CIMIT: April 2008 Regulatory Affairs Newsletter

April 2008 Regulatory Affairs NewsletterPrint this page

• FDA Panel Recommends LASIK Labeling Changes
• FDA Clears Yulex Patient Examination Glove
• OIVD Gives Advice on Pre-IDE Meetings to Diagnostic Device Firms
• CMS Seeks FDA Input on Medicare Device Coding Applications
• FDA Announces Approval of First Compact Heart Assist Device
• FDA Publishes Draft Clinical Trial Certification Guidance
• House Releases Draft Bill to Improve Device Import Safety
• CMS FY 2009 Inpatient Payment Proposal Includes “Charge Compression Fix”
• FDA Releases Draft Guidelines for Drug-eluting Stents
• FDA and Industry Oppose Potential Legislative 510(k) Reform
• CDRH Staffer Calls for Real World Device Trials
• International Sharing of GMP Inspection Results on the Horizon

FDA Panel Recommends LASIK Labeling Changes
According to FDA’s Ophthalmic Devices Panel, patient labeling for LASIK laser vision correction systems should include graphics of potential visual side effects, such as starbursts and halos. The panel recommended a number of other labeling changes, as well as changes to FDA’s LASIK website. Additionally, in an effort to inform patients fully, the panel recommended that FDA evaluate whether it is possible to include language regarding the potential psychological effects of LASIK. The meeting was held to discuss LASIK quality of life issues in response to patients who have been dissatisfied with the results of the procedure. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Clears Yulex Patient Examination Glove
FDA recently cleared the Yulex Patient Examination Glove, which is made from guayule latex derived from the guayule bush—a desert plant native to the Southwestern United States. Traditional latex is derived from the milky sap of a rubber tree and contains proteins that may trigger allergic reactions, especially after prolonged exposure and repeated contact. The currently available data suggests that, even persons who are highly allergic to traditional latex do not react to guayule latex on first exposure. Additional information is available at www.medicalnewstoday.com.

OIVD Gives Advice on Pre-IDE Meetings to Diagnostic Device Firms
According to FDA’s Office of In Vitro Diagnostic Device Evaluation (“OIVD”), a growing number of diagnostics firms are taking advantage of FDA’s pre-IDE meeting forum. One of the reasons for the uptick in such meeting requests is FDA’s data requirements, which are becoming more stringent, making it critical for firms with cutting edge technologies to approach FDA early to ensure that their studies will be adequate. For an effective meeting, companies should approach FDA with a clear intended use and indications for use that make sense medically, a clear description of the device, a clear idea of the study plan with proposed endpoints, and a description of the planned statistical analysis. FDA has recently expressed frustration over the poor quality of these meetings, noting that problems seem to arise because firms are not consulting with statisticians, medical officers, or regulatory affairs specialists prior to meeting with the agency. Additional information is available at www.thegraysheet.com (paid subscription service).

CMS Seeks FDA Input on Medicare Device Coding Applications
The Centers for Medicare and Medicaid Services (“CMS”) increasingly seeks FDA feedback regarding the clinical claims made by device firms seeking new reimbursement codes for their products. Although such interaction has taken place informally for a number of years, FDA is now increasing its involvement. According to CDRH Director Daniel Schultz, M.D., many companies seeking 510(k) clearance for their products by claiming “substantial equivalence” to previously marketed devices are turning to CMS and boasting the uniqueness of the products in an effort to gain higher reimbursement rates. In many cases, the agencies do not believe that both claims can be supported. Additional information is available at www.thegraysheet.com (paid subscription service).

FDA Announces Approval of First Compact Heart Assist Device
On April 21, 2008, FDA announced the approval of the Thoratec HeartMate II Left Ventricular Assist System for surgical implantation to help the heart pump blood throughout the body. The device uses a continuous flow pump that constantly moves blood with a single spinning rotor, rather than the standard pulsatile pump that stimulates the action of the heart. This design allows the size of the device to be reduced so that it is appropriate for use in women and small men who were previously underserved by the device’s larger predecessors. Additional information is available at www.fda.gov/bbs/topics/NEWS/2008/NEW01820.html.

FDA Publishes Draft Clinical Trial Certification Guidance
On April 17, 2008, FDA released a draft guidance clarifying when companies are required to submit clinical trial certification forms to the agency under the 2007 FDA Amendments Act. In particular, the guidance clarifies that certification is typically not necessary for meeting requests, investigational device exemptions (“IDE”), humanitarian device exemptions (“HDE”), premarket approval (“PMA”) 30-day notices, adverse event reports, and premarket notifications (“510(k)”), which are not supported by clinical data. All comments regarding the draft guidance, which is available at www.fda.gov/oc/initiatives/fdaaa/guidance_certifications.html, should be submitted to FDA within 60 days. Electronic comments can be submitted to www.regulations.gov. Additional information available at www.thegraysheet.com (paid subscription service).

