Major players and medtech industry groups have offered their opinions as the FDA looks to review and improve its information collection requirements and regulatory oversight.
Commentary came in from companies Johnson & Johnson (NYSE:JNJ), Abbott (NYSE:ABT) and Cook Medical and industry groups AdvaMed, the Medical Imaging & Technology Alliance, the Pharmaceutical Research and Manufacturers of America and the American Hospital Association, amongst many others.
Across the board, companies and groups left commentary that was supportive of the FDA’s effort to reduce the burden on parties regulated by the agency to improve efficiency and innovation in the industry.
In its comments, J&J prioritized improving avenues for communicating drug and device data to healthcare professionals and payors, the ability to change labels without FDA approval and revising the FDA’s application of conflict of interest regulations in relation to advisory committee membership.
The company also supported the implementation of electronic labeling for drugs and medical devices, a continued pause on the FDA’s program for the voluntary reporting of quality data, simplification of electronic records and data regulations and a system that would allow initial marketing of breakthrough class III medical devices based of CE Mark approval.
Abbott offered multiple opinions on ways to improve medical device reporting and its associated regulations, including revised guidance and improved clarity on terms including ‘likely’, revising timeframes for malfunction reports and clarity on symbols in labeling.
The company also suggested the withdrawal of a proposed rule for electronic submission of labeling for certain home use devices, a removal of limitations related to class I or II point-of-care devices and their eligibility for 510(k) exemptions and the removal of the need for paper copies for 510(k) submissions.
In Cook’s comments, the company suggested clarified guidance related to certificates from foreign governments, clarification on IDE regulations as related to design control requirements, the withdrawal of a proposed revision on good laboratory practice for nonclinical laboratory studies and an indefinite stay on changes to the meaning of “intended use.”
Other comments included rescinding proposed rules requiring more documentation for clinical studies performed outside the US, changes to informed consent, the withdrawal of a proposed rule toking to require tracking of certain devices and changes to guidance and MDRs.
Medtech industry group AdvaMed provided a wealth of recommendations to the FDA’s CDRH, mostly in line with the comments form industry players, including conflicts with changes to intended use, labeling rules and electronic labeling and improved MDR rules.
In its letter, MITA opened with concerns about overlapping regulations for medical imaging devices, saying they were subject to both medical device regulations and electronic product regulations and that the FDA should modify electronic product regulations to remove applicability to medical imaging equipment.
The group also echoed concerns over MDR and the continued streamlining of the premarket notification process.
Drug and device-related group PhRMA offered its suggestions looking to solve issues with requirements related to both FDA unique device identifiers and National Drug Codes, clarity and revision to the definition of “combination products”, revised draft guidance related to human factors studies and concerns over electronic records.
PhRMA also echoed concerns over advisory committee conflict of interest policies and proposed solutions related to manufacturing policies related to combination products.
In its letter, the AHA spoke on issues concerning the need for increased oversight related to the cybersecurity of medical devices, referencing global ransomware attacks and increased cybersecurity events. The group urged the FDA to “proactively set clear measurable expectations for manufacturers before incidents and play a more active role during cybersecurity attacks.”
The AHA also voiced its concerns over patient access to compounded drugs, urging the FDA to eliminate a one-mile limitation to compounded products.
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Heidi Dohse: Sr. Program Manager, Healthcare, Google, Founder, Tour de Heart Foundation, Acessa Health Inc. Michael J. Pederson: Senior Vice President, Cardiac Arrhythmias and Heart Failure Division, Abbott Hon. Melvin Carter: Mayor, Saint Paul Tim Philips: Compliance Officer, FDA’s Office of Medical Device and Radiological Health Operations Dr. Myriam J. Curet, MD, FACS: Chief Medical Officer, Intuitive Surgical
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