A competitor's 513(g) leaves no trace

Section 513(g) of the Food, Drug, and Cosmetic Act gives any person a narrow, specific right: ask FDA, in writing, how a particular device is classified and what the Act requires of it, and FDA must answer within sixty days. No submission fits that description anywhere in FDA Radar’s own coverage — not because the product misses it, but because FDA’s own procedures keep the question and the answer out of every place a monitoring product, or anyone else, could read them.

What the statute actually gets you

A 513(g) request, formally a Request for Information, is not a path to clearance or approval. FDA’s own guidance on the mechanism is explicit that a response “is not a classification decision and does not constitute FDA clearance or approval for commercial distribution of a product” — it is FDA’s written view of where a device sits in the existing classification framework, addressed to whoever asked, and it carries a standard user fee under Section 738 of the Act. What it buys is speed and specificity: a statutory sixty-day clock, on a question a company might otherwise spend months answering by reading analogous 510(k) files and guessing.

Where the record goes

Compare that to a 510(k) clearance, which lands in openFDA’s public dataset the day FDA decides it — the record this blog has described from a dozen different angles, because it is genuinely there to read. A 513(g) request and FDA’s written response to it are neither. FDA’s own procedures for the program treat both as confidential: not posted to regulations.gov the way a comment or a petition would be, not entered into openFDA the way a clearance is, not searchable anywhere in FDA’s public inventory of submissions. A competitor can ask FDA exactly how their device is classified, get an answer inside two months, and leave nothing for anyone outside that exchange to ever find.

A reclassification petition is public the day it arrives and silent about its outcome. A 513(g) request is silent from the moment it’s filed — there is no public record to watch for either end of it.

The practice

Don’t read the absence of a competitor’s 513(g) activity as evidence they haven’t asked FDA a classification question about their own device — the mechanism is built to leave nothing for a product-code watch, or any other public search, to find. For your own program, a 513(g) buys a fast, informal answer with no public trail; a 510(k) submission is slower but eventually lands in the dataset FDA Radar reads. Which one fits a specific classification question is a judgment for a regulatory professional working the file — this is regulatory intelligence about where an answer can and can’t be found, per FDA Radar’s editorial standards, never advice about which mechanism to use.