Regulatory Focus™ > News Articles > FDA to Device Industry: Teach us More About Diagnostics and Sequencing

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Posted 08 April 2015 | By Alexander Gaffney, RAC

FDA to Device Industry: Teach us More About Diagnostics and Sequencing


The US Food and Drug Administration's (FDA) medical device regulators are once again preparing to expand a program they use to learn about cutting-edge and essential medical technologies, this time with a particular focus on in vitro diagnostics and next generation sequencing (NGS) technology.


The program FDA has proposed to extend is known as the Experiential Learning Program (ELP), and was first proposed in September 2011 by FDA's medical device regulatory body, the Center for Devices and Radiological Health (CDRH).

The ELP is meant to allow FDA's regulators to learn more about the technologies they currently regulate and will likely regulate in the near future. The program, which was officially launched in April 2013, works by allowing FDA officials to attend "formal training visits" at industry sites. Companies choose to cooperate with FDA on a voluntary basis, FDA confirmed, and the visits are not intended to "inspect, assess, judge, or perform a regulatory function," FDA said.

In a September 2011 statement announcing the launch of the program, CDRH Director Jeffery Shuren said the ELP would "help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care."

“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews,” said Shuren. “This investment will improve the quality of submission review and make the process more consistent and predictable.”

To date, FDA has identified several dozen areas of interest, ranging from the manufacture of companion diagnostics to the operation of clinical testing in CLIA high-complexity laboratories.

An Expanding Focus

Since ELP's launch in 2013, FDA has refined the number and types of topics it says it is interested in learning about.

For example, in August 2014, FDA said it would launch a "new component" of the ELP in the hopes of providing CDRH staff with "the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle." The new component is known as the "ELP General Training Program," and is focused primarily on the premarket review process.

But the ELP has been refined in other ways as well. When the ELP launched in April 2013, it had">27 areas of interest, according to a Federal Register notice announcing the start of the program. One year later, FDA had refined that list down to 22 areas.

Now FDA is proposing a new, greatly expanded list of areas of interest for its ELP.

In a 8 April 2015 Federal Register notice, FDA said it had identified 34 areas of interest for its latest iteration of the ELP. Much of FDA's new interest is related to in vitro diagnostics, a review by Regulatory Focus has found.

For example, in 2014 FDA said it was interested in learning more about eight topics related to in vitro diagnostics. In 2015, it selected a whopping 20 new topics of interest related to in vitro diagnostics and manufacturing technology.

Areas of Interest—In Vitro Diagnostic and Radiological Devices/Technology
Focus areaSpecific areas of interest
Manufacturing of glucose test strips and metersObservation of the manufacturing and in-process and finished device testing of glucose monitoring devices.
Manufacturing of continuous glucose monitoring systems and insulin pumpsObservation of the manufacturing and in-process and finished device testing of glucose monitors and insulin pumps.
Manufacturing of chemistry devicesObservation of the manufacturing and in-process and finished device testing of point of care chemistry cassettes/cartridges/strips for smaller chemistry analyzers used in clinical and point of care settings.
Manufacturing of chemistry reagent, controls and calibratorsObservation of the manufacturing and in-process and finished device testing of chemistry reagents, calibrators, and controls for common chemistry analytes used in a clinical laboratory setting.
Manufacturing of urine test strips and readersManufacturing and observation of in process or finished device testing for urine test strips and meters in clinical laboratory and point of care testing settings.
Manufacturing and development of IHC (immunohistochemistry) devicesObservation of manufacturing, in-process testing, and/or finished device testing of IHC devices (used in the diagnostic evaluation of cancer, classification of tumors, or companion diagnostic testing).
Manufacturing and development of ISH (in situ hybridization) devicesObservation of the manufacturing, in-process testing, or finished device testing of colorimetric in situ hybridization (CISH) and/or fluorescent in situ hybridization (FISH) assays used in identifying specific nucleic acid sequences within tissue sections (for diagnostic and/or treatment decisions).
Manufacturing and development of NGS (next gen sequencing) platforms and devicesObservation of NGS sequencing platforms, bioinformatic analysis of the resulting sequence information, and types of interpretative software for potential clinical purposes.
Manufacturing, development and observation of CTC (circulating tumor cells) devicesObservation of the manufacturing, in-process testing, or finished device testing of CTC devices that assess the prognosis of patients with metastatic breast, colorectal, or prostate cancer (manufacturing site or research site or clinical setting).
Manufacturing, development and/or observation of clinical mass spectrometers and high performance liquid chromatography (HPLC) devicesObserve the manufacturing, development and/or demonstration of clinical mass spectrometers and HPLC as part of laboratory workflow including sample preparation, equipment usage, and data analysis.
Manufacturing, development and research of flow cytometry devices and componentsManufacturing, research, and development of in-process testing, or finished device testing of cytometry analyzers and accompanying components.
Manufacturing of immunoassays for autoimmune diseasesManufacturing and development of in-process testing, or finished device testing, for diagnostic evaluation and research.
Manufacturing and development of coagulation—point of care devicesManufacturing and development of in-process or finished device testing for point of care devices such as Prothrombin Time and International Normalized Ratio (PT/INR) meters.
Manufacturing and product development of global hemostasis testing devicesManufacturing of global hemostasis testing for anti-coagulants and anti-platelet drugs for new molecular targets to assess the level of drug-induced inhibition for qualitative and quantitative evaluation.
Manufacturing and product development of direct anticoagulants assays/controls/calibratorsManufacturing and development of assays, controls, and calibrators for the detection of direct anticoagulants.
Observation of testing of sequencing technologies in large sequencing centersVisit a sequencing center where various sequencing methods are used for different applications other than in vitro diagnostic devices (IVD) manufacturing.
Manufacturing, and product evaluation of IVDs using next generation sequencing (NGS) technologyVisit a manufacturer of IVD designed for sequencing of microorganisms for identification purposes.
Clinical applications-NGS in practiceVisit a clinical laboratory that uses NGS as a diagnostic/screening tool.
Antimicrobial susceptibility testing (AST)Visit to a manufacturer of antimicrobial susceptibility test platforms intended for use in clinical laboratory settings.
Antimicrobial susceptibility testing (AST)Visit to a clinical laboratory that employs various AST methodologies for identification of antibiotic resistance.

