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FDA Medical Device Industry Coalition presents

Medical Devices 101: An Educational Forum

Date and Time: August 26, 2019 from 8 a.m. to 5 p.m.

Location: MedtoMarket, 2101 East St. Elmo Rd. Bldg 1 Ste 100, Austin, TX  78744

Contact: Jonnetta Wheaton, FDA Medical Device Industry Coalition Communications Chair, email: jonnetta.wheaton@dshs.texas.gov             

Registration: $150. To register online, please visit Online Registration.

If you need special accommodations due to a disability, please contact Jonnetta Wheaton (see Contact) at least 7 days in advance.

This educational forum is intended for folks with little experience with FDA for medical device manufacturers, specification developers, and initial distributors of imported devices. Useful to entrepreneurs, very small start-up companies, new hires, students planning a career in the medical device industry or enforcement, and administrative and marketing employees. The FDA regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the US. Regulatory Control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); with most Class III devices require Premarket Approval.

The basic regulatory requirements: Establishment registration, Listing, Premarket Notification 510(k), unless exempt, (PMA), Investigational Device Exemption (IDE) - clinical studies, Quality System (QS) regulation, Labeling, Medical Device Reporting (MDR)

Speakers: Beckie Ellis, VP RA/QA Argon Medical Devices – Industry; Dr. John Criscione - Texas A&M, Professor Biomedical Engineering; William “Bill” Shackelford, Supervisory Consumer Safety Officer - FDA




Last updated May 14, 2020