Author: Devin McElroy

Consent Decrees
July 6, 2017
By Devin McElroy

The FDA, this morning, issued a press release for a consent decree issued against Medistat by a U.S. District Judge (see attached article for details). What is a consent decree and what actions cause one to be issued? A consent decree is requested by the FDA and issued by a Federal Judge against a company that has had numerous, unresolved violations against U.S. regulations for medical device or pharmaceutical manufacturing. Typically this process starts years before with a series of FDA Form 483 (Notice of Inspection) findings issued against a

The Impact of Brexit on the U.S. Medical Device Industry
October 14, 2016
By Devin McElroy

There are a few anxieties by U.S. medical device manufacturers concerning the projected exit of Great Britain from the European Union. 1. Does GB allow the U.S. to import devices bearing the CE-Mark? 2. Do Member states within the EU allow imported medical devices having a British Notified Body such as BSI & SGS? 3. Does the British Health care system include reimbursement changes? 4. Does GB generally allow the import of any product from any foreign country? Let’s focus on these concerns. The CE-Mark is global, with the exception