For companies with regulated medical technology, traversing the Food and Drug Administration (FDA) regulatory requirements quickly becomes a critical component of product strategy. As the regulatory landscape for medical technology rapidly evolves and new paradigms are created for novel products, Manatt professionals creatively and efficiently help companies navigate the process of bringing products to market and maintaining compliance in the postmarket phase.
We have significant experience helping innovators determine whether their medtech, digital health and in vitro diagnostic products are regulated by the FDA as well as guiding them through the regulatory maze to bring their products to market. From rapidly changing FDA digital health policy to regulatory issues for laboratory developed tests (LDTs), we help companies understand the landscape and develop strategies to achieve business objectives. Similarly, we have significant experience helping life sciences and biotechnology companies manage complex advertising/promotion and compliance issues.
Manatt leverages our novel model of attorney and consultant interdisciplinary teams in these engagements, bringing together legal and strategic business problem-solving in order to not just obtain marketing authorization, but also succeed in the marketplace.
Who we work with
- Digital health companies
- Diagnostic companies
- Medtech companies
- Pharmaceutical and biotechnology companies
What we do
- Develop creative regulatory strategies for AI-based products, VR and AR medical solutions, innovative wearable sensors, and complex digital therapeutic products, as well as numerous other types of medical products such as implants and infusion pumps.
- Develop presubmission packages in advance of meetings with the FDA, and support and facilitate those meetings.
- Draft, review and submit investigational device exemptions (IDEs), 510(k) notices, De Novo submissions and premarket approval applications (PMAs).
- Maintain compliance with ongoing regulatory obligations after initial marketing authorization.
- Address potential compliance concerns from cybersecurity considerations to advertising and promotion.
We successfully assisted the following companies:
- CuraCloud in obtaining 510(k) clearance for CuraRad-ICH, an AI-based CT-imaging triage software for intracranial hemorrhage.
- Caption Health (formerly Bay Labs) in obtaining De Novo marketing authorization for the innovative Caption Guidance, which uses artificial intelligence to provide real-time guidance and diagnostic quality assessment during acquisition of echocardiography, empowering healthcare providers—even those without prior ultrasound experience—with the ability to capture diagnostic quality images. Also in seeking 510(k) clearance for its EchoMD AutoEF software, which applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.
- Eko in obtaining 510(k) clearance for a suite of machine learning and signal processing algorithms designed to provide clinical decision support to physicians during the evaluation of cardiac data, and in obtaining Breakthrough Device designation for a novel ECG-based algorithm.
- IDx LLC in obtaining De Novo reclassification from the FDA for the groundbreaking AI-based IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.
- Biobeat in obtaining 510(k) clearance for the company’s noninvasive multiparameter wearable sensor (pulse rate, blood oxygen saturation and changes in blood pressure).
- Exact Sciences in obtaining FDA approval for Cologuard, the first noninvasive sDNA screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers.