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Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.
GAO: FDA Medical Device Review Timeframes Increasing
A new report from the US Government Accountability Office (GAO) provides yet more data showing that total average review times for FDA 510(k) medical device applications has increased despite the regulator’s meeting other 510(k)-related performance goals.
Specifically, the average total time from 510(k) application submission to final decision increased from 100 days in 2005 to 161 days in 2010—an increase of 61%. However, the report also points out that the FDA has reviewed more than 90% of 510(k) submissions within 90 days each year since 2005; the agency was also able to review 98% of all 510(k) submissions within 150 days. It is important to note that FDA “review times” exclude the time it takes for manufacturers to respond to FDA requests for additional information on their submissions, whereas the total time periods evaluated by the GAO do include time required to respond to additional requests for information from the agency.
Furthermore, the GAO found inconsistencies when it came to FDA reviews of pre-market approval (PMA) applications. For “original” or standard PMAs, the FDA met its performance goals for four out of seven years that those performance goals were in place, but for “expedited” PMAs—available for devices deemed to treat or diagnose life-threatening diseases and meet unmet medical needs—the FDA met its performance goals for only two of the seven years of record.
GAO investigators interviewed industry and consumer advocacy groups as part of its study. Based on these interviews, the report identifies four most common complaints regarding dealing with the FDA for medical device clearances and approvals:
- Inadequate communication between FDA reviewers and stakeholders
- Lack of predictability and consistency in reviews
- Increasing time to final decisions
- Insufficient assurance from the FDA regarding devices’ safety and effectiveness
The GAO study clearly breaks no ground in terms of FDA medical device review times—other studies have also come to similar conclusions. What these findings perhaps most importantly demonstrate, however, is the need for manufacturers to make every effort to ensure they do not have to deal with additional requests for information from the regulator.
Markets: USATags: 510(k), 510-k, 510k, FDA, GAO, Government Accountability Office, medical device, PMA, premarket approval
Author: Stewart EisenhartDate: April 2, 2012
FDA Explains Electronic Study Data Submission Expectations
New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format standardized study data for electronic submission.
The guidance pertains to submissions of clinical and non-clinical data related to Investigational Device Exemptions (IDEs), premarket notifications (510(k)s) and premarket approval applications (PMAs) submitted to the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research and other medical device and pharmaceutical review divisions of the FDA.
Planning and Provision of Standardized Data
First, study sponsors should include descriptions of their standardized study submission plans in their IDEs. These plans must also be included in the Data Management Plan sections of sponsors’ IDE study protocols, and lay out which data standards sponsors intend to use. (Any studies that will not be standardized should also be described, along with explanations for using non-standardized studies.)
Controlled Terminologies
Second, the guidance recommends that study sponsors utilize terminology standards such as CDRH Event Problem Codes as part of their standardized electronic submission efforts. This makes FDA analysis of study data more efficient. The FDA Study Data Standards Resources Web Page lists all terminology standards currently accepted by agency divisions.
Standardization of Previously Collected Nonstandard Data
In cases where study data elements cannot be readily converted to standardized formats, sponsors should document why such data could not be fully standardized. In addition, sponsors should identify which studies contain nonstandard data that were converted to standard formats.
Data Validation
Sponsors should also conduct data validation prior to sending their submissions to the FDA. The agency recognizes two major validation rules: technical validation rules to ensure data submitted conforms to standards, and business validation rules to ensure that data will support relevant business processes as intended.
FDA Meetings
Finally, the guidance recommends using FDA-sponsor meetings such as pre-IDE meetings to point out any outstanding study data standardization issues. In addition, sponsors and manufacturers can send technical questions at any time to CDRH and/or CBER technical support teams.
Markets: USATags: 510(k), 510k, clinical study, FDA, IDE, investigational device exemption, medical device, PMA
Author: Stewart EisenhartDate: February 22, 2012
GAO Finds FDA Data on Pediatric Devices Lacking
A recent report by the US Government Accountability Office (GAO) finds that the Food and Drug Administration has not consistently taken steps to identify and track medical devices designated for pediatric use.
The FDA Amendments Act of 2007 (FDAAA), implemented in part to spur development of more medical devices to treat pediatric populations, requires the FDA to identify all devices labeled for use in pediatric patients, and provide annual reports to Congress on the numbers of such devices approved. Although the agency has the capability to identify pediatric devices in its existing internal tracking system, the GAO report contends that the capability has not been consistently used to do so. As such, the FDA’s data on pediatric devices is not reliable or timely, according to the GAO.
GAO reviewers identified 18 devices brought to market either via the FDA’s Humanitarian Device Exemption (HDE) or premarket approval (PMA) process since the FDAAA went into effect; but reviewers also found that indications for use statements for 72% of all devices approved via HDE or PMA had no patient-age-specific information, meaning that additional pediatric devices could be on the US market.
