Bringing medical devices to market
- Publication/Creation:
- Chicago, Illinois: American Bar Association, Health Law Section, [2021]
- Resource Type:
- Book
More Details
Additional/Related Title Information
- Full Title:
- Bringing medical devices to market / Charlene Cho, editor
Related Names
- Additional Author/Creators:
- Cho, Charlene, editor
American Bar Association. Health Law Section, sponsoring body
Subjects/Genre
- Genre:
- Legal forms
- Subjects:
- Medical instruments and apparatus--Law and legislation--United States
Medical technology--Law and legislation--United States
New products--Law and legislation--United States
Description/Summary
- Table of Contents:
- FDA premarket requirements / Vernessa T. Pollard and Anisa Mohanty -- FDA regulation of digital health care products / Jeffrey N. Gibbs and Allyson B. Mullen -- Data, clinical trials, and good clinical practices / Gerard Prud'homme, Kristen Zielinski Duggan, Megana Sankaran -- Intellectual property protections for medical devices / Ed Buthusiem, Jeffrey Klenk, and Eric Carlson -- Business arrangements and contractual agreements / David Hatch and Robert Miller -- Postmarket requirements / Paul Gadiock and Jamie Ravitz -- Compliance and enforcement / Paul Gadiock and Jamie Ravitz -- Import/exports / Allison Fulton -- Fraud and abuse laws / Charlene Cho and Jennifer Michael -- Coverage, coding, and reimbursement for medical devices / Beth Halpern, with Mahmud Brifkani, Boyd Jackson, Soraya Keskey, and Maria Malas -- AI--products liability / Terrence Dee.
- Summary:
- "Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"--
- Language:
- English
- Physical Type/Description:
- xxx, 389 pages : forms ; 23 cm
- Local Note:
- GOBI Library Solutions from EBSCO
Additional Identifiers
- Catalog ID (MMSID):
- 9937469190602486
- ISBN:
- 9781641059701
1641059702 - OCLC Number:
- 1267411885
- Barcode:
- 200000220555
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