By Jeffrey K. Shapiro – FDA is authorized by the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA) to regulate the labeling of all medical devices and the advertising only of “restricted devices.” (21 U.S.C. §§ 352(a), 352(q) and (r).) FDA does have …
FDA’s 510(k) review is based upon the concept of substantial equivalence. This approach has been much criticized, but in a new article published in the Food and Drug Law Journal and authored by Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro, Mr. Shapiro concludes …
By Jennifer D. Newberger – On August 19, 2014, FDA finalized its guidance document, “FDA Decisions for Investigational Device Exemption Clinical Investigations,” which was issued in draft in June 2013. The final guidance is largely similar to the draft, with the exception of the pre-decisional IDE …
By Jennifer M. Thomas & Anne K. Walsh – French device maker PREVOR won another victory against FDA in litigation involving FDA’s interpretation of the statutory definition for “device.” The first suit, as readers may recall (see our previous post here), resulted in a finding from …
By Jennifer D. Newberger – On August 20, 2014, CDRH issued a guidance document, “Unique Device Identifier System: Frequently Asked Questions, Vol. 1.” The purpose, according to the guidance, is to “provide[] clarification of key provisions of the UDI Rule.” We previously posted on the UDI rule …
By Jennifer D. Newberger – On August 14, 2014, FDA issued a draft guidance titled, “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (draft guidance). The de novo review process, formally known as Evaluation of Automatic Class III Designation, is established by section 513(f)(2) of …
By Jennifer D. Newberger — We previously posted about CDRH’s guidance on the appeals process contained in the Food and Drug Administration Safety and Innovation Act (FDASIA), and its issuance of a draft Q&A discussing section 517A. Section 517A imposed timeframes for appeal decisions that were …
By Allyson B. Mullen & Jeffrey N. Gibbs — On July 31, 2014, in accordance with Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of laboratory developed tests …
By Allyson B. Mullen — On July 28, 2014, FDA issued the final guidance document “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” The draft of this guidance was issued on December 27, 2011 (see our earlier blog post here). Very little has changed …
By Alexander J. Varond — FDA recently released its report entitled “Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases Including Strategic Plan: Accelerating the Development of Therapies for Pediatric Rare Diseases.” The report fulfills the …
By James E. Valentine* — On July 15, 2014, FDA announced the availability of a draft guidance, titled “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors” (“FDA Draft Information Sheet”). When final, it will replace the Agency’s informed consent 1998 Information Sheet, “A Guide …
By Jeffrey N. Wasserstein – On July 2, 2014, five U.S. Senators sent a letter to the head of the Office of Management and Budget (“OMB”) urging OMB to release a draft guidance proposed by the U.S. Food and Drug Administration (“FDA”) relating to the regulation …
By Jamie K. Wolszon – In the past two months we have seen two newsworthy items in the Laboratory-Developed Test (“LDT”) world. In June, the Defense Health Agency (“DHA”) announced that TRICARE, the U.S. health care program serving Uniformed Service members, retirees and their families, has …
By Jennifer D. Newberger – Recognizing that even regulating certain software products as Class I medical devices is more regulation than necessary, FDA released a Draft Guidance document titled, “Medical Device Data Systems [MDDS], Medical Image Storage Devices, and Medical Image Communication Devices.” This Draft Guidance …
By Allyson B. Mullen – As part of the Medical Device User Fee Act of 2012 ("MDUFA III") Commitment Letter, FDA and the medical device industry agreed to participate in a comprehensive outside assessment of the medical device review process. The assessment was performed by Booz …
