Topic
Regulation and policy
How medical-device, software, and drug regulation actually works, explained neutrally and without legal advice.
This page collects every article by Dr. Damon Tojjar in this topic. For all topics see browse by topic, and for the source-anchored record see damontojjar.com/record.
Articles in this topic (35)
- Why regulation is part of trustworthy medical AI
It is tempting to treat regulation as a hurdle that slows good ideas down. In medical AI it is closer to the opposite. The discipline of EU MDR, IVDR, FDA pathways,...
- The Accelerated-Approval Bargain: Surrogate Endpoints, Confirmatory Trials, and Faster Withdrawal
Accelerated approval is a conditional deal. It lets the U.S. Food and Drug Administration approve a drug for a serious condition based on a surrogate endpoint that...
- Biomarker Qualification Explained: Why a Measurement Has to Earn a Defined Use
A biomarker is qualified when a regulator formally accepts that it means a specific thing, for a specific purpose, well enough to be relied on in a defined setting....
- CE Marking Versus FDA Clearance: Two Routes a Medical Device Takes to Market
A CE mark and an FDA clearance both tell you a medical device passed a regulatory bar before reaching the market, but they are not the same bar, and neither one is...
- Cleared Is Not Approved: The 510(k) Pathway and Substantial Equivalence
A 510(k) clearance means the FDA agreed a device is substantially equivalent to one already on the market, not that a study showed it helps patients. It compares...
- Clinical Evaluation Versus Clinical Investigation, and Why Medical Software Needs Both
A clinical evaluation gathers all the evidence that bears on a device and judges whether it adds up to the claim. A clinical investigation runs a study to produce...
- The EU AI Act Digital Omnibus: Why the High-Risk Deadlines Moved
The EU AI Act's high-risk obligations no longer take effect in August 2026. Under the Digital Omnibus, on which the Council and Parliament reached political...
- How the EU AI Act Sorts Medical AI Into Risk Tiers, and What High Risk Means
The short answerThe EU AI Act does not treat all artificial intelligence the same way. It sorts systems into four bands by the risk they pose to health, safety, and...
- EU MDR and Software as a Medical Device, in Plain Language
If a piece of software is meant to diagnose a condition, recommend a treatment, or calculate a drug dose, the law in Europe treats it as a medical device, not as an...
- Expanded Access Versus Right to Try: Two Doors to an Unapproved Drug
A patient who has run out of approved options and cannot join a clinical trial may still reach an investigational drug through one of two federal routes. FDA...
- Reading a Drug Safety Signal: What FAERS and Disproportionality Can and Cannot Tell You
FAERS is the FDA's database of adverse-event reports, required from manufacturers and submitted voluntarily by health professionals and patients, and a...
- What Changed in FDA's 2026 Clinical Decision Support Guidance
On January 6, 2026, the U.S. Food and Drug Administration issued revised final versions of two long-standing digital health guidance documents: one on Clinical...
- How Health-Data Privacy Rules Work: A Plain Guide to GDPR and HIPAA
Two of the world's most influential health-data privacy frameworks solve the same problem from opposite directions. The EU's General Data Protection Regulation...
- How Much Evidence Proves a Drug Works? Two Trials, One Trial, or One Plus Confirmatory Evidence
United States law does not ask whether a drug might work. It asks for "substantial evidence" of effectiveness, a phrase written into the Federal Food, Drug, and...
- How Post-Market Surveillance Works: Watching a Device After It Reaches Patients
Post-market surveillance is the organized system that keeps watching a medical device after it clears regulatory review and starts reaching patients. It exists...
- How Regulators Grade Clinical Evidence, and Why the Bar Moves With Risk
When a regulator or assessor reads a clinical dossier, they grade it on three axes at once: how well each study was done, how closely it matches the people and the...
- How the WHO Classifies Digital Health, and Why a Shared Vocabulary Matters
The World Health Organization sorts digital health tools by a plain question: whom does this technology serve. Its Classification of Digital Health Interventions...
- Toward One Rulebook: International Harmonization for ML Medical Devices
In January 2025, the International Medical Device Regulators Forum (IMDRF) finalized a document, coded IMDRF/AIML WG/N88 FINAL:2025, that sets out ten shared...
- Predicate Devices and Substantial Equivalence, Explained for Medical Software
A predicate device is a device already legally on the market that a new device points to and says, in effect, this new thing is close enough to that cleared thing...
- Real-World Evidence in Regulation: What Data Outside a Trial Can and Cannot Decide
Regulators already use real-world evidence, and they have for years, but they use it for a narrower set of questions than the enthusiasm around it suggests. Data...
- Treating Regulation as a Design Input, Not a Box to Check
The teams that build the best medical software treat regulation as a design input from the first sketch, and the product comes out clearer and safer for it. When a...
- How to Build Health Technology That Treats Regulation as a Design Input
The best way to build health technology that people trust is to write the clinical claim before you write the code, then design the whole product as the evidence...
- How Medical Software Manages Risk: ISO 14971 and IEC 62304 in Plain Terms
The short answerMedical software is made safe less by any single clever test and more by a disciplined process that anticipates harm before it happens. Two...
- Analytical Versus Clinical Validation: How Software as a Medical Device Earns Trust
The internationally used framework for Software as a Medical Device asks three separate questions: whether the software's output is scientifically linked to the...
- What Happens to a Software Medical Device After Launch
A software medical device is not finished when it ships. Launch is the moment its obligations begin, because the population it serves keeps changing, clinical...
- When Is Clinical Decision Support a Regulated Device? The Line, Explained
The short answerIn the United States, a piece of clinical decision support software falls outside the FDA's device authority only when it meets all four criteria...
- The FDA De Novo Pathway: How a Genuinely New Device Finds a Route to Market
The short answerThe De Novo pathway is how the FDA classifies a medical device that is genuinely new, poses low to moderate risk, and has no earlier device it can...
- The EU AI Act and Medical Software, in Plain Terms
The EU AI Act is a horizontal law that sorts artificial-intelligence systems by how much risk they pose, and most software that helps make a clinical decision lands...
- The IVDR in Plain Language: How Europe Regulates Diagnostic Tests
The EU In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) is the law that governs how diagnostic tests reach the European market, from a home pregnancy...
- What a Notified Body Does in CE-Marking a Medical Device
What is a notified body?A notified body is an independent organization that the European Union authorizes to check whether a higher-risk medical device meets the...
- What a Regulatory Submission for a Medical Product Actually Contains
What goes into a regulatory submission for a medical product?A regulatory submission is the organized argument that a medical product is safe enough, works as...
- What Good Clinical Practice Requires, and Why Trials Live or Die by It
Good Clinical Practice, usually shortened to GCP, is the international ethical and scientific standard for how human clinical trials are designed, conducted,...
- What ICH E6(R3) Changed in Good Clinical Practice, and Why 2025 Was a Turning Point
The renovated Good Clinical Practice standard, ICH E6(R3), was adopted at Step 4 of the ICH process on 6 January 2025, and the U.S. Food and Drug Administration...
- What Orphan Drug and Rare Disease Pathways Do
Orphan drug and rare disease pathways are the incentive frameworks that regulators built to make an unprofitable kind of medicine worth developing. A rare disease...
- When a Health System Uses an Algorithm: The Nondiscrimination Duty
When a hospital or a clinician uses a clinical algorithm to help make a care decision, a federal nondiscrimination duty attaches to the user, not only to whoever...