By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
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Medical Devices
- Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!June 25th, 2013
- CDRH Issues Draft Guidance for IDE and Pre-IDE ProcessesJune 18th, 2013
By Jennifer D. Newberger – On June 14, 2013, FDA issued a draft guidance, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” to provide clarity around certain IDE decisions, and to introduce a “voluntary program intended to facilitate the development of trial designs that may …
- House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action DeadlinesJune 13th, 2013
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
- FDA Commissioner Calls for More Active FDA Regulation of Laboratory-Developed Tests, and ACLA Promptly Responds with a Petition Opposing FDAJune 5th, 2013
By Jeffrey N. Gibbs, Jamie K. Wolszon & Jessica A. Ritsick – For many years, FDA has wrestled with how to regulate Laboratory-Developed Tests (“LDTs”). FDA Commissioner Margaret A. Hamburg is now renewing FDA’s call for more active FDA regulation of LDTs and touting the …
- The Medical Device Amendments of 1976: The Statute That Went AwryJune 3rd, 2013
By Jeffrey K. Shapiro – The Medical Device Amendments of 1976 (“MDA”), Pub. L. No. 94-295, 90 Stat. 539 (1976), are commonly described as the beginning of the modern era of device regulation. In one sense, this description is absolutely correct. The MDA established for …
- FDA Sends Letter to Mobile App Developer for Failure to Obtain 510(k) ClearanceMay 23rd, 2013
By Carmelina G. Allis – FDA has issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to have a 510(k) clearance for its mobile app, the uChek Urine Analyzer. The app can be downloaded for 99 cents through …
- CDRH Issues Final Appeals Guidance, Q&A About FDASIA Appeals ProcessMay 20th, 2013
By Jeffrey K. Shapiro & Jennifer D. Newberger – As discussed in our prior posts (here, here, and here), the Center for Devices and Radiological Health (“CDRH”) has taken much needed steps to improve the most commonly used appeal process, request for supervisory review, available …
- FDA Announces Public Meeting Regarding Device ModificationsMay 14th, 2013
By Jennifer D. Newberger – In the Federal Register of May 8, 2013, FDA announced a public meeting titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” The notice states that the focus of the meeting will be …
- New Paper Argues 510(k) Program Has Strengths That Critics Have OverlookedMay 13th, 2013
On May 4, 2013, Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro presented a draft paper and slides on the 510(k) medical device substantial equivalence program during a conference on FDA in the 21st Century. The conference was held at the Harvard Law School’s …
- Court Rules that FDA has the Inherent Authority to Rescind a 510(k) Substantial Equivalence Determination if It Does so Within a Reasonable Period of TimeApril 28th, 2013
By Carmelina G. Allis – As we previously reported, ReGen Biologics, Inc. ("ReGen"), which has been acquired by Ivy Sports Medicine, LLC ("Ivy"), filed suit in 2011 challenging FDA’s authority to rescind the 2008 510(k) substantial equivalence determination for the company’s “Menaflex” product, a collagen …
- HP&M’s Jeff Shapiro to Speak at Harvard Law/Petrie-Flom Center Annual Conference on FDA in the 21st CenturyApril 25th, 2013
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is is holding its annual conference on Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts. This year, the conference will focus on FDA and is titled …
- FDA Proposes to Harmonize Medical Device LabelingApril 22nd, 2013
By Jennifer D. Newberger – FDA is proposing to amend the medical device labeling requirements to allow for use of internationally recognized stand-alone symbols explained in an accompanying symbols glossary. The symbols glossary would include a list of each symbol used in the device labeling and …
- CDRH Working to Update Appeals Guidance for Consistency with FDASIAApril 17th, 2013
By Jeffrey K. Shapiro & Jennifer D. Newberger – The medical device appeals process has long been in need of improvement. See our previous posts here and here. There are several ways an entity can appeal a decision of the Center for Devices and Radiological Health …
- Cytori Case Decision Upholds FDA’s Not Substantially Equivalent DeterminationMarch 24th, 2013
By Jeffrey K. Shapiro – The U.S. Court of Appeals for the D.C. Circuit (appeal no. 11-1268) issued a decision last Friday backing up FDA’s denial of 510(k) clearance to two of Cytori’s products, the Celution 700 and the StemSource 900, which are intended to harvest …
- Are All Health and Wellness Mobile Apps Exempt from FDA Regulatory Requirements?March 12th, 2013
By Carmelina G. Allis – With information technology taking on an increasingly important role in the healthcare system, software app developers are focusing their efforts on developing programs intended to facilitate health, wellness, and disease management. Some of these apps are developed for and implemented …