. Has the potential to expand patient access to treatment that can be administered in  physician’s office with local anesthesia and minimal discomfort

DEVICE DESCRIPTION:

  • Consists of an Iontophoresis System, a local anesthetic, and a Tube Delivery System
  • Iontophoresis System is designed to provide child-friendly bilateral local anesthesia of the tympanic membrane, enabling a viable alternative to general anesthesia
  • Once the tympanic membrane is numb, the Tube Delivery System is used to insert the tympanostomy tube
  • With a single button push, the Tube Delivery System automatically creates the myringotomy and inserts the tube in less than 500 milliseconds
  • Parents are present during the TULA office-based procedure, and younger children may sit on their parent’s lap, if desired.

EFFECTIVENESS $ SAFETY:

  • Study with 222 pediatric patients to assess the effectiveness of the Tula System for the delivery of ear tubes
  • Procedural success rate was 86% and 89% in children younger than age 5 and between ages 5-12 years old, respectively
  • Most common adverse event: Inadequate anesthesia during the procedure.

REGULATORY PATHWAY: PMA

  • Breakthrough Device designation

Image Credit:Myriad Genetic Laboratories, Pentax, Cooper Vision, Tusker Medical

News & Views: Cybersecurity, Technology Modernization Action Plan, Implementing SUPPORT Act, Homeopathic products oversight, Breast implants safety, CBD warning for pregnancy, CDRH Patient Engagement, New youth e-cigarette education

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Medical Device Cybersecurity : Information for patients

New technologies can be implantable or wearable, used at home or in health care settings: Safer, timelier and more convenient

Anytime a medical device has software and relies on a wireless or wired connection, vigilance is required : Vulnerable to cyber threats and requires cybersecurity

Patients need to

  • Apply software updates
  • Register device with manufacturer
  • Be observant and vigilant
  • Involve  family or caregivers
  • If there is a serious event, seek medical attention.

Capture.JPGFDA’s Technology Modernization Action Plan (TMAP)

Technological foundation for development of FDA’s ongoing strategy around data

  • For stewardship, security, quality control, analysis, and real-time use of data
  • Will accelerate path to better therapeutic and diagnostic options

Proposal to

  • Modernize FDA’s technical infrastructure 
  • Develop technology products to support FDA’s regulatory mission
  • Communicate and collaborate with stakeholders to drive technological progress that is interoperable across the system

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Capture.JPGFDA first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

FDA’s implementation of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act)

  • Clarifying FDA regulation of non-addictive pain products
  • Evidence-based opioid analgesic prescribing guidelines and report
  • Strengthening FDA and U.S. Customs and Border Protection (CBP) coordination and capacity
  • Restricting entrance of illicit drugs
  • Safety-enhancing packaging and disposal
  • Clarifying FDA postmarket authorities
  • Study on abuse-deterrent opioid formulations access barriers under Medicare

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Capture.JPGEfforts to protect patients from potentially harmful drugs sold as homeopathic products

Homeopathic products are marketed without FDA review and may not meet standards for safety, effectiveness, quality and labeling

  • Issuance of draft guidance discussing risk-based enforcement approach to drug products labeled as homeopathic
  •  Withdrawing outdated Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed”

Risk-based approach with appropriate regulatory and enforcement actions when  patients are being put at risk

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Capture.JPGEfforts to protect women’s health and enhance safety information available to patients considering breast implants

 Draft guidance  to ensure patients have complete information about the benefits and risks of breast implants

  • Boxed Warning in labeling: Not lifetime devices, chances of developing complications, associated with risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  • Inclusion of patient decision checklist at end of patient informational booklet
  • Revision of rupture screening recommendations for silicone gel-filled implants
  • Inclusion of product  ingredient information  that is easily understood by patients

To help patients better understand breast implant benefits and risks in making health care decisions that fit patients’ needs and lifestyle 

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CaptureWarning against Using Cannabis, Including CBD, When Pregnant or Breastfeeding

FDA strongly advises against use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding

Unapproved products and FDA does not know

  • safety and effectiveness to treat a particular disease
  • what, if any, dosage may be considered safe
  • interaction with other drugs or foods
  • whether they have dangerous side effects or other safety concerns

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CaptureCDRH Patient Engagement

Mission to engage with patients, understand their perspective, and proactively integrate the patients’ perspectives into the total product life cycle of medical devices 

  • Designing medical devices
  • Planning and conducting medical device clinical investigations
  • Informing CDRH’s thinking on current issues impacting a patient community
  • Helping to identify emerging signals
  • Communicating safety messages
  • Identifying specific populations’ perspectives on benefit-risk for a given treatment

Ways to engage

Contact: CDRH_PatientEngagement@fda.hhs.gov.

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CaptureWork  with Scholastic with launch of new youth e-cigarette prevention educational resources for middle and high schools

Education is an important complement to the FDA’s overarching youth tobacco prevention efforts

  • Continuing to educate youth, parents, and teachers about the dangers of e-cigarette use
  • Joined forces with Scholastic to develop and distribute educational resources to high school educators across the country
  • Expanding collaboration with Scholastic to include middle school educators
  • Help ensure that > one million middle and high school teachers have resources to start educational conversations about the harms of e-cigarette use with their students

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Image credit: FDA