Medical Devices Compliance 2016 in USA

Overview:

Have you had the experience of guiding a new product through concept, development, and final design, and, while you are preparing the product for US introduction, you suddenly stop dead. It seems FDA has decided your product is a medical device!

The basic definition of a medical device is extremely broad, including "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease..." If the product’s intended us has some relationship to health, and the product is not a drug, it's possible to define it as Medical Device.

Why should you attend?

Fortunately for publishers, medical textbooks and medical journals have not yet been considered to be medical devices. What has been determined to be medical devices by FDA are laboratory developed tests, and stand-alone software that keeps track of patient’s condition, that is, LIMS and Electronic Health Records. If you are developing, or considering developing, or considering financing development, you need to have some basic understanding of US medical device law, and this 1.5 day session is designed to give you that.

Who will benefit:

• People who are working in non-regulatory or QA areas of medical device companies
• People who are interested in starting a company to sell health-related products
• People who are interested in financing a health care company
• People who are interested in selling medical devices

 Agenda:

Day 1 Schedule:

Lecture 1: What is a device?

• How can you tell if your product is a medical device
• Regulation and guidance and the role of each
• Determining your classification

Lecture 2: Pre-market

• Design control
• Pre-submission meetings

Lecture 3: Marketing submissions

• PMA
• 510(k)
• De novo

Lecture 4: The "different" products

• Combination Products
• IVDs and LDTs
• Software

Day 2 Schedule:

Lecture 1: Clinical Trials

• IDE
• Other
• Export for trials
• Common problems in trial design and management

Lecture 2: Post marketing

• QSR
• CAPA
• Reporting
• Inspections
• Export for foreign markets

Lecture 3: Pop quiz

• Give quiz
• Discuss questions and answers

Lecture 4: Questions 30 min

Speaker:

Principal, Longwell and Associates 

Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams. Prior work experience included a division of BD investigating monoclonal antibodies as therapy, and Alza Corporation during the period when they pioneered combination products. She has been a visiting lecturer in food and drug law at the University of Santa Clara school of law, a visiting lecturer in food law at the Institute of Agribusiness, University of Santa Clara School of Business, a visiting lecturer in regulatory topics at the Haas School of Business, UC Berkeley, and the UC Santa Cruz Extension (UCSC), and an instructor for the Food and Drug Law Institute (FDLI) internship program at Catholic University, Washington DC. Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled "Due Diligence Points to Consider" in the "Expert's Guide to Healthcare Product Due Diligence" published by FDLI.

Ms. Longwell holds a bachelor's degree in Chemistry from San Francisco College for Women (now USF), a Master's degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively. She is a current member of the California Bar (#166040) and the US Patent bar (#50629).

Location: San Diego, CA Date: October 13th & 14th, 2016 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 

Until September 10, Early Bird Price: $1,295.00 from September 11 to October 11, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Until September 10, Early Bird Price: $6,475.00 from September 11 to October 11, Regular Price: $7,475.00

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