SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 26, 2011
MELA Sciences, Inc.
(Exact name of registrant as specified in its charter)
Registrants telephone number, including area code (914) 591-3783
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
Item 8.01 Other Events
On September 26, 2011, MELA Sciences, Inc. (the Company) issued a press release announcing that the U.S. Food and Drug Administration (the FDA) has issued an Approvable Letter for the MelaFind® Pre-Market Approval (PMA) application. The Company intends to work with the FDA to finalize the physician and patient labeling, package insert, users guide, training program and clinical protocol for a post-approval study in order to obtain final approval. A copy of the press release is attached as Exhibit 99.1 to this current report.
Item 9.01 Financial Statements and Exhibits
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.