House Releases Draft Bill to Improve Device Import Safety
Leading House Democrats recently released a draft bill entitled the “Food and Drug Administration Globalization Act,” which, if enacted, would grant FDA the power to collect facility registration fees from device manufacturers with foreign facilities, as well as from other medical device importers. The additional revenue generated under this act would be used to improve overseas facility inspections and to bring them in line with domestic facility inspections, which occur every two years. The bill is designed to strengthen FDA’s global oversight of medical devices, drugs, food, and cosmetics through such measures as requiring device labels to indicate the product’s manufacturing country of origin. Additional information available at www.thegraysheet.com (paid subscription service).

CMS FY 2009 Inpatient Payment Proposal Includes “Charge Compression Fix”
The Centers for Medicare and Medicaid Services (“CMS”) seeks to improve the accuracy of payments to hospitals for high-cost devices in fiscal year 2009. Although it did not come as quickly as device manufacturers had hoped, the proposed policy would modify hospital cost reports to differentiate between expensive medical devices and relatively inexpensive medical supplies. In general, a product would be considered a device if used for one patient only, if it contacts human tissue, is surgically implanted or inserted, and remains in the patient after he or she is discharged from the hospital. Conversely, products used incident to a service would be classified as medical supplies for purposes of reimbursement. Additional information is available at www.medicaldevicestoday.com.

FDA Releases Draft Guidelines for Drug-eluting Stents
In the March 31, 2008, Federal Register, FDA announced the release of draft guidelines to aid in the development, testing, and manufacture of coronary drug-eluting stents, which are used to treat blocked heart arteries. These devices have been under close scrutiny from both FDA and the clinical community for the past few years due to concerns over clot formation in some patients. The agency's draft guidance outlines FDA's recommendations for premarket clinical trials and post-market studies, as well as recommendations for the development and content of premarket submissions for drug-eluting stents. The draft guidance, Draft Guidance for Industry on Developing Coronary Drug Eluting Stents, is available at www.fda.gov/cdrh/ode/guidance/6255.html. Additional information is available at www.medicalnewstoday.com.

FDA and Industry Oppose Potential Legislative 510(k) Reform
FDA and the medical device industry expressed concerns over Congress's potential reform of the 510(k) process during a panel discussion at the Food and Drug Law Institute annual meeting in Washington, D.C., held on March 26, 2008. FDA officials claim that the 510(k) process is a "well-oiled machine" and that there is no need for Congressional reform of the program. Critics of the premarket notification program have called for additional testing requirements for devices seeking 510(k) clearance, including a requirement that each new device be tested directly against a predicate device in a randomized trial. However, FDA stressed that the current 510(k) program is flexible, allowing the agency to require more substantial data from manufacturers when necessary to determine whether a device is substantially equivalent to a claimed predicate device. Additional information is available at www.fdalegislativewatch.com.

CDRH Staffer Calls for Real World Device Trials
According to Larry Kessler, the director of the Office of Science and Engineering Laboratories at FDA's Center for Devices and Radiological Health ("CDRH"), device companies need to conduct clinical trials that are more applicable to the real world. Kessler criticized the approach of many companies to look only to the short-term data needed to gain approval or clearance of a specific product and called for more emphasis on large, simple trials with clear clinical endpoints and eligibility criteria that encompass a larger portion of potential device users. Although Kessler agrees that not all trials need to be large, simple trials, he believes that those trials, which are narrowly tailored to a 510(k) or PMA, are too short-sighted. Kessler blames this short-sightedness for the growing criticisms from medical device reimbursers, the media, and Congress. Additional information is available at www.thegraysheet.com (paid subscription service).

International Sharing of GMP Inspection Results on the Horizon
In the near future, the results of manufacturing facility inspections conducted in one country will be made available to regulators in other countries. FDA is currently working to establish electronic systems to share regulatory auditing information among national authorities around the world as part of the Global Harmonization Task Force ("GHTF") National Competent Authority Report exchange program. The program is already functional for sharing adverse event reports and information on device returns, modifications, and destruction. The GHTF is now working to include audit reports in the exchange. Additional information is available at www.medicaldevicestoday.com or www.thegraysheet.com (paid subscription service).