The GAO recommends more consistent use of existing electronic flagging capabilities by FDA personnel in order to better account for the amount of pediatric medical devices marketed in the US.
Markets: USATags: FDA, GAO, HDE, medical device, pediatric medical device, PMA
Author: Stewart EisenhartDate: January 11, 2012
New FDA Guidance Emphasizes Gender Differences in Clinical Studies
New draft guidance from the US Food and Drug Administration recommends improvements to medical device manufacturers’ clinical study designs in order to better assess safety and effectiveness of their products according to gender.
The guidance aims to suggest methods to enroll more women in clinical studies in order to better represent demographic distributions of particular diseases; identify statistical analyses of study data that take into account gender differences; emphasize the need to consider gender differences during manufacturers’ study design phases; and spell out expectations of the Center for Devices and Radiological Health (CDRH) for reporting of sex- and gender-related information in study summaries and labeling for approved or cleared devices.
“Certain medical products elicit different responses in women compared to men,” the guidance states, citing ventricular assist devices and cardiac resynchronization therapy defibrillators as examples of devices with significant differences in effectiveness between male and female patients.
“Many clinical studies do not enroll proportions of women that reflect the underlying disease distribution in the affected population… This has contributed to a substantial lack of available data regarding the risks and benefits of medical device use in women.”
Historical barriers to enrollment of women in clinical studies, according to the FDA, include fears of fetal consequences, avoidance of female subjects by study sponsors, and study inclusion or exclusion criteria that inadvertently exclude women. To reduce these challenges, study sponsors and manufacturers should examine screening logs in order to track reasons for non-enrollment of women as subjects.
What to include in submission documents
The guidance recommends inclusion of information such as sex-specific prevalence of the disease in question, sex-specific diagnosis and treatment patterns, identification of proportions for women included in past clinical studies, and identification of any known clinically significant sex differences in outcomes regarding safety or effectiveness.
For new and ongoing studies, manufacturers and sponsors should include the afore-mentioned data as components of the risk analysis sections of their investigational plans. Firms should also summarize this information in their study protocols and training materials.
For completed studies, this data should be included as part of your marketing application under clinical investigation results. A draft PMA Summaries of Safety and Effectiveness or 510(k) Summary should also include this information.
Finally, for postmarket studies, this information should be included in interim reports as well as the results sections of final reports.
Other Recommendations
In addition, the FDA guidance recommends clinical study investigators take into account how the influence of subjects’ sex affects primary endpoints for safety and effectiveness. Analysis of subgroups and testing for interaction or heterogeneity may also be necessary, according to the agency.
Statistical analysis must also address sex-specific issues, recommends the FDA. Any clinically significant sex differences should be reported and discussed with FDA personnel to see whether further investigations are required based on those findings. Sex-specific information should also be reflected more thoroughly in study summaries and labeling, according to the guidance.
Markets: USATags: 501(k), 510k, clinical study, FDA, PMA, postmarket surveillance, premarket approval
Author: Stewart EisenhartDate: December 19, 2011
FDA Guidance on HUD Designations Out for Comment
The US Food and Drug Administration has opened a 90-day comment period for draft guidance on Humanitarian Use Device (HUD) designations.
The HUD designation program, run by the Office of Orphan Products Development (OOPD), enables qualifying medical devices to be considered for marketing approval via a Humanitarian Device Exemption (HDE) application. HDE applications are similar to premarket approval applications, but do not require manufacturers to demonstrate reasonable assurances of effectiveness.
The draft guidance covers the following HUD-related issues:
- Demonstrating that the device seeking HUD designation targets diseases affecting less than 4,000 people annually in the US
- Variations of that demonstration depending on whether the device is designed for therapeutic or diagnostic use
- How device properties affect that demonstration
- Definition of a plausible patient population for the disease in question
Interested parties have 90 days to submit comments on the FDA’s proposals.
Markets: USATags: FDA, HDE, HUD, Humanitarian Device Exemption, Humanitarian Use Device, PMA, premarket approval
Author: Stewart EisenhartDate: December 14, 2011
PMA Summary Review Database Now Available from CDRH
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has launched a new searchable database of premarket approval (PMA) summary review memos.
The CDRH defines 180-day supplements as requests for significant changes in components, materials, design or other factors to a previously approved premarket application or report. The new database specifically provides information on PMA summary review memos for 180-day design changes.
The database is part of the CDRH Transparency Initiative, a pilot program launched by the FDA. Updates to the database will occur every Sunday, according to the agency.
Markets: USATags: CDRH, FDA, medical device, PMA, premarket approval
Author: Stewart EisenhartDate: November 1, 2011
FDA: PMA Requirements for Surgical Mesh Devices Possible
The US Food and Drug Administration appears likely to require premarket assessments rather than premarket notifications for surgical mesh devices used to treat pelvic organ prolapse (POP) but not for stress urinary incontinence (SUI) in women.
According to a recently posted FDA executive summary, the agency’s Obstetrics & Gynecology Devices Advisory Committee will meet September 8th and 9th to reconsider surgical mesh products’ current Class II classification based on clinical literature and adverse event data culled from the Manufacturer and User Device Experience (MAUDE) database.
Regarding surgical mesh products used in vaginal POP procedures, the agency recommends reclassification of these devices to Class III and requiring PMAs due to safety and effectiveness concerns stemming from literature and medical device report reviews. In addition, the FDA believes post-market surveillance of these products should be required going forward.
For surgical mesh products used to treat SUI, the FDA came to a different conclusion. Reclassification of these products to Class III is not warranted, according to the agency, and clinical trials are not necessary for first-generation devices used in minimally invasive SUI treatments. Second-generation products, however, require both premarket performance data as well as post-market surveillance data according to FDA findings. All mesh products used in SUI procedures, however, can be properly monitored according to Special Controls provisions of the 510(k) process.
According to The Wall Street Journal, roughly nine manufacturers including Boston Scientific and Johnson & Johnson would be affected by a potential reclassification of surgical mesh devices.
August 23rd Deadline for FDA Final Rule on Three Obsolete Class III Devices
A final FDA rule affecting ventricular bypass devices, pacemaker repair or replacement material and female condoms goes into effect August 23, 2011. The rule requires manufacturers to file premarket approval applications (PMA) or product development protocols within 90 days of the final rule or cease commercial distribution of their products.
These Class III devices had previously gone through the FDA’s 510(k) premarket notification process as pre-amendment devices that were in distribution prior to the addition of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.
Specific product codes affected by the final rule are OBY, OKR and KFJ. However, the final rule’s impact is expected to be minimal: all three products have fallen into disuse, and no premarket submissions for any of these device types have been made in several years. (The pacemaker repair and replacement device was last marketed in 2001, and the female condom was last marketed in the 1930s.)
Unsurprisingly, the FDA received no comments from industry on the proposed rule, and expects interest in marketing such devices to stay low (or nonexistent).
FDA Draft Guidance Identifies Benefit-Risk Factors Used for Premarket Reviews
The US Food and Drug Administration has published draft guidance on the factors agency reviewers use to make benefit-risk decisions for premarket approval (PMA) medical device applications.
In making these factors public, the regulator hopes to improve predictability, consistency and transparency of its PMA process (as well as some 510(k) reviews).
First, the FDA considers measures for effectiveness of devices. Under this category, reviewers measure the type, magnitude and probability of benefits provided by a device, as well as the duration of those benefits for the patient.
Second, the agency considers measures for safety of devices. These include device-related serious and non-serious adverse events, procedure-related or indirect harms stemming from the device under consideration, and probability and duration of harmful events. Risks from false-positive or false-negative results produced by diagnostic devices also fall under this category of factors.
Additional factors the FDA lists in the guidance include uncertainty in terms of reviewers’ ability to determine reasonable assurances of safety and effectiveness; characterization of the disease or condition a device is designed to diagnose or treat; patient tolerance for risk, which can be affected by issues such as disease severity and chronicity; availability of alternative treatments; use of risk mitigations such as warning labelsto minimize the likelihood of harmful events; and novelty of technology used in a particular device.
The guidance also includes examples of how FDA reviewers use multiple combinations of factors to evaluate benefits and risks of particular medical devices. The FDA has also provided a draft of a Worksheet for Benefit-Risk Determinations in order to maintain more consistency in the PMA process, especially for devices requiring reviews across different agency divisions.
Markets: USACategories: Regulatory ComplianceTags: 510(k), FDA, medical device, PMA, Premarket Review
Author: Stewart EisenhartDate: August 15, 2011
FDA Modifies List of Standards Used in Premarket Reviews
The US Food and Drug Administration has announced changes to its recognized consensus standards used in premarket reviews of medical devices.
Now in effect, the changes include additions, withdrawals, corrections and revisions and are grouped under “Recognition List Number: 027” in the FDA’s searchable database.
Modifications to the FDA’s list of recognized standards affect cardiovascular, ophthalmic, orthopedic, sterility, general and materials categories. New entries and consensus standards added to Recognition List Number: 027 cover multiple areas, including anesthesia, IVD, nanotechnology and ophthalmic categories.
Although the changes have already gone into effect, the FDA is accepting public comment on its modified list of standards on an ongoing basis. Medical device manufacturers planning to apply for premarket reviews of their products should check the revised list of consensus standards to ensure conformity.
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