INDUSTRY BUZZ

FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results

On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to market. Under the “Safety and Performance Based Pathway” (new Pathway), new product approval will be based on consensus standards rather than direct predicate comparisons with previously approved devices.

How the New Pathway Works
The new Pathway is to be used when FDA determines that:

  • The new device has indications for use and current technological characteristics that don’t raise safety and effectiveness questions different from identified predicates;
  • The predicate is within the scope of the list of eligible device types;
  • The performance criteria align with the performance of one or more modern legally marketed devices of the same type as the new device; and
  • The new device meets all FDA-identified performance criteria.

If the above criteria are met, the FDA may request and review underlying data and testing methodologies as necessary to find that a new device is substantially equivalent. If any of the criteria aren’t met, the manufacturer can seek approval through the Traditional, Special or Abbreviated 510(k) pathways.

When the New Pathway Will Become Available
In its press release, the FDA outlined its implementation plans:

  • Create a list of device types eligible for the new Pathway with input from industry;
  • Establish criteria applicable to each device type;
  • Issue new guidance listing the eligible device types and corresponding criteria;
  • Hold a webinar and take other steps to educate stakeholders how to use the new Pathway.

Once the new Pathway launches, the FDA will publish the list of device types and applicable criteria on its website and review them on a periodic basis.

Discouraging Use of Older Predicates
In a separate action, the FDA issued a notice requesting comments on approaches to drive sponsors to offer patients devices with the latest improvements and advances. Specifically:

  • Should the FDA publish a list of devices or manufacturers that rely on predicates that have been on the market for more than a certain number of years?  If so, what number of years should that be?
  • Should the FDA consider using other criteria to inform its point of reference?
  • What other actions should the agency FDA take to promote use of more modern predicates?
  • Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?

Deadline to comment: April 22.

New FDA Approvals
The other headliner from January was the agency’s first ever approval for a direct-to-consumer test company (23andMe) to provide pharmacogenetic test results to customers without a doctor’s order. 23andMe CEO and co-founder praised the decision for opening “the door for consumers to work with their health providers to better manage their medications,” However, some experts caution that patients may be tempted to bypass their doctors and medical lab testing if they’re directly informed how they metabolize medications on the basis of genetic testing.

Here’s a look at the other key FDA approvals announced at the end of December through the final days of January:

NEW FDA APPROVALS
Manufacturer(s) Product(s)
Illumina Breakthrough device designation for TruSight Oncology Comprehensive pan-cancer assay
Hologic de novo clearance to market Aptima assay for Mycoplasma genitalium sexually-transmitted infection
Phadia AB (ThermoFisher Scientific) Clearance for EliA RF IgM immunoassay for measuring IgM class rheumatoid factor antibodies in serum and plasma to diagnose rheumatoid arthritis operating on Phadia 2500/5000 instrument
Thermo Fisher Clearance for Thermo Scientific QMS Plazomicin Immunoassay
PTS Diagnostics Clearance for PreVantage medical device convenience kit for quantitative measuring percentage of glycated hemoglobin, total cholesterol, high-density lipoprotein, triglycerides and glucose in whole blood
ArcherDx Breakthrough device designation for companion diagnostic assay
Grifols Clearance for Erytra Eflexis, a fully automated benchtop analyzer for pretransfusion compatibility testing
DiaSorin Molecular Clearance for Simplexa Bordetella Direct assay to detect pathogens that cause pertussis or whooping cough
Miris Marketing authorization after de novo premarket review of Miris Human Milk Analyzer for measuring nutrients in breast milk
GenMark Diagnostics 510(k) clearance for ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel molecular diagnostic panel assay to detect fungal pathogens from blood cultures of patients with suspected blood stream infections run on the firm’s ePlex system
BioMérieux Approval for Vitek MS mass spectrometry system to identify microorganisms cultured from human specimens
Lin-Zhi International Clearance for LZI Fentanyl Enzyme Immunoassay for detection of norfentanyl in human urine at cutoff of 5 ng/mL
Ark Diagnostics Clearance for immunoassay for detection of tramadol in urine at cutoff of 100 ng/mL
Sekisui Diagnostics Clearance for Acucy Influenza A & B test for use with Acucy system and Influenza A & B control kit
Axis-Shield Diagnostics Clearance for Advia Centaur Calcitonin assay to diagnose and treat thyroid and parathyroid gland diseases, including carcinoma and hyperparathyroidism
YD Diagnostics Clearance to market UriScan 10ACR urine strips run on UriScan Optima urine analyzer to measure blood, acetoacetic acid, protein, nitrite, glucose, pH, specific gravity, leucocytes, albumin and creatinine

New CE Marks & Global Certifications
Notable European CE certifications:

NEW CE CERTIFICATIONS IN EUROPE
Manufacturer(s) Product(s)
NuGenerex Diagnostics CE marking for Express II Syphilis TreponemalAssay rapid, point-of-care syphilis test
Theradiag CE marking for Lisa Tracker drug response kit for Novartis’ Cosentyx (secukinumab) treatment for psoriasis, psoriatic arthritis and ankylosing spondylitis
Chembio Diagnostics CE marking for diagnostic test developed with AstraZeneca to detect an undisclosed biomarker using firm’s DPP platform
Mobidiag CE-IVD marking for its Novodiag CarbaR+ test for carbapenemase-producing enterobacteriaceae (CPE), a bacterium resistant to carbapenem antibiotics

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Qiagen Canada    Health Canada approval for QuantiFeron-TB Gold Plus (QFT-Plus) test for latent tuberculosis infection
Qiagen Japan Japanese Pharmaceuticals and Medical Device Agency approval for Therascreen EGFR RGQ PCR kit as companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for EGFR mutation-positive, inoperable or recurrent non-small cell lung cancer
Foundation Medicine Japan Ministry of Health, Labour and Welfare approval for FoundationOne CDx genomic profiling assay
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