Medical Devices

CDRH Issues Draft Guidance on Substantial Equivalence DeterminationsDecember 29th, 2011
By Jennifer D. Newberger – To finish out a year in which the Center for Devices and Radiological Health ("CDRH") issued what appeared to be an unprecedented number of draft guidance documents, CDRH issued two more on December 27, 2011. This blog post discusses one such …
GAO Reports on Approval of Pediatric Medical DevicesDecember 22nd, 2011
By Jennifer D. Newberger – The Government Accountability Office (“GAO”) recently issued a report on pediatric device development. The report “(1) describes barriers to developing pediatric devices, (2) describes how pediatric device consortia have contributed to the development of pediatric devices, and (3) examines FDA data …
Medical Device Patient Safety Act Introduced in the Senate; Bill Would Allow for Recall Tracking and Conditional ClearancesDecember 18th, 2011
By Jennifer D. Newberger – On Thursday, December 15, 2011, Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Herb Kohl (D-Wis.) introduced the “Medical Device Patient Safety Act.” This bill contains two distinct proposals: (1) to give FDA the authority to track and trend device recalls, …
Senator Brown Proposes Modifications to the De Novo ProcessDecember 6th, 2011
By Jennifer D. Newberger – On December 5, 2011, Senator Scott Brown (R-MA) introduced S. 1943, the “Novel Device Regulatory Relief Act of 2011.” The bill is intended to amend section 513 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process …
Examination of MDR Reporting Criteria Warranted in Light of Recent Warning LetterNovember 29th, 2011
By Jeffrey K. Shapiro – In our continuing quest to enlighten, we are launching today an occasional series that will examine significant or interesting warning letters involving medical device companies. As you probably know, FDA issues warning letters to allege violations of the Federal Food, Drug, and …
Senators Propose Legislation to Allow for Profits on Devices for Rare Diseases, Lifting Limitations on Experts to Serve on Advisory PanelsNovember 17th, 2011
By Jennifer D. Newberger – On Tuesday, November 15th, Senator Al Franken (D-MN) announced the introduction of S. 1865, the “Patient Access to Medical Innovation Act.” The bill is intended to accomplish two goals: first, to allow manufacturers of products granted a humanitarian device exemption ("HDE") to profit …
CDRH Issues SOP to Define the Appropriate Management Decision Level for Making Changes to Data Requirements for Premarket SubmissionsNovember 16th, 2011
By Carmelina G. Allis – A persistent industry complaint is that CDRH too often changes data requirements in the middle of a review, or requires data for a new device that was not required for predicate devices. It appears that CDRH has taken a step toward addressing …
FDA Issues Report on Medical Device QualityNovember 4th, 2011
By Jennifer D. Newberger – On October 31, 2011, FDA issued a report titled “Understanding Barriers to Medical Device Quality.” The report results from an initiative launched by the Center for Devices and Radiological Health (“CDRH”) “to assess and understand gaps in medical device quality.” The …
Burr Amendment to Senate FDA Approps Bill Seeks FDA Approval Time TransparencyNovember 2nd, 2011
By Kurt R. Karst – Earlier this week, the U.S. Senate passed, by a 69-30 vote, H.R. 2112, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012, as part of an omnibus package of three spending measures. The House and Senate …
Congress Proposes to Improve the Device Review Process by Amending the Least Burdensome and Conflicts of Interest Provisions in the ActOctober 25th, 2011
By Carmelina G. Allis – A billhas been introduced in the U.S. Senate, the “Medical Device Regulatory Improvement Act” (S. 1700) to amend the least burdensome and conflicts of interest provisions in Sections 513 and 712 of the Federal Food, Drug, and Cosmetic Act (the Act), respectively, …
Proposed Statutory Change Could Make de novo Process More AppealingOctober 19th, 2011
By Jennifer D. Newberger – On October 14, 2011, Representative Brian Bilbray (R-CA) introduced H.R. 3203, the “Novel Device Regulatory Relief Act of 2011.” This bill intends to amend section 513(f) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process for …
Appealing Premarket Disputes in the Device Center: Reform Is NeededOctober 9th, 2011
By Jeffrey K. Shapiro – A medical device manufacturer in most cases is legally required to obtain 510(k) clearance or premarket application (“PMA”) approval from the Food and Drug Administration’s (“FDA”) prior to commercial distribution. Premarket reviews are conducted under the auspices of the Office of …
FDA Issues Draft Guidance Proposing to Streamline the de novo Classification ProcessOctober 3rd, 2011
By Jennifer D. Newberger – On September 30, 2011, FDA announced the issuance of a Draft Guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation), intended to update and streamline the de novo review process. The de novo review process, formally known as Evaluation of …
Hyman, Phelps & McNamara, P.C. Submits Comments to FDA Objecting to Certain Aspects of Draft RUO GuidanceSeptember 18th, 2011
By Jamie K. Wolszon – On August 31, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted comments to FDA’s June 1 Draft Guidance regarding research use only (“RUO”) products (see our previous posts here and here). Although HPM supports many parts of the Draft Guidance, in its comments, …
Medical Devices Law and Regulation Answer Book 2011–12September 15th, 2011
The Practising Law Institute ("PLI") has released a new Medical Devices Law and Regulation Answer Book 2011–12, edited by Suzan Onel (K&L Gates LLP) and Karen M. Becker (Becker & Associates Consultants). This Q&A guide is intended to orient and guide those new to the …

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