- device classification,
- predicate selection,
- the table of contents,
- team member selection,
- planning performance testing, and
- FDA pre-sub meetings.
Rob’s first 510k submission, K050769, was received by the FDA on March 25 and the 510k letter was issued on April 14–20 days later. Most 510k letters are not issued this quickly, but with training you can learn to avoid the most common delays:
- failure of eCopy upload,
- Refusal to Accept (RTA), and
- Requests for additional information.
This webinar, presented by subject matter expert, Rob Packard of Medical Device Academy, provides detail related to management of 510k submissions. Recording will be sent in a separate email.
10- Question Exam and Training Certificate available for $49.00:
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
510(k) Medical Device Academy Training Overview – Brief Video
About Your Instructor
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.