Right to try reaches drugs, not devices

A right-to-try request is built to skip something specific: the expanded-access process FDA runs under its own rule, where a sponsor files a protocol and, often, FDA reviews it before a single unit reaches the patient. The federal statute that created this bypass names exactly one kind of product eligible for it — and three years before Congress wrote that statute, at least one state had already written the same kind of law to reach further.

What the federal statute actually names

The Right to Try Act of 2017, Public Law 115-176, added Section 561B to the FD&C Act — codified at 21 U.S.C. § 360bbb-0a. Its definitions cover an “eligible investigational drug”: one that has completed a Phase 1 trial, remains unapproved for any use, and is either named in a pending marketing application or under active study in a trial meant to support one. Every condition in that definition is written around a drug. No parallel term for a device appears anywhere in the section, because the section was never written to reach one.

The same subchapter already had the pairing

Section 561B sits in the same part of the FD&C Act as Section 561 (21 U.S.C. § 360bbb), FDA’s older expanded-access provision — the one a right-to-try request is built to bypass. That section names “investigational drug or investigational device” as a single phrase, repeated through every subsection: emergency authorization, individual patient protocols, widespread treatment protocols. Congress had the device half of that pairing sitting in the next section over when it drafted 561B in 2017, and left it out. A device seeking the same kind of individual-patient access still goes through Section 561 itself — through FDA, under a treatment IDE or one of its narrower variants — because no statute ever built it the direct-from-manufacturer route a drug now has.

Section 561 names a drug or a device, every time it speaks. Section 561B, written to let a patient route around Section 561 entirely, speaks only of a drug.

A state already covered both, years earlier

Nevada signed its own right-to-try law in 2015, Assembly Bill 164, now NRS § 454.690. Its own definition covers an “investigational drug, biological product or device” — all three, three years before the federal version existed at all. Nevada was not extrapolating from a federal model that hadn’t been written yet; it built the broader version first, on its own, the way dozens of states did in the years before Congress acted. When Congress finally wrote the federal statute, with every one of those state laws already public, it still chose the narrower of the two scopes already sitting in front of it.

The practice

A device reaching a patient through a state right-to-try law, where one exists, never touches an IND, an IDE, or any FDA filing at all — the entire point of these laws is that FDA is not part of the transaction. Nothing about that access would ever surface in MAUDE, in a 510(k) or PMA record, or in any other FDA database, and no monitoring feed, this one included, reads a state legislature’s own statute book as a source. Per what we monitor and how often, FDA Radar’s pipeline starts and ends at FDA’s own public record — a use case this far outside it is simply not visible from here. This is regulatory intelligence about what two overlapping statutes actually say, never advice about using either one to obtain treatment.