For 20 years, Mr. Shapiro has represented medical device companies before the Food and Drug Administration (FDA). He assists in both premarket and postmarket compliance matters.
Areas of medical device expertise include:
- Developing premarket regulatory strategy for products
- Assistance with IDE, 510(k), and PMA submissions
- Appeal of premarket decisions such as NSE letters
- Advice in MDR, recall (field action) and QSR compliance matters
- Review of labeling and advertising for compliance
- Advice regarding the regulation of IVD, LDT, IUO and RUO products
- Regulatory due diligence and post acquisition risk mitigation
- Reviewing contracts and security disclosure documents
- Responding to 483s and warning letters
- Jurisdictional disputes with FDA
- Transfer of 510(k) / PMA
Mr. Shapiro also has expertise in combination products and FDA's regulation of human tissue based products (361 HCT/Ps).
Mr. Shapiro is on the Editorial Advisory Board of MDDI and Update magazines. He is also a frequent speaker at medical device and diagnostic seminars and conferences.
Mr. Shapiro is a graduate of Brown University (magna cum laude) and the Harvard Law School (cum laude).
- DC Super Lawyers 2014, Food and Drug Practice Area
- Who's Who Legal 2014: Life Sciences
- LMG Life Science Star, FDA, Medical Devices, 2012-2014