Medical Devices

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 …
CDRH Issues Joint FDA/FTC Promotion and Advertising Untitled “Email” to On-line Distributors; Uses Unprecedented Approach to Warn of Possible Criminal ProsecutionMarch 7th, 2013
By Carmelina G. Allis – On February 28, 2013, FDA’s Center for Devices and Radiological Health (“CDRH”) issued what appears to be an unprecedented joint FDA/Federal Trade Commission “untitled letter” in the form of an email (an “untitled email”) to on-line distributors of decorative contact …
Medical Device Recall or Product Enhancement? FDA’s New Draft Guidance Should Be Recalled for Significant RepairsFebruary 28th, 2013
By Jeffrey K. Shapiro – FDA has just issued a draft guidance document titled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements” (Docket No. FDA-2013-D-0114) intended to clarify how to distinguish product “corrections” from product “enhancements.” Although the draft guidance would be applicable …
FDA Issues Proposed Rule Affecting Acceptance of Data from Medical Device Clinical StudiesFebruary 25th, 2013
By Jennifer D. Newberger – FDA issued a proposed rule to amend its regulations on acceptance of data from medical device clinical studies. The primary proposed changes include: Requiring that clinical studies conducted outside the United States to support any submission to FDA, including a 510(k) or …
FDA Issues Draft Guidance, Proposed Rule Regarding Submission of Information on Pediatric Use of Medical DevicesFebruary 24th, 2013
By Jennifer D. Newberger – The Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to require certain medical device submissions to include, “if readily available – (A) a description of any pediatric subpopulations that suffer …
FTC’s Interest in Mobile Apps IntensifiesFebruary 22nd, 2013
By Carmelina G. Allis – As reported in FTC Watch Issue No. 823 (Feb. 13, 2013), the Federal Trade Commission has plans to increase enforcement actions against mobile apps – including mobile medical apps. During a Consumer Protection Conference sponsored by the American Bar Association earlier …
First Fruits of FDASIA’s New Device Reclassification ProcedureFebruary 17th, 2013
By Jeffrey K. Shapiro – We are seeing the first fruits of a new device reclassification procedure added last summer to the Federal Food, Drug, and Cosmetic Act (“FDCA”). The new procedure modifies Section 513(e) of the FDCA to make it easier for FDA to reclassify …
Caronia Webinar – Slides and Audio Available for DownloadFebruary 8th, 2013
On January 31, 2013, Hyman, Phelps & McNamara, P.C. presented a webinar addressing the real-world implications from the Second Circuit decision in United States v. Caronia. Panelists addressed the potential impacts to the pharmaceutical, devices, dietary supplements, and tobacco industries. HP&M was quite pleased that …
FDA Finalizes Guidance on Humanitarian Use Device DesignationsJanuary 29th, 2013
By Jennifer D. Newberger – On January 24, 2013, FDA finalized the Humanitarian Use Device (HUD) Designations guidance, issued in draft on December 13, 2011. The guidance addresses HUD requests, a first step in obtaining approval of a Humanitarian Device Exemption (HDE). A HUD is a …
FDA Issues Final Rule on CGMP Requirements for Combination Products; Requirements for “Convenience Kits” DefinedJanuary 24th, 2013
By Carmelina G. Allis – The FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. 78 Fed. Reg. 4307 (Jan. 22, 2013). This rule finalizes a proposed rule issued on September 23, 2009. The new rule, …

Search FDA Law Blog

Subscribe

Latest Tweets

Awards & Honors