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FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review

by | Jan 28, 2019 | Essential, FDA-lir, Industry Buzz-lir, Laboratory Industry Report

From - Laboratory Industry Report Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including… . . . read more

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here’s a quick recap.

The 510(k) Pathway
Device and diagnostics manufacturers can use the 510(k) pathway to get expedited approval for new products that they can show are substantially equivalent to products that were grandfathered in when Congress created the pathway in 1976. Translation: Technology that’s 40 or more years-old is being used as the standard for letting new products into the market.

There’s a perception that we’ve gone too far in stretching what’s “equivalent,” and that new 510(k) approvals should be compared to the benefits and risks of modern technology, notes Philadelphia attorney Janice Hogan who represents companies in the 510(k) process.

The New Proposal
The FDA recognizes the problem and has taken steps to address it. In April 2018, the agency suggested that substantial equivalency of new products be evaluated based on objective performance criteria rather than predicate devices. The November guidance advances that objective via establishment of an alternative 510(k) pathway (to be called the “Safety and Performance Based Pathway”) that allows manufacturers of certain-well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence.

The proposal also calls for modernization by way of embarrassment via publication of manufacturers and products relying on predicate technology over 10-years-old.

Impact on the Lab Industry
Hogan suggests that the new rules will have less impact on diagnostics than therapeutics given the former’s current reliance on newer predicates. What’s more, adds Hogan, 510(k) may  become moot for diagnostics if some version of the Diagnostic Accuracy and Innovation Act (DAIA) (see NIR, September, 2018) is passed. Explanation: DAIA would establish a new pathway for diagnostic tests instead of continuing to include them in the definition of a medical device within the scope of the 510(k) process.

Although it has bi-partisan support, Hogan cautions that DAIA is far from being a done deal. And unless and until it passes, new diagnostics will still have to go through the 510(k) process reach the market.

New FDA Approvals
Here’s a look at the key FDA approvals announced at the end of November through December:


Manufacturer(s) Product(s)
GenMark Diagnostics 510(k) clearance for ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel
Becton Dickinson 510(k) clearance for BD Max enteric viral panel, molecular test for detecting and differentiating pathogens causing viral gastroenteritis
Hycor Biomedical 510(k) clearance for Noveos allergy testing system and related assay for dust mite allergen detection
Myriad Genetics Expanded use for BRACAnalysis CDx in identifying advanced ovarian cancer patients eligible for AstraZeneca’s Lynparza (olaparib) as first-line maintenance therapy after responding to platinum-based chemotherapy
BioMérieux 510(k) clearance for BPA and BPN bottles used in quality control testing of platelets at blood banks using firm’s BACT/ALERT Virtuo blood culture system
Meridian Bioscience Clearance to market Alethia CMV Assay Test System Vitros XT 7600 Integrated System cytomegalovirus assay for newborns
Ortho Clinical Diagnostics Expanded use of Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator on firm’s Vitros ECi/ECiQ Immunodiagnostic Systems
Invivoscribe Technologies Expanded use for LeukoStrat CDx FLT3 Mutation Assay for use with with Xospata (gilteritinib), Astellas Pharma drug for patients with relapsed acute myeloid leukemia and FLT3 mutation
Loxo Oncology Approval for Vitrakvi (larotrectinib), TRK inhibitor is for the treatment of solid tumors characterized by an NTRK gene fusion and no acquired resistance mutation
Mesa Biotech Approval and CLIA waiver for Accula RSV respiratory syncytial virus test
DiaSorin Molecular Clearance for Simplexa GBS Direct assay for use on firm’s Liaison MDX instrument for qualitative detection of group B Streptococcus nucleic acid

New CE Marks & Global Certifications

Notable European CE certifications:


Manufacturer(s) Product(s)
Novacyt CE marking for Genesig BK virus (BKV) and Epstein-Barr virus (EBV) diagnostic kits
Cepheid CE-IVD clearance for rapid molecular assay to measure viral load of hepatitis B in infected patients
Quidel CE marking for point-of-care Sofia 2 Lyme+ fluorescent immunoassay
Quidel CE marking for TriageTrue High Sensitivity Troponin I Test for determining troponin I levels as an aid in diagnosing myocardial infarction
Systaaq Diagnostic Products CE marking for real-time PCR-based hepatitis B diagnostic
HiberGene Diagnostics CE marking for HG Flu A/B Combo test
PredictImmune CE-IVD marking for PredictSure IBD test for inflammatory bowel disease
AusDiagnostics CE-IVD marking for molecular diagnostic assay to detect hemochromatosis
SpeeDx CE-IVD marking for Resistance GC, qPCR assay to detect Neisseria gonorrhoeae and sequences in gyrA gene of bacteria linked to ciprofloxacin susceptibility
Asuragen CE marking for AmplideX DM1 Dx kit for diagnosis of myotonic dystrophy type I (DM1)
PerkinElmer CE-IVD marking for Vanadis NIPT system

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Atomo Diagnostics Australia Therapeutic Goods Administration approval for Atomo Self Test, self HIV test
Genobio South Korea Korean Ministry of Food and Drug Safety approval for GenoCTC isolation kit
Oxford Immunotec Global China China Food and Drug Administration approval for T-Cell Select, immune cell separation reagent kit
OpGen Colombia Instituto Nacional de Vigilancia de Medicamentos y Alimentos approval to market QuickFISH rapid pathogen identification products

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