Master Medical Device Development & FDA Regulatory Affairs

Trace the FDA history, device failure case studies, and US regulatory structure; explore pre-market forms, medical device definitions, intended use and indications for use, and FDA guidances and consensus standards.

Trace the evolution of FDA medical device regulations from 1906 to the 1976 amendments, covering pre-market submissions, risk classification, IDEs, and design controls.

Explore the U.S. regulatory structure and the FDA’s role within it, including CFR, the U.S. Code Title 21, and the premarket pathways PMA and 510(k), plus postmarket considerations.

Explore the ISO 14971 definition. Learn how software, in vitro use reagents, and implants fall under medical devices, and how they differ from drugs.

Explain how to craft the intended use statement per ISO 14971 and FDA, covering general purpose, indications for use, patient population, user profile, environment, operating principles.

Examine the FDA medical device definition, including the three parts a–c, and note the 360 J exclusions—administrative support, healthy lifestyle apps, and electronic patient records.

Explore how the FDA classifies medical devices by risk (class I–III), identify product codes, and determine the pre-market pathway (510(k) or PMA) for your device, including substantial equivalence and exemptions.

Learn how the FDA classifies devices into class I, II, and III by risk, determines regulatory controls and pathways (510(k), PMA, de novo, HDE), and uses product codes.

Learn how FDA product codes classify medical devices into classes and shape the required premarket pathway, using FDA databases and real examples like stethoscopes and thermometers.

Learn how regulatory affairs inform product development by using FDA databases and product codes to guide design team with special controls, guidance documents, and consensus standards that shape risk management.

Register your establishment and devices with the FDA at commercial distribution, per 21 CFR part 807, with foreign firms required to register before export and with annual renewal of fees.

Explore how a probe cover can be a component or an accessory of a digital thermometer. Determine how this choice shapes FDA submissions, product codes, risk management, and applicable standards.

Understand how sterile devices prevent infection by using sterile barrier systems and aseptic presentation, and explore sterilization methods such as steam, dry heat, ethylene oxide, and irradiation.

Master configuration management for medical devices by defining items with product name, model number, catalog number, and version; manage variations, change control, and streamlined FDA submissions.

Identify how to classify an electrosurgical generator for FDA pathways by defining parent devices and accessories and selecting the OAB product code for 510(k) planning.

Identify a predicate and establish substantial equivalence through the 510(k) flowchart, using FDA databases and testing data to inform design, risk management, and pre-sub meeting planning.

Explore bench, nonclinical, animal, and clinical performance testing within the V-model and design controls, using test protocols and reports to support PMA or 510(k) submissions.

Explore usability testing and human factors engineering, guided by IEC 62366 and FDA guidance, to design safe user interfaces for medical devices in real use environments.

Plan, collect, and analyze clinical data for medical devices to verify safety and performance using clinical investigations, literature, adverse event data, and risk management for 510(k) and PMA.

Compare clinical investigation and clinical evaluation, and learn to plan, appraise, and document safety and effectiveness using clinical evaluation plans and reports within risk management.

Explore when clinical investigations occur in medical device development, from early production builds to regulatory submission, and outline preclinical, pilot, pivotal, and post-market studies with risk management and design controls.

Explore regulatory requirements around medical device labelling, including device, product, and package labels, information and instructions for use, symbols, UDI, and creating label artworks with Inkscape.

Define labeling and markings for medical devices, distinguishing device labels from packaging labels, and identify durably affixed markings and essential content like instructions for use, intended use, and symbols.

Explore labeling and accompanying information for medical devices, detailing intended use, indications, contraindications, instructions for use, safety symbols, and technical description per ISO 20417 and ISO 15223.

Learn to use ISO 15223 symbols on device and packaging labels, guided by risk management and usability engineering, with Inkscape templates to create legible, compliant medical device labels.

Explore information for safety as a risk control measure within risk management to reduce device risk with instructions for use, warnings, safety symbols, labeling, and post-production traceability.

Explore CFR part 801 labeling requirements, including manufacturer details, dates, UDI, ISO 15223 symbols, and adequate directions for use and intended use under quality system regulation.

Examine false or misleading statements under section 801.6, and apply prominence of labeling, symbol usage, date formats, and language considerations for FDA-compliant device labeling.

Explore how the unique device identifier (udi) uniquely identifies medical devices across labels and packaging, detailing the device identifier and production identifiers, and exemptions.

Learn how to obtain a UDI from issuing agencies, choose formats like GS1 128 or data matrix, complete license setup, print and encode UDIs on labels, and register with FDA's GUDID.