Medical Devices

IOM Recommends Replacing 510(k) Clearance Process “As Soon As Reasonably Possible”July 29th, 2011
By Jennifer D. Newberger – On July 29, 2011, the Institute of Medicine ("IOM") released its long-awaited report, “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years.” Both industry and FDA were likely surprised by the IOM’s recommendation: do away with the …
FDA Issues Draft Guidance, “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device”July 26th, 2011
By Jennifer D. Newberger – On July 27, 2011, the Center for Devices and Radiological Health ("CDRH") announced the issuance of a Draft Guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” When finalized, this guidance document will …
FDA Issues Draft Guidance Document on Mobile Medical AppsJuly 24th, 2011
By Carmelina G. Allis – The FDA’s “Draft Guidance on Mobile Medical Applications” is applicable to software products (or “mobile apps”) intended for use on mobile platforms that are handheld in nature, such as, for example, the iPhone® and Android® phones. “Mobile medical apps” are defined …
FDA Issues Draft Companion Diagnostic Guidance; FDA Generally Will Require Approval or Clearance of Diagnostic at Same Time As Approval of Therapeutic if Safety and Efficacy of Therapeutic Depends on DiagnosticJuly 13th, 2011
By Jamie K. Wolszon – FDA announced earlier this week the publication of a much-anticipated draft guidance on in vitro companion diagnostic devices. In the draft guidance, FDA stakes out a policy position that if safe and effective use of a therapeutic depends on a diagnostic, …
Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? DoubtfulJuly 6th, 2011
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
FDA is Sued Over Product Designation Determination; Lawsuit Seeks Device Declaration and to Vacate FDA’s Drug FindingsJune 30th, 2011
By Kurt R. Karst & Jeffrey K. Shapiro – French company PREVOR has filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s determination that PREVOR’s Diphoterine® Skin Wash (“DSW”) is a drug-device combination product with a “drug” primary mode of …
When a 510(k) or PMA Goes Off Track – FDA’s Appeals ProcessJune 14th, 2011
The ability to successfully obtain FDA approval is critical to the success of a medical device. However, sometimes even the most dedicated of efforts fall flat when FDA says “No.” What then? What can you do if FDA says it believes there is not an …
ReGen Biologics Sues FDA Over 510(k) RescissionJune 5th, 2011
By Carmelina G. Allis – The “Menaflex” is a collagen meniscus implant intended to reinforce damaged meniscal soft tissue. ReGen Biologics, Inc. obtained 510(k) clearance for the Menaflex in 2008 as a Class II device. On March 30, 2011, FDA rescinded this clearance. Last week, ReGen …
Draft FDA Guidance Proposes Restricting Research Use Only and Investigational Use Only Reagents Instruments – Document Equates Actual Use with Intended UseJune 2nd, 2011
By Jamie K. Wolszon & Jeffrey N. Gibbs – FDA has issued a draft guidance that would limit the sale and distribution of “Research Use Only” (RUO) and “Investigational Use Only” (IUO) products. (A copy of the Federal Register notice announcing the guidance is available here.) …
FDA Posts on its Website, then Removes, Draft Guidance that would Restrict Research Use Only, Investigational Use Only StatusMay 30th, 2011
By Jamie K. Wolszon – Trade reports recently indicated that FDA intended to issue by the end of May a draft guidance outlining its policy for “Research Use Only” (“RUO”) and “Investigational Use Only” (“IUO”) products such as reagents and instruments. Last week FDA posted on …
FDA’s Warning Letter “Close-Out” Process Is Not WorkingMay 11th, 2011
By Robert A. Dormer – In an August 2009 speech to the Food and Drug Law Institute, FDA Commissioner Margaret A. Hamburg, M.D., emphasized the importance of enforcement (see our previous post here). Among other actions announced by Dr. Hamburg was a warning letter “close-out” process. …
Device Company Seeks D.C. Circuit Review of FDA 510(k) Rescission OrderMay 9th, 2011
By Jamie K. Wolszon – ReGen Biologics, Inc. (“ReGen”) has petitioned the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) to review the Center for Devices and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a …
FDA Updates Guidance Document Regarding Changes that Qualify for a 30-Day NoticeMay 3rd, 2011
By Carmelina G. Allis – Earlier this month, FDA updated the 1998 guidance document regarding changes to a PMA device that may or may not qualify for a 30-Day Notice. This updated document provides new examples of manufacturing changes that may be submitted under a 30-Day …
Clinical & Regulatory Strategies for Combination ProductsApril 25th, 2011
Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro will be giving the state of the industry address at Q1 Productions’ 2nd Annual Clinical & Regulatory Strategies for Combination Products, which is slated to take place in Baltimore, Maryland from July 11-12, 2011. The potential benefit …
FDA Issues Warning Letter for Failure to Submit Animal Study Reports in an IDEApril 6th, 2011
By Carmelina G. Allis – A March 24, 2011 warning letter from FDA cites a rarely invoked provision in the Investigational Device Exemption (“IDE”) regulations. It is not clear whether this warning letter is an outlier or a harbinger of more aggressive inspections by the Division …

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