Colin J. Zick

Colin J. Zick

Foley Hoag LLP

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Latest Posts › Medical Devices

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FDA Issues Draft Guidance on Medical Device Accessories

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” The draft guidance...more

1/23/2015 - Draft Guidance FDA Medical Devices

FDA Releases Final Guidance on the Regulation of Mobile Medical Applications

On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more

10/1/2013 - FDA FDCA Healthcare Medical Devices Mobile Apps

The Physician Payment Sunshine Act Final Rule A Summary Of Key Provisions

On February 1, 2013, Centers for Medicare and Medicaid Services (CMS) published the long-awaited Physician Payment Sunshine Act (Sunshine Act) Final Rule, implementing Section 1128G of the Social Security Act. The...more

2/8/2013 - Affordable Care Act CMS Drug Manufacturers Medicaid Medical Devices Medical Supplies Medicare Payment Records Physicians Sunshine Act Teaching Hospitals

Massachusetts DPH Finalizes Revised “Gift Ban” Regulations: Softens Rules on Meals, Expense Reporting, and Payment of Med Device...

On November 21, 2012, the Public Health Council promulgated final revised regulations relating to the so-called physician gift ban law, Mass. Gen. Laws c. 111N (“Chapter 111N”). Most notably, the revised regulations now...more

11/27/2012 - Medical Devices Physician Gift-Ban Law

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