Health care systems lecture 9

Major trends shaping medical device development and use

Technology & Digital Health: Rise of AI/algorithm-driven tools, Software as a Medical Device (SaMD), connected devices linked to EHRs/apps, remote sensors, and enhanced cybersecurity requirements.

Home-Care Expansion: Shift toward hospital-level monitoring at home (e.g., continuous glucose monitors, wearable ECGs, smart inhalers) paired with telehealth and smart drug-delivery systems.

Demographic & Economic Factors: Growing focus on prevention-oriented, consumer-facing health tools and data analysis platforms

How FDA classifies devices according to risk and regulatory controls

Class 1,2,3

Class 1

Class I (Low Risk): Subject to general controls (e.g., labeling, registration) and usually exempt from premarket review

Class 2

Class II (Moderate Risk): Subject to general controls plus special controls; typically requires 510(k) clearance

Class 3

Class III (High Risk): Life-sustaining, life-supporting, or implantable devices; requires premarket approval (PMA) due to potential risk

Differences between regulatory pathways 501K

(Premarket Notification): For low/moderate-risk devices; grants FDA clearance based on "substantial equivalence" to an existing legal device (predicate).

Differences between regulatory pathways De Novo

De Novo: A classification pathway for novel, low- to moderate-risk devices that have no existing predicate

Differences between regulatory pathways PMA

PMA (Premarket Approval): For Class III high-risk devices; requires full scientific and clinical evidence to get FDA approval

Differences between regulatory pathways HDE

HDE (Humanitarian Device Exemption): An approval pathway for conditions affecting fewer than 8,000 U.S. individuals/year; exempt from standard effectiveness rules if safety and probable benefit are shown

Differences between regulatory pathways IDE

IDE (Investigational Device Exemption): Authorizes a device to be used in clinical trials for study; it is not a marketing authorization

How device oversight continues across the total product lifecycle

Regulation does not stop at market entry; it connects premarket review, manufacturing quality, and post-market safety.

Oversight includes Quality Management System Regulation (QMSR/Part 820), Medical Device Reporting for adverse events/malfunctions, cybersecurity, real-world evidence tracking, software updates, and recalls