Health and Human Services Seeks Public Comment on Making Exemptions Permanent During COVID-19 Including Digital Pathology Applications
Health and Human Services (HHS) is seeking public comments on making permanent regulatory flexibilities provided during the COVID–19 public health emergency by exempting certain medical devices from premarket notification requirements; request for information, research, analysis, and public comment on opportunities for further science and evidence-based reform of section 510(k) program.
This includes:
Digital Pathology Display
Digital Pathology Image Viewing And Management Software
This is very positive news for the digital pathology market in terms of the requirements for 510(k) regulations that manufacturers have been trying to obtain for their products. Digital pathology manufacturers have been mired in a lack of clear guidance and pathways for regulatory clearances from HHS/FDA for many years.
HHS Secretary Alex M. Azar II submitted this request as written in the Federal Register as captioned below.
Given this was submitted by a prior administration it is unknown whether or not this will stick and these exceptions/exemptions will be made permanent.
All interested stakeholders are encouraged to read the full notice and consider submitting comments.
Making Permanent Regulatory Flexibilities Provided During the COVID–19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
“To provide Americans with expanded access to certain medical devices to respond to the COVID–19 Public Health Emergency, FDA issued guidance documents providing numerous regulatory flexibilities, including a temporary waiver of premarket notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act. For seven class I devices for which 510(k) premarket review as temporarily waived during the PHE, the Department of Health and Human Services is permanently exempting those seven (7) class I devices from the 510(k) requirement and is also proposing to exempt an additional 83 class II devices and 1 unclassified device class from the 510(k) requirement, for which premarket review had also been waived during the PHE. The Department is soliciting the public’s views on whether premarket review should be permanently waived for some or all of these 83 devices and views on ways to improve the 510(k) premarket notification program.”
You may submit comments through the Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this rule making. All comments received will be posted to http://regulations.gov, including any personal information provided.
For access to the docket to read background documents or comments received, go to http://www.regulations.gov. Comments must be identified by 0991–ZA52. Because of staff and resource limitations, all comments must be submitted electronically to www.regulations.gov.
Follow the ‘‘Submit a comment’’ instructions. Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments may be posted on the internet and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to comments received. Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including personally identifiable or confidential business information that is included in a comment. You may wish to consider limiting the amount of personal information that you provide in any voluntary public comment submission you make. HHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov. Follow the search instructions on that website to view the public comments.
