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510(k)

DTA keeps members informed about any proposed changes to current FDA regulatory policies including 510(k) submissions for medical devices. FDA is regularly looking to revamp and streamline the current 510(k) process. This can often involve a proposed change to electronic paperwork (and notes) filings. 510(k) issues are typically covered in the DTA regulatory e-newsletter. Occasionally, DTA sends out e-mail alerts when important deadlines or notifications are required.

DTA also has product submission experts available who can assist members as they navigate the FDA maze of required paperwork and product safety testing filings including Blix Winston, a past FDA officer who has worked on hundreds of 510(k) product submissions, and Claude Berthoin, who has 25 years of experience in the dental industry.  Claude, a member of the DTA, is also the owner of 510k FDA Consulting, a Florida based regulatory consulting firm.  The company has successfully filed numerous 510(k)s since 1990 for domestic and international clients.  By consulting with these regulatory experts, member companies will shorten the 510(k) submission process and save time and money.

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