Cardiac Lunch Michael A. Swit, Esq. Vice President

2 Standard Disclaimers Views expressed here are solely mine and do not reflect those of my firm or any of its clients. This presentation supports an oral briefing and may not be relied upon solely on its own to reach any conclusion of law or fact.

3 “Global” Environment Obama Administration – what does it foretell –Universal health care …? FDA Issues –New commissioner – who, biases/predilections Sharfstein – ex-Waxman staffer Califf – Duke – cardiologist; head of Duke Clinical Research Institute – colleagues, e.g., Mitchell Krucoff; significant experience with CV devices

4 FDA Environment CDRH – under fire by Capitol Hill – coercion of reviewers by upper management – impact??? –Changes at the top? CDRH Director– staying? House in New Mexico ODE Director – also “implicated” –Disruption of review process –A prolonged Congressional inquiry can be very disruptive in general as diverts resources –Pressures FDA to be much more conservative – e.g., device companies may be required to submit IDEs and resultant clinical data to support the 510(k) process Alpert – agrees -- more data less risk tolerance.

5 Device Approval/Marketing Issues 510k Process –GAO report – required by FDAAA Includes a focus on FDA’s failure to require PMAs or reclassify a number of pre-’76 devices in CV area as required by the 1990 Safe Medical Devices Act –Types: »external pacemaker pulse generator ( ), »Permanent pacemaker electrodes ( ) »External cardiac compressor ( ) »AED – automated external defibrillator ( ) »Nonroller-type cardiopulmonary bypass blood pump ( ) –Class III devices being cleared under 510k – 27 % were CV devices –If put in Class III, PMA’s will be needed Focuses on “High risk device” should be under PMA New intended uses – only found in 1% of 510k’s New tech. characteristics – only found in 15%

6 Device Approval/Marketing Issues … Anticipate more demand for clinical data for Class II devices Clinical studies – already hard; could get harder –Proposed Physicians Sunshine Act would require physicians to post the disclosure on a federally run website and if they do not file the fine is pretty hefty. $10,000/day. Disincentive to be an investigator? Inspections – there is legislative language on Capitol Hill that would require an inspection for every 510k

7 FDA Concerns – Devices in General Submission Issues –Normative data Quality Issues -- Compliance –Design controls –Software processes and validation –Foreign facilities – if you have them, make sure they are up to snuff – import detention is too easy

8 Post-Market Issues Expect more post market requirements Expect greater scutiny of MDRs as issues. Mandatory registries are an initiative that may be the problem Preemption – keep an eye on Congress

9 Unique Device Identification FDA has published a notice in the Federal Register announcing a Public Workshop on 12 February 2009 and requesting comments on a number of UDI related issues. Please see: Docket No. FDA-2008-N-0661, CDRH Unique Device Identification System; Public Workshop; Request for Comments. Comments due February 27, 2009.Docket No. FDA-2008-N-0661, CDRH Unique Device Identification System; Public Workshop; Request for Comments Upcoming Meeting: FDA Unique Device Identification Public Workshop: February 12, 2009FDA Unique Device Identification Public Workshop: February 12, 2009 On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 was signed into law. This act includes language related to the establishment of a Unique Device Identification System. This new system when implemented will require: –the label of a device to bear a unique identifier, unless an alternative location is specified by FDA or unless an exception is made for a particular device or group of devices. –the unique identifier to be able to identify the device through distribution and use –the unique identifier to include the lot or serial number if specified by FDA

10 An Invitation Webinar – tomorrow morning – Ten Chief Obstacles to Meeting Your Development Milestones – 8 am PT –

11 Call, , fax or write: Michael A. Swit, Esq. Vice President, Life Sciences THE WEINBERG GROUP INC. 336 North Coast Hwy. 101 Suite C Encinitas, CA Phone Fax Cell Questions?

12 About your speaker… Michael A. Swit, Esq., is a Vice President at THE WEINBERG GROUP, where he develops and ensures the execution of a broad array of regulatory and other services to clients, both directly and through outside counsel. His expertise includes product development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food and dietary supplement industries. Mr. Swit has been addressing critical FDA legal and regulatory issues since His multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius. Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars.

13 For twenty –five years, leading companies have depended on THE WEINBERG GROUP when their products are at risk. Our technical, scientific and regulatory experts deliver the crucial results that get products to market and keep them there. Washington ♦ New York ♦ San Francisco Brussels ♦ Edinburgh