Device Export Fees, GUDID, PDUFA, and Other Regulatory News
Monday, August 31, 2015
Posted by: Katie Trevathan
New Device Export Certificate Fees
The FDA issued a Federal Register (FR) Notice announcing revised fees for medical device export certificates that will go into effect on September 1, 2015. This is the second time the FDA has changed the fees for these certificates since the start of the export certification program in 1996.
Since the last fee change in February 2003, the FDA's costs to process medical device export certificates have increased. Because of this, the agency is revising the formula used to calculate the number of original and subsequent device export certificates issued and raising the fee for subsequent certificates. These changes are necessary to ensure that the program remains self-sustaining.
Learn more about exporting medical devices here.
FDA-CDRH Joins International Device Regulatory Harmonization Pilot Program
The FDA’s Center for Devices and Radiological Health (CDRH) is set to begin participation in the International Medical Device Regulators Forum (IMDRF)’s Regulated Product Submission Table of Contents (RPS ToC) Pilot Program. IMDRF is a voluntary group of medical device regulators from around the world, including the FDA, who have come together to accelerate international medical device regulatory harmonization and convergence. IMDRF developed In-Vitro Diagnostic (IVD) and non-IVD Tables of Contents (ToCs) intended to provide internationally agreed upon formats that sponsors can use to file medical device submissions to participating regulatory authorities for premarket clearance or approval.
Starting on September 1, 2015, CDRH is participating in the voluntary IMDRF Regulated Product Submission Table of Contents (RPS ToC) pilot program to test the usability of the internationally agreed upon format.
Sponsors who are submitting a Premarket Notification (510(k)) or Premarket Approval (PMA) applications to either CDRH’s Office of Device Evaluation or Office of In Vitro Diagnostics and Radiological Health, and who are also submitting the application to another participating regulatory authority are eligible to participate. Currently the participating regulatory authorities are Australia (Therapeutic Goods Administration), Brazil (ANVISA), Canada (Health Canada), China (China Food and Drug Administration), and the European Union (Notified Bodies).
For more information about this pilot and CDRH’s participation, please see the pilot’s formal announcement in the Federal Register.
For questions related to the IMDRF pilot, please send an email to email@example.com. For questions pertaining to CDRH participation in the pilot, please contact Jodi Anderson at Jodi.Anderson@fda.hhs.gov.
PDUFA VI Reauthorization Process Kicks Off
The reauthorization of the next iteration of the Prescription Drug User Fee Act, PDUFA VI, began in mid-July with a public hearing attended by drugmakers, FDA, industry organizations, as well as patient/disease advocacy organizations and other stakeholder groups. The hearing set the stage for monthly discussions with industry beginning this fall and regular meetings for FDA to hear the views of patient, consumer and health professional representatives.
The importance of the PDUFA program to FDA was apparent in appearances at the meeting by acting commissioner Stephen Ostroff and deputy commissioner Robert Califf, both new to the agency’s negotiating process. Dr. Janet Woodcock, CDER Director, highlighted the importance of patient input in drug development and review, interest in expanding FDA’s Sentinel program to strengthen oversight of postmarketing safety, and further efforts to bolster regulatory science. She noted that CDER “continues to struggle” with the recruitment and retention of top scientists that is key to achieving a more predictable and efficient drug development and approval program.
Theresa Mullin, PhD, Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research (CDER) – and the agency official responsible for PDUFA negotiations - noted that high-level priorities are to continue to enhance the drug review process and its predictability; to maintain a fair and efficient fee structure, and to use funds to hire and retain top talent for the agency. She discusses the reauthorization process in a recent blog post.
Patient groups and professional organizations including PhRMA and BIO proposed a range of initiatives meriting PDUFA support: validation of more biomarkers and patient reported outcomes (PROs), pediatric and neonatal drug development, expanded use of registries, data transparency initiatives, and greater consistency across CDER review divisions on acceptance of expedited review pathways.
A hot topic for industry is ensuring long-term stability for PDUFA by clarifying that user fees are not subject to future budget sequestration actions. Under sequestration three years ago, a portion of industry fees were unavailable to FDA, delaying important regulatory science initiatives and enhancements. MichBio and other state industry associations, along with BIO and PhRMA, continue to lobby Congress to permanently safeguard user fees from sequestration.
UDI Database Submission Dates Extended Due to Online Security Issues
A guidance has been posted titled, “Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff.”
On September 24, 2013, the FDA issued regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices (78 FR 58786) (the UDI Rule). FDA established a set of compliance dates, by device classification, for compliance with required labeling and data submission to the Global Unique Device Identification Database (GUDID) under the UDI Rule. For class III devices and devices licensed under the Public Health Service Act, the compliance date was September 24, 2014. FDA granted requests for extensions to the compliance date some of which expire on September 24, 2015. For implantable, life sustaining and life supporting devices (other than class III devices which had a compliance date of September 24, 2014), the compliance date is September 24, 2015.
On August 7, 2015, due to a security vulnerability in GUDID, FDA decided to take the system offline until a patch is implemented. As a result FDA extended the September 24, 2015, GUDID submission compliance date for the implantable, life-supporting and life-sustaining medical devices to October 24, 2015. For extensions granted to class III labelers that expire between August 7 and September 24, 2015, the FDA extended the expiration date of these extensions to October 24, 2015.
Guidance Issued for Drug Development for Rare Diseases
The FDA issued a draft guidance for industry entitled, “Rare Diseases: Common Issues in Drug Development.” This draft guidance document is intended to assist sponsors of drug and biological products for treating rare diseases in conducting more efficient and successful development programs.
Botanical Drug Development Guidance Released
The FDA announced the availability of a draft guidance for industry entitled, “Botanical Drug Development.” This draft guidance document describes the Agency’s current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs, as well as provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs.
Exempted Devices List Modified
The FDA’s CDRH issued a guidance entitled, “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.” This guidance document updates an earlier guidance of the same title published in the Federal Register on July 1, 2015, and includes additional devices and product codes believed to be sufficiently well understood and do not require premarket notification to assure their safety and effectiveness.