What regulatory filings or FDA clearances exist for NeuroDyne Medical products?

1. Company claims: FDA‑registered facility and GMP compliance, according to NeuroDyne’s sites

NeuroDyne’s official websites repeatedly state the supplement is produced in “FDA‑registered and GMP‑certified facilities” in the U.S., and that batches undergo quality testing to ensure “purity, potency, and consistency” while also noting that the FDA has not evaluated the site’s product claims ^{[1] [2] [3]}. Crunchbase’s company profile likewise describes NeuroDyne Medical Corp. as an “FDA - GMP compliant manufacturer of advanced medical devices,” a short company description that echoes the firm’s manufactured image but does not document specific regulatory approvals or filings ^[4].

2. No documented FDA clearances or filings for NeuroDyne products in the provided reporting

Across the supplied sources there is no explicit record of NeuroDyne Medical submitting a 510(k), PMA, NDA, IND, or receiving FDA clearance/approval for a named product; the only regulatory paperwork and filings shown concern other entities or are general guidance pages from FDA ^{[8] [9] [10]}. Independent critiques and review sites note that NeuroDyne’s promotional material can blur the line between manufacturing registration and product approval, and that no human clinical trials specific to the NeuroDyne formula are provided to substantiate therapeutic claims — a point that weakens claims of clinical backing and contributes to confusion about “FDA approval” ^[5].

3. Name collision: Dyne Therapeutics is a different actor with explicit regulatory interactions

A key source of public confusion is the similar name “Dyne.” Dyne Therapeutics (not NeuroDyne) has publicly discussed submitting regulatory filings and has encountered formal FDA interactions — for example, expecting IND submissions, an FDA clinical hold on one candidate (DYNE‑251), and later Breakthrough Therapy Designation activity for DYNE‑101 — all of which are tied to Dyne Therapeutics’ oligonucleotide drug programs, not the NeuroDyne supplement described on retail sites ^{[6] [7]}. The reporting supplied makes this corporate distinction but also implicitly warns that name similarity fuels misattribution of regulatory status.

4. What “FDA‑registered facility” and “GMP‑certified” mean — and what they do not imply

FDA registration of a facility typically means a manufacturer has listed its establishment with the FDA and may follow Good Manufacturing Practices; it is not the same as FDA clearance or approval of a product, which requires a device 510(k)/PMA, drug NDA/BLA, or an accepted IND for clinical trials ^{[8] [10]}. The FDA’s device and neurological device pages show multiple regulatory pathways and emphasize classification and pre‑submission engagement — context that clarifies why facility registration is a piece of compliance housekeeping rather than demonstrable evidence of product safety/efficacy authorization ^{[8] [9] [10]}.

5. Bottom line and reporting limits

Based on the provided reporting, NeuroDyne Medical markets a dietary supplement made in FDA‑registered/GMP‑certified facilities (per company statements and profile listings) but there is no source here documenting FDA clearance or approval for a NeuroDyne product, nor published human clinical trials for the specific formula; the similar name and press about Dyne Therapeutics’ regulatory filings adds a risk of misattribution in public discussions ^{[1] [2] [3] [4] [5] [6] [7]}. This summary is limited to the supplied documents; absence of evidence in these sources is not evidence that NeuroDyne has no filings at all, only that none were found or provided in the reporting reviewed.