Reading path

How Regulation Decides What Reaches Patients

Every drug and device a patient uses had to clear a regulator first, and those rules are not arbitrary. This path walks you through how evidence standards, market pathways, and post-market checks fit together, so you can tell what a clearance or an approval actually promises. By the end you will be able to look at a regulatory label and know what kind of evidence stands behind it.

The path, step by step

1. 1 How Regulators Grade Clinical Evidence, and Why the Bar Moves With Risk

   5 min read

   Start here, because the single principle that organizes everything else is that the evidence bar rises with the risk a product carries.

2. 2 How Much Evidence Proves a Drug Works? Two Trials, One Trial, or One Plus Confirmatory Evidence

   4 min read

   With that principle in hand, see how it plays out for drugs, where full approval can rest on two trials, one trial, or one trial plus confirmatory evidence.

3. 3 Predicate Devices and Substantial Equivalence, Explained for Medical Software

   5 min read

   Devices follow a different logic than drugs, and this explains the common clearance route that lets a new device lean on one already on the market.

4. 4 The FDA De Novo Pathway: How a Genuinely New Device Finds a Route to Market

   5 min read

   When a device is genuinely new and has no predicate to match, this shows how it earns a route to market on its own evidence rather than by comparison.

5. 5 CE Marking Versus FDA Clearance: Two Routes a Medical Device Takes to Market

   5 min read

   Now widen the lens to two regions at once and see why a US clearance and a European CE mark can signify very different things about the same product.

6. 6 EU MDR and Software as a Medical Device, in Plain Language

   4 min read

   Software is the hardest case to regulate, so this grounds the European rules for it, including how MDR, IVDR, and the idea of software as a medical device fit together.

7. 7 The Accelerated-Approval Bargain: Surrogate Endpoints, Confirmatory Trials, and Faster Withdrawal

   5 min read

   Some products reach patients faster on a surrogate endpoint, and this is the bargain that trades earlier access for a confirmatory trial that has to follow.

8. 8 How Post-Market Surveillance Works: Watching a Device After It Reaches Patients

   5 min read

   Clearance or approval is not the finish line, and this shows how regulators keep watching a product once real patients are using it.

9. 9 Real-World Evidence in Regulation: What Data Outside a Trial Can and Cannot Decide

   5 min read

   Close the loop by learning what data gathered outside a trial can and cannot decide once a product is in everyday use.

Each step is a full article on the Reading the Evidence blog.

Back to all reading paths