Other Topics of Interest

In contrast, FDA said it is interested in studying 14 areas of interest related to medical devices and technology in 2015—the same number it selected in 2014.

Areas of Interest—Medical Devices/Technology 
Focus areaSpecific areas of interest 
Failure analysis of orthopedic devicesMethods for retrieval and preservation of failed implants for analysis; understanding how retrieved implants may be analyzed; methods for identifying failure modes; understanding how analysis of failed implants influences device design modifications. 
Radiologic analysis of orthopedic devicesMethods of radiologic analysis and associated data analyses; radiologic imaging core laboratories. 
Automated external defibrillators (AEDs)Manufacturing process; incoming component inspection; design verification testing; human factors testing; returned product testing (as available). 
Diagnostic imaging catheters for cardiovascular diseasesManufacturing process; design verification testing; returned product testing (as available); ultrasound, optical coherence tomography (OCT), and near infrared spectroscopy (NIS) catheters. 
Endovascular grafts for treatment of aortic aneurysmsPhysician-sponsored clinical studies; observation of endovascular grafting surgical procedure; surgical planning process; factors that influence device modifications (e.g., patient anatomy, patient pathology). 
Animal models for evaluation of hemostatic devicesModels of traumatic injury and severe hemorrhage; limitations of the model; understanding the relevance of the data generated from these models in evaluating hemostatic devices. 
Hyaluronic acid in dermal tissue fillersManufacturing process; source materials; performance testing (e.g., material characterization, biocompatibility, residence time). 
Minimally invasive glaucoma surgery (MIGS) devicesObservation of a MIGS procedure; surgical planning; surgical challenges. 
Neurointerventional devicesStents, flow-diverters, mesh balls, coils, and other related devices; observation of surgical procedures; understanding of clinical decision making for relevant patient populations; manufacturing; performance testing. 
Implantable functional electrical stimulation devicesObservation of implantation procedure; surgical challenges. 
Male condomsManufacturing process; lot release testing (e.g., airburst, water leak, dimensional analysis). 
Solid organ preservation devicesObservation of organ preservation procedures; pulsatile perfusion (for either cold storage or normothermia). 
Infusion pumpsManufacturing process; device design considerations; patch pumps; insulin pumps; implantable infusion pumps; implantable ports. 
Bone grafting materials for dental applicationsManufacturing process; sourcing process; viral inactivation testing; animal testing. 

Companies interested in participating in CDRH's ELP should submit participation proposals to FDA through its Federal Register docket.


Federal Register notice


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