The following documents were submitted to the FDA from 1997 through 2001 regarding the "Nevyas Investigational Laser"
The laser was built by Ed Sullivan who, according to the excerpt below, was already under scrutiny by the FDA: "Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him "clearly as a manufacturer with multiple manufacturing sites" subject to FDA rules and regulations and, if he makes another one of these excimer lasers "which are unapproved devices," he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement." [as written in The Journal of Refractive Surgery - Volume 11 (5) * September/October 1995 * News and was found at the url address: http://www.slackinc.com/eye/jrs/vol115/news1.htm">http://www.slackinc.com/eye/jrs/vol115/news1.htm (no longer available).
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NOTES: Page numbers with an "l" designate the page as landscape. All BLUE font on this page designate links. Some PDF documents may require a decrease in magnification for better clarity.
To view ALL DOCUMENTS listed below in one PDF (two parts), click HERE.
PAGE 1 - Prohibition of promotion and other practices. - 21 CFR. § 812.7
PAGE 2 - Protocol NEV-97-001: Myopia with or without astigmatism - Study Procedures.
PAGE 3 - Protocol NEV-97-001: Inclusion/Exclusion Criteria.
PAGE 4 - IDE Supplement - Question/Response.
PAGE 5 - Protocol NEV-97-001: Ethical and regulatory considerations.
PAGE 6 - Protocol NEV-97-001: Complications, Adverse Events, & Serious/Unanticipated Adverse Device Effects.
PAGE 7 - Protocol NEV-97-001: Inclusion/Exclusion Criteria Revision.
PAGE 8 - Protocol NEV-97-001: Screening for Refractive Surgery Eligibility.
PAGE 1 - PAGE 2 - PAGE 3 - FULL - Protocol NEV-97-001: Study Changes, Progress towards PMA Approval, Safety & Efficacy for Study Eyes (Notice the 100% for cumulative UCVA of 20/40 or better, the 0 counts for the BSCVA worse than 20/40 or better, or for the BSCVA worse than 20/25, 6 months after my surgery).
PAGE 1 - PAGE 2 - FULL - The FDA states "We continue to be concerned that your ablation is likely to have multifocal properties, which means that some light will be out of focus even at tine best focal plane".
PAGE 1 - PAGE 2 - PAGE 3 - FULL - Safety & Efficacy for Study Eyes, Page 1 (Notice the 100% for cumulative UCVA of 20/40 or better, the 0 counts for the BSCVA worse than 20/40 or better, or for the BSCVA worse than 20/25, 1 1/2 years after my surgery). The charts on pages 2 and 3 also do not show adverse events or complications.
PAGE 1 - The FDA states "There was no documentation to show that the CI notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements] prior to implementation"; "The firm is not complying with the Investigator Agreement which was signed and dated by the Clinical Investigator at the beginning of the Clinical Study"; and "There was a lapse of IRB approval for the protocol: NEV-97-001 from 8/3/2000 until 8/29/2000 according to IRB, lapse notices and the IRB annual reapproval letter".
Anita Nevyas' Promotion of An Investigational Device
Guidelines, regulations, and laws were in effect prior to the Nevyases'; investigational study.
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From the Federal Trade Commission:
PAGE1 - PAGE2 - FULL - The FTC enforces the Federal Trade Commission Act (FTC Act), which among other things prohibits deceptive or unfair practices in or affecting commerce. 15 U.S.C. §§ 45, 52-57. An advertisement is deceptive under Section 5 of the FTC Act, and therefore unlawful, if it contains a representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances, and that representation or omission is material, that is, likely to affect a consumer's choice or use of a product or service. It is important to note that advertisers are responsible for claims that are reasonably implied from their advertisements, as well as claims that are expressly stated.
In addition, under the FTC Act, advertisers must have substantiation for all objective claims about a product or service before the claims are disseminated In the context of claims about the safety, efficacy, success or other benefits of RK or PRK, substantiation will usually require competent and reliable scientific evidence' sufficient to support the claim that is made.
From the Food and Drug Administration (FDA):
PAGE1 - PAGE2 - FULL - As you know, the FDA approved applications for premarket approval (PMAs) from Summit Technology, Inc. and from VISX Inc_ for their excimer lasers for the correction of mild to moderate myopia in patients with minimal astigmatism Based on the submitted data, these models were approved for refractive correction only by photorefractive keratectomy (PRK) of the corneal surface. Data were not submitted to support the use of these lasers for laser assisted in-situ keratomileusis (LASIK), laser scrape, astigmatism, hyperopia, or multipass or multizone software algorithms. Currently, these are the only lasers approved by FDA for refractive correction and the only refractive indications for which they are approved. The dioptric ranges indicated in the PMA are based on data submitted by these companies in their applications. Data on higher myopia and astigmatism were not submitted, and therefore the approvals did not provide for their treatment. All other lasers being used for refractive surgery, however manufactured or obtained, should be regarded as investigational devices and patients should have the usual human subject protection of institutional review board (IRB) protection, informed consent and an IDE approval by FDA.
21 C.F.R. §§ 812.7 Prohibits promotion of an investigational device!
21 C.F.R. §§ 812.7
CODE OF FEDERAL REGULATIONS
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SUBCHAPTER H--MEDICAL DEVICES
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
SUBPART A--GENERAL PROVISIONS
§§ 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:
(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling.
(c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.
(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.
However, the Nevyases DID promote:
And in an infomercial on MDTV: