NCHR Comments to FDA on Draft Guidance for Generic Abuse-Deterrent Opioids

We agree with many of the recommendations in the guidance and strongly urge the FDA to consider our recommendations regarding the use of the term “abuse-deterrent,” the development of guidance addressing additional abuse-deterrent technologies, the scrutiny applied to Tier 1 studies, and the enforcement of post-marketing study requirements for reference products. Continue reading

Letter to House Members opposing language added to the appropriations bill that lowers the FDA’s safety and efficacy standards for drugs and devices

April 15, 2016   The Honorable XXX YYY U.S. House of Representatives Washington, DC 20515   Dear Representative YYY,   The National Center for Health Research strongly opposes language added at the last minute to the House Agriculture, Rural Development, Food and … Continue reading

NCHR Supports Proposed FDA Regulation of Sunscreens

March 25, 2016. NCHR strongly supports the safety and effectiveness clinical and nonclinical testing requirements to obtain generally recognized as safe and effective (GRASE) status, as they are delineated in the draft guidance. The proposed testing requirements for new sunscreen chemicals will assure our country’s most vulnerable that the products will protect them from skin cancer and not cause unintended harm. Continue reading

Comments of members of the Patient, Consumer, and Public Health Coalition on “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications”

As members of the Patient, Consumer, and Public Health Coalition, we support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling. Continue reading

Letter to the U.S. Consumer Product Safety Commission regarding supplemental mattresses

October 13, 2015. The National Center for Health Research supports Keeping Babies Safe’s (KBS) petition that requests a ban on supplemental mattresses for play yards with non-rigid sides. These mattresses present an unreasonable risk of injury or death (suffocation) to infants and toddlers. Continue reading

Letter to the U.S. Consumer Product Safety Commission regarding Corded Window Coverings

June 1, 2015. We submit these comments in strong support of the U.S. Consumer Product Safety Commission’s (CPSC) development of a mandatory standard that prohibits hazardous, accessible window covering cords. A mandatory standard is needed because the current voluntary standard, which relies on warnings, has not significantly reduced the death rate Continue reading

Let your U.S. Senators know how you feel about unsafe medical products!

The House of Representatives passed a bill called 21st Century Cures that would lower the standards for approving drugs and medical devices. They say it will benefit patients, but it was written primarily by pharmaceutical and device companies and reflects their desire to get medical products approved on the basis of skimpier evidence than the law currently requires. Continue reading

Letter to the Dietary Guidelines for Americans Committee (DGAC) regarding the Dietary Guidelines for Americans (DGA)

May 8, 2015. The National Center for Health Research presents these comments on the expert report prepared for the eighth edition of the Dietary Guidelines for Americans (DGA) by the Dietary Guidelines for Americans Committee (DGAC). Overall, we strongly support the conclusions and policy recommendations in the report. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from any agricultural or food manufacturing industries, and have no conflicts of interest in making our recommendations. Continue reading

Letter to Congresswoman Rosa DeLauro Supporting “Helping Effective Antibiotics to Last” (HEAL) Act

February 12, 2015. The Centers for Disease Control and Prevention (CDC) points out that two major actions are urgently needed to address the threat posed by antibiotic resistance are: 1) stop the misuse of existing antibiotics, and 2) develop effective new antibiotics. HEAL is the first bill to focus on both these necessary actions. Continue reading

Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers

December 15, 2014. We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. The Cardiovascular Devices Panel stated on March 9, 1979 that these devices should be classified into Class III because the device “provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.” Continue reading

Comments on Internet/Social Media Platforms Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

October 29, 2014. We welcome the opportunity to provide feedback on this draft guidance regarding use of internet and social media platforms for communicating about medical products. Patients and consumers increasingly rely on social media and the internet as sources of health and medical information that influence their decisions to seek medical care. Continue reading

Comments on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications

October 14, 2014. We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments. When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention. Continue reading

Chantix Citizen Petition

October 8, 2014. Five leading nonprofit consumer, research and medical organizations identified below petition the Food and Drug Administration (FDA) pursuant to the Food, Drug, and Cosmetic Act 21 USC 352, 505(o)(4), and 21 CFR 10.30 to take action to improve the safety information included in the label for CHANTIX® (varenicline) tablets , a smoking cessation aid approved under NDA 021-928. Continue reading

Letter to Senator Waxman Expressing Concerns About Speeding Up the Development of New Antibiotic Drugs (ADAPT Act)

September 18, 2014. We are writing to express our strong concerns about proposed legislation to speed the development of new antibiotic drugs, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013. Antibiotic resistance is of grave concern, but this legislation will create more problems than it will solve. Continue reading

Comments on the Proposed Rule, “Medical Device Classification Procedures”

September 22, 2014. The Food and Drug Administration (FDA) is “proposing changes to the definition of class III to provide greater clarity regarding which devices fall within this class, and to improve transparency and predictability in device classification and reclassification decisions.” We commend the FDA for seeking clarity but we have grave concerns about the ways that the proposed rule weakens current definitions of class III devices. Continue reading

Letter to Senator Booker Supporting the Securing Assistance for Victim Empowerment (SAVE) Act

September 23, 2014. We strongly support this legislation to end the tax-exempt status of major professional sports leagues and use the money saved for domestic abuse programs. We strongly agree with your statement that “stopping domestic violence is a national priority that requires long-term, meaningful investment.” Continue reading

Comments on Draft Guidance for Industry on Internet/Social Media Platforms

September 16, 2014. This draft guidance only applies to companies who “voluntarily choose” to correct misinformation that appears on the Internet or through social media platforms from third party entities. However, companies should be held responsible for the accuracy and balance of all information about their product that appears to be promotional, not just for sources they voluntarily choose to correct. Continue reading

Comments on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices

August 25, 2014. With this draft guidance, the FDA is notifying manufacturers and others that it “does not intend to enforce compliance with regulatory controls that apply to” medical device data systems (MDDS), medical image storage devices, and medical image communications devices. The FDA has stated it is using its enforcement discretion on these devices because of “the low risk they pose to patients and the importance they play in advancing digital health.” We strongly disagree. Continue reading

Comments on Distributing Risk Information for Approved Prescription Drugs and Biological Products

August 25, 2014. As members of the Patient, Consumer and Public Health Coalition, we strongly urge the Food and Drug Administration (FDA) to withdraw its draft guidance proposing to allow pharmaceutical firms to distribute to health care providers and facilities scientific medical literature suggesting that the risk information for prescription drugs and biological products are less than what is stated in the FDA-approved product labeling. Continue reading

Comments on the Up-Classification of Flu Detection Tests

Members of the Patient, Consumer, and Public Health Coalition strongly support the up-classification of influenza detection devices. We support moving the devices from class I to class II with special controls and into a new device classification regulation (from 21 CFR 866.3330 to 21 CFR 866.3328). We agree with the FDA that “the accuracy of these devices has serious public health implications,” since influenza can cause serious illness and death. Continue reading

Comments on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Members of the Patient, Consumer, and Public Health Coalition appreciate the opportunity to comment on the draft guidance for the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.” We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.” Continue reading

Comments on proposed rule to allow FDA to regulate all tobacco products

As members of the Patient, Consumer, and Public Health Coalition we are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive. Continue reading

Comments urging FDA to provide higher standards and upclassify surgical mesh for POP and incontinence

On behalf of the National Center for Health Research, I am pleased to have the opportunity to express our views on the proposed order on the reclassification of certain surgical mesh devices and surgical instruments. Our nonprofit Center analyzes and reviews research on a range of treatment issues, and provides objective and understandable information to patients and providers. Continue reading

Letter to Congressman Cooper strongly supporting the Research for All Act of 2014

June 5, 2014. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Research for All Act. It would require the FDA to develop policies to ensure that clinical trials for medical products granted expedited approval are sufficient in design and size to determine the safety and effectiveness for men and women, using subgroup analysis. Continue reading

Comments of the National Center for Health Research On proposed order “Physical Medicine Devices: Reclassification and Renaming of Shortwave Diathermy of All Other Uses”

To view as PDF, click here. Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, Maryland 20852 May 21, 2014 Comments of the National Center for Health Research On proposed order “Physical Medicine Devices: Reclassification … Continue reading

Letter to FDA Commissioner Hamburg About Approving Cobas HPV Test Alone (Without Pap Smear) and FDA Response, April 2014

April 11, 2014. We are writing as members of the Patient, Consumer, and Public Health Coalition and other interested experts to express our grave concerns about the March 12, 2014 FDA meeting of the Microbiology Medical Devices Panel of the Medical Devices Advisory Committee. Under consideration was the premarket approval of a new indication for the Cobas HPV test, as a first-line primary screening tool for cervical cancer in women aged 25 and older.
Continue reading

Letter regarding Coalition Concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013

February 20, 2014. As members of the Patient, Consumer, and Public Health Coalition, which includes groups representing physicians, scientists, consumers, and patients, we are writing to express our concerns about H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013 Continue reading

Comments on the FDA’s Proposed Rule “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”

As members of the Patient, Consumer, and Public Health Coalition, we are pleased to have the opportunity to strongly support the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985). Continue reading

Comments on the FDA’s Draft Guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act”

As members of the Patient, Consumer, and Public Health Coalition, we conditionally support the draft guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (FD&C) because it clarifies FDA enforcement actions that can be taken against individuals or firms that illegally make drugs under the banner of traditional compounding. Continue reading

Comments on FDA Safety and Innovation Act Section 907 Report

The National Research Center for Women & Families strongly supports the requirement of the Food and Drug Administration Safety and Innovation Act (FDASIA) for an action plan to include demographic subgroups in clinical trials and data analysis. Greater diversity in clinical trials, analyzing subgroup data, and reporting the results and explaining the implications in product labels and MedGuides will shed light on which medical products are safe and effective for which demographic subgroups, including racial and ethnic minorities. Continue reading

Letter to FDA Regarding Advisory Committee Panel on Reclassification of CPR Devices

November 5, 2013. We are writing to express our strong concerns about the September 11, 2013 FDA meeting of the Advisory Committee for Circulatory System Devices. This Advisory Committee meeting discussed and made recommendations regarding the proposed down-classification of External Cardiac Compressor (ECC) devices. The panel members were asked to consider the FDA recommendation that ECC devices be reclassified from Class III (high risk) to Class II (moderate risk) with special controls. Continue reading

Coalition Letter to House Leaders in Opposition to Piecemeal Funding of FDA

October 4, 2013. We are writing as public health, patient, consumer, and scientific nonprofit organizations to oppose H.J. Res 77 and any other efforts to single out the Food and Drug Administration for funding.  Our organizations represent millions of patients, consumers, health professionals, and scientists who strongly support the work of the FDA and urge Congress to provide the level of appropriations the agency needs throughout FY 2014. Continue reading

Coalition Letter to Senator Harry Reid supporting Affordable Care Act and opposing repeal of excise tax on medical devices

September 26, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Patient Protection and Affordable Care Act (ACA) and oppose efforts to undermine this essential program that will benefit millions of Americans. In the upcoming negotiations over the budget and debt ceiling, we urge you to reject the repeal of the 2.3% excise tax on medical devices. Continue reading

Comments on Reclassification of Cardiovascular Devices; Intra-Aortic Balloon and Control Systems

September 17, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA’s proposed order for Intra-Aortic Balloon and Control Systems (IABP) devices used to treat septic shock or pulsatile flow generation (Other Specific Intended Uses) to remain in Class III with Premarket Approval applications (PMA) required. Continue reading

Letter to Senator Gillibrand in Support of the Military Justice Improvement Act

September 17, 2013. On behalf of the following nonprofit organizations from the Patient, Consumer, and Public Health coalition, we urge you to support Senator Kirsten Gillibrand’s (D-NY) Military Justice Improvement Act (S. 967) when it is offered as an amendment to the 2014 National Defense Authorization Act. Continue reading

Comments on Proposed Order “Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs”

September 10, 2013. As members of nonprofit patient, consumer, and public health organizations, we oppose the FDA proposed order that will reclassify stair-climbing wheelchairs (a Class III device, indicating high risk) into Class II (moderate risk). This change in classification would result in greater risk for some of our nation’s most vulnerable consumers.
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Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All”

September 9, 2013. Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All.” We are writing to express our strong support for the FDA’s efforts to improve how it communicates information on medical products to all Americans, and especially underrepresented subpopulations. Continue reading

Letter to the CA Bureau of Electronic and Appliance Repair in support of improved flammability standards for furniture

September 3, 2013. As a nonprofit organization dedicated to improving public health, the National Research Center for Women & Families strongly supports the proposed revisions of California’s flammability standards for upholstered furniture and other products. Continue reading

Comments on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina

August 19, 2013. We are writing as members of the Patient, Consumer, and Public Health Coalition to express our concerns about the proposed down-classification from Class III to Class II of External Counter-Pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization.  We strongly support the proposed PMA for other indications for the same ECP devices. Continue reading

Comments of the Patient, Consumer, and Public Health Coalition on Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning

August 7, 2013 Docket No. FDA-2013-N-0461   As members of the Patient, Consumer, and Public Health Coalition, we urge you to finally follow the recommendations made by FDA classification panels[end The General and Plastic Surgery Device Classification Panel and the Physical … Continue reading

Comments to FDA on “New Approaches to Antibacterial Drug Development”

July 30, 2013. As members of the Patient, Consumer, and Public Health Coalition, we recognize the need for new drugs to reach patients with serious or life-threatening diseases. The pipeline for new antibacterial drugs is shrinking. However, we have grave concerns about proposals to change the standards for meeting FDA’s requirement of two “adequate and well controlled” trials. Continue reading

Comments on proposed order “Requests for Ban or Standard on Adult Portable Bed Rails”

Comments of the National Research Center for Women & Families on Proposed Order “Requests for Ban or Standard on Adult Portable Bed Rails”: We are writing to urge the Consumer Product Safety Commission to take strong action to protect consumers from dangerous bed rails by either:
1) Establishing mandatory safety standards for adult portable bed rails with adequate warning labels, OR
2) Banning these bed rails if it is determined that they cannot be made safe. Continue reading

Comments on Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System

June 24, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA proposed order that will require the premarket approval application (PMA) for Automated External Defibrillators systems (AEDs). However, we oppose the FDA exercising an enforcement discretion that would allow 510(k) cleared AEDs to remain on the market for 15 months after FDA issues a final order requiring a PMA for these devices. Continue reading

Letter to Congressman Markey in Support of VALID Act About Compounding Pharmacies

May 22, 2103. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2013. This bill would significantly strengthen FDA oversight of compounding pharmacies and help ensure patients get safe and effective life-saving medical products. Continue reading

Comments to the FDA on “Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis”

The National Research Center for Women & Families and the TMJ Association oppose the reclassification of Temporary Mandibular Condyle prosthesis, a preamendments class III device, into class II. The proposed special controls are not rigorous enough to provide a reasonable assurance of the device’s safety and effectiveness. Continue reading

Comments on Proposed Order Regarding Transilluminator for Breast Evaluation

May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for Transilluminator for breast evaluation devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness. Continue reading

Comments on Proposed Order Regarding Sorbent Hemoperfusion Devices

May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for sorbent hemoperfusion devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.[1] We strongly oppose down- classifying the devices for the treatment of poisoning and drug overdose. Continue reading

Comments on Proposed Order Regarding Cranial Electrotherapy Stimulator Devices

May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for cranial electrotherapy stimulator devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness. Continue reading

Letter from Members of the Patient, Consumer, and Public Health Coalition Re: HELP Committee’s Draft Proposal on Pharmaceutical Compounding

May 6, 2013. The Patient, Consumer, and Public Health Coalition expressed concern that the draft does not adequately address the public health threats posed by compounding pharmacies and will not do enough to prevent future health care crises. The Coalition provided comments on how to improve the draft to better protect the American public. Continue reading

Comments on Effective Date for Premarket Approval for Three Class III Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose

May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for the three preamendment devices referred to in this docket because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness. Continue reading

Letter to Key U.S. Senators in Support of Funding for the Affordable Care Act

April 2, 2013. Like you, members of the Patient, Consumer, and Public Health Coalition are very supportive of the Patient Protection and Affordable Care Act (ACA). We were extremely disappointed that the Hatch-Klobuchar amendment (S. Amdt. 297 to S. Con. Res. 8) to repeal the 2.3% excise tax on medical devices was overwhelmingly supported. Thank you very much for your important vote against the amendment. Continue reading

Letter in support of the Delivering Antimicrobial Transparency in Animals Act

April 2, 2013. Letter to Representatives Henry Waxman and Louise Slaughter supporting the DATA act, which would require better reporting of how antibiotics are used in animals raised for food. This information is critical to understanding how antibiotic resistant bacteria in food animals affects human health. Continue reading

Letter to Congressman Edward J. Markey regarding the VALID Compounding Act of 2012

October 31, 2012. As members of the Patient, Consumer, and Public Health Coalition, we thank you for your commitment to the health of patients and consumers by introducing the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012. This bill would strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths. Continue reading

Letter from Members of the Patient, Consumer, and Public Health Coalition Re: FDA’s Recent HELP Committee testimony on pharmacy compounding

November 30, 2012. As members of the Patient, Consumer, and Public Health Coalition, we welcome the opportunity to provide our views regarding FDA Commissioner Margaret Hamburg’s November 15, 2012 testimony at the HELP Committee hearing, “Pharmacy Compounding: Implications of 2012 Meningitis Outbreak.” Continue reading

Letter from Members of the Patient, Consumer, and Public Health Coalition Re: “Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding”

November 2, 2012. Members of the Patient, Consumer, and Public Health Coalition welcome the opportunity to provide our views regarding pharmacy compounding.  Stronger regulations are clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.  Current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk. Continue reading

Letter to Dr. Joshua Sharfstein, Maryland’s Secretary of Health, in support of banning the sale of baby bumper pads in Maryland, September 28, 2012

September 28, 2012. The ASTM standard that claims some bumper pads are less risky will muddle the safety issue even more and give parents a false sense of security. Maryland’s proposed ban on crib bumper pads will help to protect more than 70,000 babies born in the state each year, and that is a bottom line upon which we should all agree. Continue reading

Comments on Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses

October 4, 2012. Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA’s proposed rule to require Premarket Approval Application (PMA) for the Class III preamendments device Shortwave Diathermy (SWD) for all other uses except for the treatment of malignancies. However, we oppose FDA’s proposal to allow a Product Development Protocol (PDP) instead of a PMA for this device because PDPs are for devices where a sponsor comes to an “early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.” FDA has stated unequivocally that SWD devices “have not been shown to be safe and effective” therefore, the devices have no public health benefits, and that also rules out the use of a PDP. Continue reading

Comments on Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; Effective Date of Requirement for Premarket Approval for Sorbent Hemoperfusion Devices To Treat Hepatic Coma and Metabolic Disturbances

May 17, 2012. To ensure public health and patient safety, sorbent hemoperfusion devices for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances should remain class III devices and go through the more stringent PMA process, which requires clinical trials and inspections. Continue reading